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  • A Phase 1, Open-Label, Multicenter Study of HMPL-306 in Advanced Hematological Malignancies with Isocitrate Dehydrogenase (IDH) Mutations. - NCT04762602

    Primary Objectives: Part 1: To evaluate the safety and tolerability of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations Part 2: To characterize safety and tolerability, and to determine RP2D of HMPL-306 in subjects with locally advanced hematological malignancies that harbor IDH mutations Secondary Objectives: 1. To assess preliminary antitumor activity of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations 2. To assess the PK of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations. 3. To assess PD of HMPL-306 in subjects with advanced hematological malignancies that harbor IDH mutations.

    View All Details
    • Protocol Number:
      022004

    • Principal Investigator:
      Anupama Doraiswamy M.D

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      HMPL-306

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anupama Doraiswamy M.D

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      Subjects are eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):
    • Subjects aged ≥18 years.
    • ECOG performance status 0 or 1
    • Subjects must have a documented IDH mutation per immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor tissue.
    • Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists.

    Key Exclusion Criteria:

      Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list):
    • Subjects who received an investigational agent <14 days prior to their first day of study drug administration
    • Subjects who are pregnant or breastfeeding
    • Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever >38.3°C during screening visits or on their first day of study drug administration.
    • Subjects with some current or prior heart conditions
    • Subjects taking medications that are known to prolong the QT interval may not be eligible
    • Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
    • Some subjects with some current or prior gastrointestinal or liver diseases
    • Subjects with inadequate organ function as defined by the protocol

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL). - NCT02981628

    Primary Aim: To determine the morphologic response rate (complete response [CR] + complete response with incomplete hematologic recovery [CRi]) following one cycle of treatment with InO in children with relapsed or refractory CD22+ B-ALL. 1.2 Secondary Aims 1.2.1 To determine the CR/CRi rate following 2 cycles of InO therapy. 1.2.2 To determine the safety of single agent InO administered at the adult recommended phase 2 dose (RP2D) to pediatric patients with relapsed or refractory CD22+ B-ALL. 1.2.3 To determine the level of minimal residual disease (MRD) by flow cytometry in responding patients. 1.2.4 To determine the incidence, severity, and outcomes of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver in patients during InO therapy and following subsequent treatment, including myeloablative hematopoietic stem cell transplantation (HSCT). 1.2.5 To estimate the 3-year event-free survival (EFS), 3-year overall survival (OS), and among responders, duration of CR/CRi for pediatric patients with relapsed or refractory B-ALL treated with InO. 1.3 Exploratory Aims 1.3.1 To assess the level of CD22 surface expression and CD22 site density on leukemic blasts and correlate with clinical outcomes after treatment with InO.

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    • Protocol Number:
      111707

    • Principal Investigator:
      Archana Sharma DO

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Lymphoid Leukemia

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Inotuzumab ozogamicin (CMC-544)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Archana Sharma DO

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Patients must be >= 1 year and < 22 years of age at the time of enrollment
    • Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
    • NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
    • Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing >= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
    • Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended)
    • In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
    • Patients with one of the following:
    • Second or greater relapse;
    • Primary refractory disease with at least 2 prior induction attempts;
    • First relapse refractory to at least one prior re-induction attempt
    • Any relapse after HSCT (Cohort 1 ONLY) Patients with Down syndrome are eligible ONLY for Cohort 1 with:
    • Any of above disease status, OR
    • First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy
    • Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
    • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2:
    • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
    • A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate).
    • A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment
    • >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, >= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.
    • Note: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy.
    • Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment.
    • Anti-cancer agents that are antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria.
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction.
    • Radiotherapy: >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
    • Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.
    • Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
    • A serum creatinine based on age/gender as follows:
    • 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
    • 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
    • 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
    • 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
    • 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
    • >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
    • Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
    • Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L

    Exclusion Criteria:

    • Patients with any prior history of SOS irrespective of severity
    • Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse
    • Patients who have been previously treated with inotuzumab ozogamicin
    • Patients who have previously received HSCT (Cohort 2 only)
    • Patients with Down syndrome (Cohort 2 only)
    • History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study
    • Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 (dose levels 1 and -1) if Erwinia formulation of asparaginase can be obtained
    • If Cohort 2 is enrolling at dose level -2, then patients who cannot receive asparaginase due to prior allergy, toxicity, or lack of access may enroll
    • NOTE: patients on AALL1621 are not eligible to co-enroll on AALL1931
    • Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement
    • Patients who are currently receiving another investigational drug
    • Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
    • Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications
    • Patients who are currently receiving or plan to receive corticosteroids except as described below
    • Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
    • Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient
    • Patients who have an active uncontrolled infection defined as:
    • Positive bacterial blood culture within 48 hours of study enrollment;
    • Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability
    • A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
    • Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline
    • Active viral or protozoal infection requiring IV treatment
    • Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome
    • There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment
    • Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin
    • Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin
    • Lactating females are not eligible unless they agree not to breastfeed their infants

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase 3 Randomized Trial for Patients with de novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations. - NCT04293562

    1. To compare event-free survival (EFS) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy on Arm A (DA-GO) with daunorubicin, cytarabine (DA) and gemtuzumab ozogamicin (GO) versus Arm B with CPX-351 and GO. 2. To compare overall survival (OS) and rates of end of Induction 1 (EOI1) minimal residual disease (MRD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B). 3. To estimate the EFS and rate of EOI1 MRD in FLT3 internal tandem duplication mutation positive patients (FLT3/ITD+; as defined by allelic ratio > 0.1) without favorable cytomolecular characteristics (NPM1 and/or CEBPA) receiving gilteritinib in combination with DA GO (Arm AC). 4. To estimate the EFS and rate of EOI1 MRD in patients with non-ITD FLT3 activating mutations who receive backbone therapy (DA-GO or CPX-351 and GO) with gilteritinib (Arms AD and BD). 5. To determine the feasibility of combining gilteritinib and DA-GO or CPX-351 and GO in patients with FLT3/ITD mutations (Arm AC/Arm BC/Arm AD/Arm BD). 6. To compare EOI1 MRD and EFS in patients with FLT3/ITD AML+ (AR > 0.1) without favorable cytogenetic/molecular characteristics treated with DA-GO-gilteritinib vs CPX-GO-gilteritinib (Arm AC vs Arm BC). 7. To compare the incidence of significant left ventricular systolic dysfunction (LVSD) in children with de novo AML without FLT3 mutations who are randomly assigned to standard induction therapy (Arm A) with DA-GO versus CPX-351 and GO (Arm B). 8. To compare the changes in echocardiography-derived measures of cardiac function, including left ventricular ejection fraction (EF) and global longitudinal strain (GLS), throughout AML therapy in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B. 9. Determine if early changes in sensitive echocardiographic measures of cardiac function (i.e., post-Induction 1 decline in GLS) and elevations in circulating cardiac biomarkers (i.e., cardiac troponin T and N-terminal pro b-type natriuretic peptide) are associated with subsequent declines in left ventricular ejection fraction in patients with non-FLT3 mutant AML receiving therapy on Arms A or B. 10. To compare longitudinal acute changes in neuropsychological functioning and neurocognitive late effects between those with CNS disease and those without CNS disease and between those treated with HSCT and those treated with chemotherapy only for patients on Arms A and B. 11. To compare cardiotoxicity measures (EF, GLS, and cardiac biomarkers) in patients receiving standard induction with dexrazoxane vs. CPX-351 in the context of gilteritinib therapy and explore whether the differential cardiotoxicity across arms varies from that observed in non-FLT3 mutant AML without gilteritinib exposure. 12. To estimate the EFS and rate of EOI1 MRD in patients with high allelic ratio (HAR) FLT3/ITD+ patients, as historically defined by an AR > 0.4, receiving gilteritinib in combination with DA-GO (Arm AC with AR > 0.4). 13. To estimate the EFS and rate of EOI1 MRD in FLT3/ITD+ patients (as defined by allelic ratio > 0.1) with NPM1 and/or bZIP CEBPA mutations receiving gilteritinib in combination with DA-GO (Arm AC). 14. Compare the changes in high sensitivity troponin and natriuretic peptide elevations throughout AML therapy, as measured at the end of each chemotherapy course, in patients with low and high risk AML without FLT3 mutations receiving Arm A vs Arm B

    View All Details
    • Protocol Number:
      112008

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CPX-351 Gilteritinib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • All patients must be enrolled on APEC14B1 and consented to Eligibility Screening (Part A) prior to enrollment and treatment on AAML1831. Submission of diagnostic specimens must be done according to the Manual of Procedures
    • Patients must be less than 22 years of age at the time of study enrollment
    • Patient must be newly diagnosed with de novo AML according to the 2016 World Health Organization (WHO) classification with or without extramedullary disease
    • Patient must have 1 of the following:
    • >= 20% bone marrow blasts (obtained within 14 days prior to enrollment)
    • In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy
    • < 20% bone marrow blasts with one or more of the genetic abnormalities associated with childhood/young adult AML as provided in the protocol (sample obtained within 14 days prior to enrollment)
    • A complete blood count (CBC) documenting the presence of at least 1,000/uL (i.e., a white blood cell [WBC] count >= 10,000/uL with >= 10% blasts or a WBC count of >= 5,000/uL with >= 20% blasts) circulating leukemic cells (blasts) if a bone marrow aspirate or biopsy cannot be performed (performed within 7 days prior to enrollment)
    • ARM C: Patient must be >= 2 years of age at the time of Late Callback
    • ARM C: Patient must have FLT3/ITD allelic ratio > 0.1 as reported by Molecular Oncology
    • ARM C: Patient does not have any congenital long QT syndrome or congenital heart block
    • ARM C: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
    • ARM C: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
    • ARM C: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
    • ARM D: Patient must be >= 2 years of age at the time of Late Callback
    • ARM D: Patient must have one of the clinically relevant non-ITD FLT3 activating mutations as reported by Foundation Medicine
    • ARM D: Females of reproductive potential must agree to use effective contraception during treatment and for at least 6 months after the last dose of gilteritinib
    • ARM D: Lactating women must agree not to breastfeed during treatment with gilteritinib and for 2 months after the last dose of gilteritinib
    • ARM D: Males of reproductive potential must agree to use effective contraception during treatment and for at least 4 months after the last dose of gilteritinib
    • NEUROPSYCHOLOGICAL TESTING: Patient must be enrolled on Arm A or Arm B. Patients who transfer to Arm C or Arm D are not eligible
    • NEUROPSYCHOLOGICAL TESTING: Patient must be 5 years or older at the time of enrollment
    • NEUROPSYCHOLOGICAL TESTING: English-, French- or Spanish-speaking
    • NEUROPSYCHOLOGICAL TESTING: No known history of neurodevelopmental disorder prior to diagnosis of AML (e.g., Down syndrome, fragile X, William syndrome, mental retardation)
    • NEUROPSYCHOLOGICAL TESTING: No significant visual or motor impairment that would prevent computer use or recognition of visual test stimuli
    • All patients and/or their parents or legal guardians must sign a written informed consent
    • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.

    Exclusion Criteria:

    • Fanconi anemia
    • Shwachman Diamond syndrome
    • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
    • Telomere disorders
    • Germline predispositions known, or suspected by the treating physician to increase risk of toxicity with AML therapy
    • Any concurrent malignancy
    • Juvenile myelomonocytic leukemia (JMML)
    • Philadelphia chromosome positive AML
    • Mixed phenotype acute leukemia
    • Acute promyelocytic leukemia
    • Acute myeloid leukemia arising from myelodysplasia
    • Therapy-related myeloid neoplasms
    • Patients with persistent cardiac dysfunction prior to enrollment, defined as ejection fraction (EF) < 50% (preferred method Biplane Simpson's EF) or if EF unavailable, shortening fraction (SF) < 24%. *Note: if clinically safe and feasible, repeat echocardiogram is strongly advised in order to confirm cardiac dysfunction following clinical stabilization, particularly if occurring in the setting of sepsis or other transient physiologic stressor. If the repeat echocardiogram demonstrates an EF >= 50%, the patient is eligible to enroll and may receive an anthracycline-containing Induction regimen
    • Administration of prior anti-cancer therapy except as outlined below:
    • Hydroxyurea
    • All-trans retinoic acid (ATRA)
    • Corticosteroids (any route)
    • Intrathecal therapy given at diagnosis
    • In particular, strong inducers of CYP3A4 and/or P-glycoprotein (P-gp) should be avoided from the time of enrollment until it is determined whether the patient will receive gilteritinib. Patients receiving gilteritinib will be required to avoid strong CYP3A4 inducers and/or strong P-gp inducers for the duration of the study treatment
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
    • ARM D: Patient does not have any congenital long QT syndrome or congenital heart block

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Magrolimab versus Placebo in Combination with Venetoclax and Azacitidine in Newly Diagnosed, Previously Untreated Patients with Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy. - NCT05079230

    Primary Objectives: - To compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in patients with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy as measured by complete remission (CR) rate within 6 cycles of treatment. - To compare the efficacy of magrolimab + venetoclax + azacitidine versus placebo + venetoclax + azacitidine in patients with previously untreated AML who are ineligible for intensive chemotherapy as measured by overall survival (OS).

    View All Details
    • Protocol Number:
      022105

    • Principal Investigator:
      Anupama Doraiswamy M.D

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other,Myeloid and Monocytic Leukemia

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Venetoclax (ABT-199) AZACITIDINE(Vidaza) Magrolimab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Anupama Doraiswamy M.D

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

    • Previously untreated individuals with histological confirmation of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria who are ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to age, or comorbidity. Individuals must be considered ineligible for intensive chemotherapy, defined by the following:
    • ≥ 75 years of age; Or
    • ≥ 18 to 74 years of age with at least 1 of the following comorbidities:
    • Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3
    • Diffusing capacity of the lung of carbon monoxide ≤ 65% or forced expiratory volume in 1 second ≤ 65%
    • Left ventricular ejection fraction ≤ 50%
    • Baseline creatinine clearance ≥ 30 mL/min to < 45 mL/min calculated by the Cockcroft Gault formula or measured by 24-hour urine collection
    • Hepatic disorder with total bilirubin > 1.5 x upper limit of normal (ULN)
    • Any other comorbidity that the investigator judges to be incompatible with intensive chemotherapy
    • ECOG performance status:
    • Of 0 to 2 for individuals ≥ 75 years of age Or
    • Of 0 to 3 for individuals ≥ 18 to 74 years of age
    • Individuals with white blood cell (WBC) count ≤ 20 x 10^3/μL prior to randomization. If the individual's WBC is > 20 x10^3/μL prior to randomization, the individual can be enrolled, assuming all other eligibility criteria are met. However, the WBC should be ≤ 20 x 10^3/μL prior to the first dose of study treatment and prior to each magrolimab/placebo dose during Cycle 1.
    • Note: Individuals can be treated with hydroxyurea and/or leukapheresis prior to randomization and throughout the study to reduce the WBC to ≤ 20 x 10^3/μL to enable eligibility for study drug dosing
    • Hemoglobin must be ≥ 9 g/dL prior to initial dose of study treatment
    • Note: Transfusions are allowed to meet hemoglobin eligibility
    • Pretreatment blood cross-match completed

    Key Exclusion Criteria:

    • Prior treatment with any of the following:
    • cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα)-targeting agents
    • Antileukemic therapy for the treatment of AML (eg, hypomethylating agents (HMAs), low-dose cytarabine, and/or venetoclax), excluding hydroxyurea
    • Note: Individuals with prior MDS who have not received prior HMAs or venetoclax or chemotherapeutic agents for MDS may be enrolled in the study. Prior treatment with myelodysplastic syndrome (MDS) therapies including, but not limited to lenalidomide, erythroid-stimulating agents, or similar red blood cell negative (RBC-), white blood cell negative (WBC-), or platelet-direct therapies or growth factors is allowed for these individuals.
    • Clinical suspicion of or documented active central nervous system (CNS) involvement with AML
    • Individuals who have acute promyelocytic leukemia
    • Second malignancy, except MDS, treated basal cell or localized squamous skin carcinomas, localized prostate cancer, or other malignancies for which individuals are not on active anticancer therapies and have had no evidence of active malignancy for at least 1 year Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase I/II Study of Bosutinib in Pediatric Patients with Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph+ Chronic Myeloid Leukemia. - NCT04258943

    Phase 1 Part: 1. To determine the Recommended Phase 2 Dose (RP2D) of bosutinib for R/I (RP2DR/I) and ND chronic phase (RP2DND) pediatric patients with CML, based on the pharmacokinetic, safety and tolerability profile of bosutinib observed at various dose levels in pediatric patients with CML who are resistant or intolerant to prior TKI therapy. 2. To evaluate the overall safety profile during the first cycle of therapy (28 days); 3. To evaluate the safety and tolerability profile during the prolonged exposure to bosutinib; 4. To preliminary evaluate the anti-leukemic activity in pediatric patients with Philadelphia chromosome positive CML following resistance or intolerance to one or more TKIs. 5.To evaluate the effects of bosutinib on growth and bone metabolism; 6.To assess the changes in gastrointestinal symptoms as reported by patients and/or caregivers; 7.To assess the palatability of the bosutinib formulation (taste, texture, ease of swallowing) in patients aged 4-18 years of age. Phase 2 Part: 1.To assess the PK of bosutinib at the RP2DND and RP2DR/I in pediatric patients with ND or R/I Ph + CML. 2.To assess the population PK of bosutinib. 3.To assess the pooled safety and tolerability profile (based on AEs) of bosutinib in pediatric patients with ND and R/I Ph+ CML. 4.To describe the clinical efficacy of bosutinib in pediatric patients with newly diagnosed Ph+ CML in chronic phase; 5.To describe the clinical efficacy of bosutinib in pediatric patients with Ph + CML in any phase of disease following resistance or intolerance to one or more TKIs. 6.To assess other safety parameters of bosutinib 7.To assess the relationship between the PK of bosutinib and key safety and efficacy metrics.

    View All Details
    • Protocol Number:
      112003

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Bosutinib

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Inclusion criteria Phase 1 (R/I patients only)

        1. Cytogenetic and molecular diagnosis of Philadelphia chromosome-positive CML[2] at either time of initial CML diagnosis or at time of study screening: Cytogenetics must be performed by chromosome banding analysis (CBA) of bone marrow cell metaphases, and requires at least 20 metaphases. Only if dividing marrow cells cannot be obtained, or if there is an insufficient number of metaphases, CBA can be substituted by interphase fluorescence in situ hybridization (IFISH) of bone marrow or peripheral blood cells, using dual color dual fusion probes, that allow the detection of BCR-ABL+ nuclei; at least 200 nuclei should be counted. Qualitative RT-PCR should be performed on RNA extracted from freshly collected bone marrow or peripheral blood cells. It identifies the transcript type, either e14a2 or 13a2 (also known as b3a2 and b2a2), or much more rarely e19a2, or e1a2, indicating the BCRABL protein weight (P210, rarely P230 or P190). 2. Resistance (suboptimal response or failure, as defined by 2013 European Leukemia Net guidelines[3]) or intolerance (with or without suboptimal response or failure) to at least one prior tyrosine kinase inhibitor (TKI) The 2013 European LeukemiaNet guidelines[3] will be used to define suboptimal response and failure to prior TKI therapy. Details are provided in appendices 3 (intolerance or failure after one TKI) and 4 (Failure after more than one TKIs). Intolerance to prior TKI therapy will be determined by the treating investigator, but generally applies to patients who are unable to receive standard or reduced doses of a TKI due to significant drug-related toxicity and/or when the drug-related toxicity is not responding to appropriate medical management. Patients who enroll as a result of intolerance to prior TKI therapy may have any level of response to their prior therapy and still be eligible. 3. Age ≥1 and <18 years at day of attaining the informed consent. 4. Lansky performance status ≥50% for patients ≤16 years of age, or Karnofsky scale ≥50% for patients >16 years of age (appendix 5). 5. Adequate bone marrow function: For second-line and third-line CP CML patients: Absolute neutrophil count >1000/mm3 (>1.0 x109/L); Platelets ≥75,000/mm3 (≥75 x109/L) without any platelet transfusions during the preceding 7 days. For fourth-line CP and all for all AP/BP CML patients: Absolute neutrophil count >500/mm3 (>0.5 x109/L); Platelets ≥50,000/mm3 (≥50 x109/L) without any platelet transfusions during the preceding 7 days. 6. Adequate Renal Function: Subjects must have a calculated creatinine clearance (CrCl) ≥ 60mL/min/1.73 m2, using the Schwartz formula to estimate GFR (see appendix 11). 7. Adequate liver function, including: AST/ALT ≤2.5 x upper limit normal (ULN) or ≤5 x ULN if attributable to disease involvement of the liver; Total bilirubin ≤1.5 x ULN unless the patient has documented Gilbert syndrome. 8. Recovered to Grade 0-1, or to baseline, from any acute toxicities of prior chemotherapy, immunotherapy, radiotherapy, differentiation therapy, or biologic therapy, with the exception of alopecia. 9. Able to reliably swallow whole capsules, whole tablets; or drug added to a suitable foodstuff (from capsule contents, added to either apple sauce or yoghurt); or tablets and/or capsules dissolved in water as an oral syringe drinking solution, or tablets dissolved and administered by NG tube when needed. 10. Serum/urine pregnancy test (for all girls ≥ age of menarche) negative at screening. 11. Male and female patients of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active. 12. Written informed consent of parent(s)/legal guardian(s) and/or patients (when applicable depending on age and local law and regulations) 13. Patients (including legally acceptable representative for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion criteria Phase 1 (R/I patients only) Patients presenting with any of the following will not be included in the study: 1. Diagnosis of primary Ph+ acute lymphoblastic leukemia. 2. In patients with AP/BP CML: leptomeningeal leukemia, defined as positive cytology on lumbar puncture (including both CNS2 and CNS3 status), or clinical symptoms or signs present. This assessment is not required for inclusion of CP CML patients. 3. Extramedullary disease only. 4. Documented prior history of T315I or V299L BCR-ABL1 mutations (Note: BCR-ABL1 mutation testing will be performed at screening for a baseline assessment, but results are not used to determine eligibility. This exclusion criterion is based on whether there is a known history of these mutations at the time of study entry. If these mutations become evident during the study the patient will go off study). 5. Any prior treatment with a TKI within 7 days prior to starting bosutinib treatment, or other antitumor or anti-leukemia treatment (with the exception of hydroxyurea and/or anagrelide) within 14 days prior to start of bosutinib treatment. 6. Prior growth factors or biologic agents within 7 days prior to bosutinib treatment. 7. Use of strong or moderate CYP3A4 inhibitors and inducers (see Appendix 8) within 7 days prior and/or concomitant to bosutinib treatment 8. Use of proton pump inhibitors (Ph-modifying agents) within 7 days prior and/or concomitant to bosutinib treatment. 9. Prior radiotherapy within 3 months prior to bosutinib treatment. 10. Allogeneic stem cell transplantation within 3 months prior to bosutinib treatment. 11. Donor lymphocyte infusion (DLI) within 1 month prior to bosutinib treatment. 12. Hereditary bone marrow failure disorder. 13. Graft-versus-host disease (GVHD) within 60 days prior to bosutinib treatment. 14. Major surgery within 14 days prior to bosutinib treatment (recovery from any previous surgery should be complete before day 1). 15. History of clinically significant or uncontrolled cardiac disease, including: History of or active congestive heart failure; Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes); Diagnosed or suspected congenital or acquired prolonged QT syndrome; History of prolonged QTc. 16. Prolonged QTc (>450 msec, average of triplicate ECGs). 17. Need for medications known to prolong the QT interval. 18. Pregnant and/or nursing women 19. Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval. 20. Left ventricular ejection fraction <50% or shortening fraction <28%. 21. Recent or ongoing clinically significant gastrointestinal disorder that may interfere with the intake or absorption of the drug. 22. Evidence of serious active or uncontrolled bacterial, fungal or viral infection. 23. Known history of hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness. 24. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

        Inclusion criteria Phase 2

        • Resistant/Intolerant CML patients: R/I The inclusion criteria for the R/I patients in Phase 2 are identical to the Phase 1 inclusion criteria.
        • Newly Diagnosed CML patients 1. Cytogenetic and molecular diagnosis of Philadelphia chromosome-positive CML at either time of initial CML diagnosis or at time of study screening: Cytogenetics must be performed by chromosome banding analysis (CBA) of bone marrow cell metaphases, and requires at least 20 metaphases. Only if dividing marrow cells cannot be obtained, or if there is an insufficient number of metaphases, CBA can be substituted by interphase fluorescence in situ hybridization (IFISH) of bone marrow or peripheral blood cells, using dual color dual fusion probes, that allow the detection of BCR-ABL+ nuclei; at least 200 nuclei should be counted. Qualitative RT-PCR should be performed on RNA extracted from freshly collected bone marrow or peripheral blood cells. It identifies the transcript type, either e14a2 or e13a2 (also known as b3a2 and b2a2), or much more rarely e19a2, or e1a2, indicating the BCRABL protein weight (P210, rarely P230 or P190). 2. Newly diagnosed CP Ph+ CML of ≤ 6 months (from initial diagnosis) without any previous TKI treatment (with the exception of hydroxyurea and/or anagrelide) for CML. Diagnosis of CP CML will be defined as per Appendix 1. 3. Age ≥1 and <18 years at day of attaining the informed consent. 4. Lansky performance status ≥50% for patients ≤16 years of age, or Karnofsky scale ≥50% for patients >16 years of age (appendix 5). 5. Adequate Renal Function: Subjects must have a calculated creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m2, using the Schwartz formula to estimate GFR (see appendix 11). 6. Adequate liver function, including: AST/ALT ≤2.5 x upper limit normal (ULN) or ≤5 x ULN if attributable to disease involvement of the liver; Total bilirubin ≤1.5 x ULN unless the patient has documented Gilbert syndrome. 7. Able to reliably swallow whole capsules, whole tablets; or drug added to a suitable foodstuff (from capsule contents, added to either apple sauce or yogurt); or tablets and/or capsules dissolved as an oral syringe drinking solution, or tablets dissolved and administered by NG tube when needed. 8. Serum/urine pregnancy test (for all girls ≥ age of menarche) negative at screening. 9. Male and female patients of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the Investigator, he/she is biologically capable of having children and is sexually active. 10. Written informed consent of parent(s)/legal guardian(s) and/or patients (when applicable depending on age and local law and regulations) 11. Patients (including legally acceptable representative for minors where applicable) who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion criteria Phase 2
        • Resistant/Intolerant (R/I) CML patients: The exclusion criteria for the R/I cohort in Phase 2 are identical to the Phase 1 exclusion criteria.
        • Newly Diagnosed CML patients: Patients presenting with any of the following will not be included in the study: 1. Diagnosis of primary Ph+ acute lymphoblastic leukemia. 2. Extramedullary disease only. 3. Documented prior history of T315I or V299L BCR-ABL1 mutations (Note: BCR-ABL1 mutation testing will be performed at screening for a baseline assessment, but results are not used to determine eligibility. This exclusion criterion is based on whether there is a known history of these mutations at the time of study entry. If these mutations become evident during the study the patient will go off study). 4. Any prior treatment with a TKI or other anti-tumor or anti-leukemia treatment (with the exception of hydroxyurea and/or anagrelide) 5. Prior growth factors or biologic agents within 7 days prior to bosutinib treatment. 6. Use of strong or moderate CYP3A4 inhibitors and inducers (see Appendix 8) within 7 days prior and/or concomitant to bosutinib treatment 7. Use of proton pump inhibitors (Ph-modifying agents) within 7 days prior and/or concomitant to bosutinib treatment) 8. Hereditary bone marrow failure disorder. 9. Major surgery within 14 days prior to bosutinib treatment (recovery from any previous surgery should be complete before day 1). 10. History of clinically significant or uncontrolled cardiac disease, including:
        • History of or active congestive heart failure;
        • Clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes);
        • Diagnosed or suspected congenital or acquired prolonged QT syndrome;
        • History of prolonged QTc. 11. Prolonged QTc (>450 msec, average of triplicate ECGs). 12. Need for medications known to prolong the QT interval. 13. Pregnant and/or nursing women 14. Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval. 15. Left ventricular ejection fraction <50% or shortening fraction <28%. 16. Recent or ongoing clinically significant gastrointestinal disorder that may interfere with the intake or absorption of the drug. 17. Evidence of serious active or uncontrolled bacterial, fungal or viral infection. 18. Known history of hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness. 19. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia. - NCT03504644

    Phase 1: To determine the maximum tolerated dose of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL. Safety assessment and toxicity characterization after treatment of venetoclax in combination with liposomal vincristine in patients with relapsed or refractory T-cell and B-cell ALL. Phase 2: To determine the preliminary efficacy of venetoclax in combination with liposomal vincristine to induce CR by day 70 in patients with relapsed or refractory T-cell and B-cell ALL.

    View All Details
    • Protocol Number:
      021808

    • Principal Investigator:
      Dale Schaar M.D,Ph.D

    • Phase:
      Phase I/II

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Venetoclax (ABT-199) VINCRISTINE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Dale Schaar M.D,Ph.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Relapsed or refractory ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology)
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Circulating white blood cell (WBC) count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
    • Patients with WBC count above 20 x 10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Women must not be pregnant or breast-feeding
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): No evidence of isolated extramedullary relapse (i.e., testicular or central nervous system [CNS])
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient must not have Burkitt?s lymphoma/leukemia based on the World Health Organization (WHO) criteria
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days; previously treated CNS disease with documented cleared CSF will be allowed
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea) or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active graft versus host disease (GVHD) prior to enrollment if previous HSCT
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patient cannot have poorly controlled human immunodeficiency virus (HIV), or CD4 < 400; HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients should not have received the following within 7 days prior to the first dose of study drug:
    • Steroid therapy for anti-neoplastic intent;
    • Strong and moderate CYP3A inhibitors;
    • Strong and moderate CYP3A inducers
    • ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Patients must not have grade 3 or higher peripheral neuropathy
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Relapsed or refractory ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology)
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): ECOG performance status 0-2
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Adequate liver function with AST/ALT less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
    • Patients with WBC count above 20 x10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Women must not be pregnant or breast-feeding
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of isolated extramedullary relapse (i.e., testicular or CNS)
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient must not have Burkitt?s lymphoma/leukemia based on the WHO criteria
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days; previously treated CNS disease with documented cleared CSF will be allowed
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors)
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active GVHD prior to enrollment if previous HSCT
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient cannot have poorly controlled HIV, or CD4 < 400; HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients with NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients should not have received the following within 7 days prior to the first dose of study drug:
    • Steroid therapy for anti-neoplastic intent;
    • Strong and moderate CYP3A inhibitors;
    • Strong and moderate CYP3A inducers
    • ELIGIBILITY CRITERIA - PHASE II (ARM D): Patients must not have grade 3 or higher peripheral neuropathy

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • An Open-label, Multi-center Phase I Study to Investigate the Safety and Tolerability of REGN1979, an Anti-CD20 x Anti-CD3 bispecific Monoclonal Antibody, in Patients with CD20+ B-cell Malignancies Previously Treated with CD20 Directed Antibody Therapy. - NCT02290951

    The primary objective of the study is to assess the safety, tolerability, and dose-limiting toxicities (DLTs) of REGN1979 administered intravenously (IV). The secondary objectives of the study are: To characterize the pharmacokinetic (PK) profile of REGN1979 To assess the immunogenicity of REGN1979 To study the preliminary antitumor activity of REGN1979 administered to patients with CD20+ B-cell malignancies (non-Hodgkin s lymphoma [NHL] and chronic lymphocytic leukemia [CLL]) previously treated with anti-CD20 antibody therapy. o Minimal residual disease (MRD) assessments in patients with CLL The exploratory objectives of the study are: To evaluate biomarkers that may correlate with mechanism of action, observed toxicity, and potential anti-tumor activity including, but not limited, to: o Cytokine profiling o Peripheral blood B-cell and T-cell subsets and immune phenotyping o Changes in gene expression in peripheral blood

    View All Details
    • Protocol Number:
      011411

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Lymphoid Leukemia,Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      REGN1979

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Have documented CD20+ B-cell malignancy, with active disease not responsive to prior therapy, for whom no standard of care options exists, and for whom treatment with an anti-CD20 antibody may be appropriate:
    • Part A (IV administration) B-NHL confirmed by National Cancer Institute (NCI) working group criteria
    • Part B (SC administration): Confirmed diagnosis of B-NHL requiring therapy as defined by WHO classification 2017 2. Patients with B-NHL must have had prior treatment with an anti-CD20 antibody therapy. Patients with CLL (Part A only) are not required to have received prior treatment with an anti-CD20 antibody therapy as defined in the protocol.
    • For the inclusion in the disease-specific expansion cohort enrolling DLBCL patients after failure of CAR-T therapy, the patient must have recovered from the toxicities of the lymphodepletion therapy and CAR-T infusion.
    • For inclusion in Part B, patients must have FL grade 1-3a or DLBCL (with or without prior CAR-T) per the criteria above, and:
    • Patients with FL grade 1-3a and DLBCL must have received at least 2 prior lines of systemic therapy, including an anti-CD20 antibody and an alkylating agent 3. All patients must have at least one bi-dimensionally measurable lesion ≥1.5 cm) documented by CT or MRI scan, if CT scan is not feasible. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 5. Life expectancy of at least 6 months 6. Adequate bone marrow function as described in the protocol 7. Adequate organ function as described in the protocol 8. Willingness to undergo mandatory tumor biopsy pretreatment, if in the opinion of the investigator, the patient has an accessible lesion that can be biopsied without significant risk to the patient. 9. Willing and able to comply with clinic visits and study-related procedures 10. Provide signed informed consent or legally acceptable representative

    Key Exclusion Criteria:

      1. Primary central nervous system (CNS) lymphoma or known or suspected CNS involvement by non-primary CNS NHL 2. History of or current relevant CNS pathology such as
    • Epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or
    • Evidence for presence of inflammatory lesions and/or vasculitis on cerebral MRI 3. Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug 4. Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) infection [(as noted by detectable levels on a blood polymerase chain reaction (PCR) assay)]. 1. Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus deoxyribonucleic acid (DNA) that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted upon consultation with the physician managing the infection. 2. Patients who show detectable levels of CMV at screening will need to be treated with appropriate antiviral therapy and demonstrate at least 2 undetectable levels of CMV by PCR assay (at least 7 days apart) before being re-considered for eligibility. 5. Patients who have received a live vaccination within 28 days of first dose of study treatment Note: Other protocol Inclusion/Exclusion criteria apply

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • Characterization of Brain Dysfunction During Development in Survivors of Childhood Acute Lymphoblastic Leukemia.

    1.1 Primary Objective Our primary objective is to delineate effects of being treated for childhood leukemia on the developing brain. To that end, our aims are to: 1.1.1 Provide a complete and quantitative characterization of treatment-related effects of chemotherapy treatment on brain functions with electroencephalography (EEG), using well-established auditory cognitive paradigms (Aim 1), 1.2.1 Identify abnormal patterns of neural connectivity in these patients, using EEG and functional MRI, and advanced functional connectivity modeling (Aim 2), 1.3.1 Assess these pathways, and their changes over time in childhood survivors, as well as their relationship to the development of cognitive skills, at both one year and two years following successful cancer treatment chemotherapy treatment (Aim 3). 1.2 Secondary Objective 1.3.1 To assess cortical maturation among survivors and describe relationships between neurophysiologic endpoints and cognitive abilities as determined by neuropsychological testing.

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    • Protocol Number:
      112002

    • Principal Investigator:
      Peter Cole M.D.

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified

      • Contacts:

      • Rutgers University Prinicipal Investigator: Peter Cole M.D.
    • Rutgers Cancer Institute of New Jersey
  • Exploring Patient and Caregiver Perspectives and Experiences with Financial Toxicity.

    Objectives: Aim 1: To explore patient perspectives on the implementation of FT screening, educational and navigation programming. We will interview a purposive sample of patients to include minority and those at highest risk of FT (12-14 African Americans (AA), 12-14 with low-income/education, 12-14 employed at time of diagnosis, total approximately 40 patients) in NJ. We will aim to understand their experiences related to FT, how this impacts their disease management, and what clinical support has been provided. Aim 2: To understand caregiver experiences of financial toxicity viewing FT as a family problem. We will interview a purposive group of heme-onc patient caregivers (12-14 AA, 12-14 low-income/education, total approximately 20-30 caregivers) in NJ. Caregiver interviews will elicit the changes that occurred within the family system to accommodate the changes in the families financial reality and explore potential clinical interventions that could mitigate these impacts. Aim 3: To identify organizational and community level barriers to implementation of financial navigation in cancer centers. We will purposively sample key stakeholders (n=8-10 physicians, nurses, social workers, pharmacists and administrators) in CINJ and RWJBH clinical operations to engage them in a discussion to reflect on our findings from Aim 1 & 2 and to identify key barriers/facilitators to inform implementation strategy recommendations to be tested in the next phase of our research. This iterative process involving stakeholders will help us develop a targeted FT navigation program.

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    • Protocol Number:
      132105

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Hodgkin's Lymphoma,Leukemia, other,Myeloid and Monocytic Leukemia,Leukemia, not otherwise specified

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D
    • Rutgers Cancer Institute of New Jersey
  • Improving Chemotherapy-Induced Nausea Control Through Bright Ideas?-CIN Training: A Feasibility Study in Children Receiving Oral Chemotherapy. - NCT04929899

    Primary Objective: To determine the feasibility of a future trial comparing chemotherapy-induced nausea (CIN) control in children with acute lymphoblastic leukemia (ALL) receiving oral 6-mercaptopurine who do and do not receive problem-solving skills training. Secondary Objectives: 1) To describe the incidence of CIN and chemotherapy-induced vomiting (CIV) in children receiving oral 6-mercaptopurine for treatment of ALL in maintenance in children participating in Phase 1 and Phase 2. 2) To explore possible risk factors for CIN and CIV in children participating in Phase 1 including demographic factors, history of motion sickness, past CIV control, nudix hydrolase 15 (NUDT15) genotype and thiopurine methyltransferase (TPMT) genotype. 3) To describe strategies to control CIN explored by children and guardians 4) To explore age-based differences in responses to and satisfaction with Bright IDEAS.

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    • Protocol Number:
      132104

    • Principal Investigator:
      Katie Devine

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, not otherwise specified,Leukemia, other

      • Contacts:

      • Rutgers University Prinicipal Investigator: Katie Devine

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Age: ≥ 4 years (PeNAT validated in patients 4 to 18 yrs)
    • newly diagnosed or recurrent disease: first diagnosis of ALL (i.e. non-relapsed) in maintenance therapy
    • English, French or Spanish-speaking with an English, French or Spanish-speaking guardian (PeNAT available in these languages)
    • without physical or cognitive impairments that preclude use of the PeNAT
    • planned to receive PO 6-mercaptopurine
    • not planned to receive IV, IM, SC or IT chemotherapy or oral or IV corticosteroids during the 7-day study period

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Rutgers Cancer Institute of New Jersey
  • International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones. - NCT03007147

    Primary Aim: To compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. Secondary Aims: -To determine the feasibility of administration of imatinib after allogeneic HSCT in High Risk (HR) Ph+ ALL patients. -To determine event-free survival (EFS) of High Risk pediatric Ph+ ALL patients treated with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib. -To compare rates of Grade 3 or higher infections in SR Ph+ ALL patients between the two randomized arms. -To evaluate EFS and overall survival (OS) of all enrolled participants. To evaluate OS in SR patients. To evaluate OS in HR patients.

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    • Protocol Number:
      111804

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Any Site,Leukemia, other

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      IMATINIB MESYLATE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Richard Drachtman M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Diagnostic samples will be collected and analyzed according to the procedures of the National front-line protocol
    • Patients should be enrolled on National ALL protocol prior to enrollment on EsPhALL2017/COGAALL1631. Regardless of initial front-line protocol baseline diagnostic samples must be available to develop an MRD probe
    • BCR-ABL1 fusion (Ph+): newly diagnosed ALL (B-ALL or T-ALL) or mixed phenotypic acute leukemia (MPAL meeting 2016 World Health Organization [WHO] definition) with definitive evidence of BCR-ABL1 fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse transcriptase (RT)-PCR
    • ABL-class fusion: newly diagnosed B-ALL with definitive evidence of ABL-class fusions identified according to National/Center procedures of each participating country. ABL-class fusions are defined as those involving the following genes: ABL1, ABL2, CSF1R, PDGFRB, PDGFRA, LYN. Methods of detection include fluorescence in-situ hybridization (FISH, e.g. using break-apart or colocalization signals probes), multiplex or singleplex reverse-transcription polymerase chain reaction (RT-PCR), whole transcriptome or panel-based ribonucleic acid (RNA)-sequencing
    • Regardless of initial front-line protocol, laboratory reports detailing evidence of BCR-ABL1 or ABL-class fusion must be available for the National Trial Unit
    • Ph+ ALL patients must have previously started induction therapy, which includes vincristine, a corticosteroid, usually PEG-L-asparaginase, with or without anthracycline, and/or other standard cytotoxic chemotherapy
    • Ph+ ALL patients have not received more than 14 days of multiagent induction therapy beginning with the first dose of vincristine
    • Ph+ ALL patients may have started imatinib prior to study entry but have not received more than 14 days of imatinib
    • ABL-class fusion patients must have previously completed the 4 or 5 weeks of multiagent Induction chemotherapy
    • ABL-class fusion patients may have started imatinib during Induction IA, at the same time of or after the first vincristine dose
    • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2
    • Direct bilirubin =< 2.0 mg/dL
    • Shortening fraction of >= 27% by echocardiogram
    • Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
    • Corrected QT interval, QTc < 480 msec
    • Note: Repeat echocardiogram and electrocardiogram are not required if they were performed at or after initial ALL diagnosis, before study enrollment
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or serum creatinine within normal limits based on age/gender, as follows:
    • 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
    • 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
    • 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
    • 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
    • 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
    • >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)

    Exclusion Criteria:

    • Known history of chronic myelogenous leukemia (CML)
    • ALL developing after a previous cancer treated with cytotoxic chemotherapy
    • Active, uncontrolled infection, or active systemic illness that requires ongoing vasopressor support or mechanical ventilation
    • Down syndrome
    • Pregnancy and breast feeding
    • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs; a pregnancy test is required for female patients of childbearing potential
    • Lactating females who plan to breastfeed their infants
    • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of treatment according to protocol
    • Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart block
    • Prior treatment with dasatinib, or any TKI inhibitor other than imatinib
    • All patients and/or their parents or legal guardians must sign a written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey
  • Leukemia Inhibitory Factor Levels after Allogeneic Transplantation.

    The primary objective is to determine LIF levels in blood at various times during the transplant process.

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    • Protocol Number:
      022104

    • Principal Investigator:
      Roger Strair M.D., Ph.D.

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Leukemia, other,Leukemia, not otherwise specified

      • Contacts:

      • Rutgers University Prinicipal Investigator: Roger Strair M.D., Ph.D.
    • Rutgers Cancer Institute of New Jersey
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