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  • 16-001: Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents. - NCT03020030

    To test a novel risk group classification scheme with the goal of reducing rates of treatment-related toxicity without compromising complete remission rates and overall event-free survival. a. To test whether remission induction can be de-intensified in low-risk B-ALL patients without adversely impacting complete remission rates or proportion of patients classified as very high risk on the basis of high minimal residual disease (MRD levels). b. To determine rates of event-free survival, disease-free survival and overall survival associated with novel risk group classification scheme.

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    • Protocol Number:
      111805

    • Principal Investigator:
      Peter Cole M.D.

    • Phase:
      Phase III

    • Scope:
      National

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Peter Cole M.D.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Confirmed diagnosis of acute lymphoblastic leukemia. Diagnosis should be made by bone marrow aspirate or biopsy demonstrating ≥ 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype.
    • - For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study. Bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy. 2. Prior Therapy: No prior therapy is allowed except for the following:
    • Corticosteroids: Short courses of corticosteroid (defined as ≤ 7 days of corticosteroids within the 4-weeks preceding registration) are allowed prior to registration.
    • -- Participants who have been on corticosteroids chronically (defined as more than 7 days of corticosteroids within the 4-weeks preceding registration or more than 28 days of corticosteroids over the preceding 6 months) are not eligible.
    • IT cytarabine: A single dose of intrathecal cytarabine (at the time of the diagnostic lumbar puncture) is allowed prior to registration. If patient has received IT cytarabine prior to registration, Day 1 IT cytarabine should not be administered.
    • Emergent Radiation Therapy: Emergent radiation to the mediastinum or other life-threatening masses is allowed prior to registration. 3. Age: 365 days to < 22 years 4. Direct bilirubin < 1.4 mg/dL (23.9 micromoles/L). 5. Ability of parent or guardian to understand and the willingness to sign a written informed consent document.

    Exclusion Criteria:

      1. Mature B-cell (Burkitt's) ALL (defined by the presence of surface immunoglobulin and/or the t(8;14)(q24;q32), t(8;22), or t(2;8) translocation and/or c-myc-gene rearrangement). 2. World Health Organization diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage 3. Any chemotherapy or radiotherapy for previous malignancy are not eligible. 4. Treatment in past with any anti-neoplastic agent, including methotrexate, 6-mercaptopurine, 6-thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (eg, rheumatologic or autoimmune condition). 5. Currently receiving any investigational agents. 6. Known HIV-positivity 7. Uncontrolled intercurrent illness including, but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (eg, with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding, or psychiatric illness/social situations that would limit compliance with study requirements. 8. Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic and/or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled. 9. History of a previous malignancy. Exception: Individuals with a previous malignancy treated with surgery only (no chemotherapy or radiotherapy) more than 5 years prior to registration may be enrolled.

    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 1 Study of TJ011133 Administered Alone or in Combination with Pembrolizumab or Rituximab in Subjects with Relapsed/Refractory Advanced Solid Tumors and Lymphoma. - NCT03934814

    The primary objectives of the study are: 1. to evaluate the tolerability and safety of TJ011133 administered alone in subjects with advanced, relapsed or refractory solid tumors or lymphoma; 2. to evaluate the tolerability and safety of TJ011133 administered in combination with pembrolizumab or rituximab in subjects with advanced, relapsed or refractory solid tumors or lymphoma; 3. to determine the maximum tolerated dose (MTD) of TJ011133 administered alone, administered in combination with pembrolizumab, and administered in combination with rituximab; 4. to evaluate the recommended Phase 2 dose (RP2D) of TJ011133 administered alone, administered in combination with pembrolizumab, and administered in combination with rituximab. The secondary objectives of the study are: 1. to characterize the pharmacokinetic (PK) and pharmacodynamic profiles of TJ011133 administered alone and in combination with pembrolizumab or rituximab; 2. to assess the preliminary anti-tumor activity of TJ011133 alone or in combination with pembrolizumab or rituximab, as measured by best overall response (BOR), objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) (assessed based on Response Evaluation Criteria in Solid Tumors [RECIST 1.1] and immune RECIST [iRECIST] guidelines for response criteria for use in trials testing immunotherapeutics for solid tumors and Lugano criteria and lymphoma response to immunomodulatory therapy criteria [LYRIC] for lymphoma); 3. to evaluate the immunogenicity of TJ011133 administered alone or in combination with pembrolizumab or rituximab; 4. to evaluate the immunogenicity of pembrolizumab or rituximab when administered in combination with TJ011133.

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    • Protocol Number:
      012008

    • Principal Investigator:
      Kevin David M.D

    • Phase:
      Phase I

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      TJ011133 RITUXIMAB MK-3475 (Pembrolizumab)

      • Contacts:

      • Rutgers University Prinicipal Investigator: Kevin David M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma.
    • Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.
    • Part 2 with Pembrolizumab: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (RECIST) 1.1, and available fresh metastatic biopsy prior to study entry.
    • All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions.

    Exclusion Criteria:

    • Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.
    • Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
    • Participants with mantle cell lymphoma.
    • Impaired cardiac function or clinically significant cardiac diseases.
    • Prior treatment with CD47 or SIRPα inhibitors.
    • Prior autologous stem cell transplant <=3 months prior to starting study.
    • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
    • Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy.
    • History of autoimmune anemia or autoimmune thrombocytopenia.
    • Positive Direct Antiglobulin Test.
    • Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.

    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 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.

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    • 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 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis - NCT04279847

    Primary Objective: To assess the safety and tolerability of INCB057643 as monotherapy in participants with relapsed or refractory myelofibrosis who have received at least 1 line of prior therapy including ruxolitinib and have no further available therapy known to provide clinical benefit, and with risk category of intermediate-2 or high according to DIPSS. Secondary Objectives: 1. To evaluate anemia response in participants treated with INCB057643 as monotherapy. 2. To evaluate RBC transfusion dependency. 3. To evaluate spleen volume in participants treated with INCB057643 as monotherapy. 4. To evaluate rate of spleen response in participants treated with INCB057643 as monotherapy. 5. To evaluate duration of spleen response in participants treated with INCB057643 as monotherapy. 6. To evaluate impact on quality of life of INCB057643 when administered monotherapy.

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    • Protocol Number:
      022001

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

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Chemotherapy single agent systemic Chemotherapy multiple agents systemic

    • Drugs Involved:
      Ruxolitinib INCB057643

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Relapsed or refractory primary myelofibrosis (MF), secondary MFs (post-polycythemia vera MF, post- essential thrombocythemia MF) myeloproliferative neoplasm (MPN), myelodysplastic syndrome (MDS), and myelodysplastic/myeloproliferative neoplasm overlap syndrome (MDS/MPN)
    • Must not be a candidate for potentially curative therapy, including hematopoietic stem-cell transplantation.
    • Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate at screening/baseline, or archival sample obtained since completion of most recent therapy.
    • Willingness to avoid pregnancy or fathering children.

    Exclusion Criteria:

    • Prior receipt of a BET inhibitor within 5 half-lives of the compound, and/or experienced BET inhibitor-related AE(s) resulting in dose discontinuation.
    • Receipt of anticancer medications or investigational drugs within the protocol-defined interval before the first dose of study treatment: Note: For participants in Part 2, Treatment Group B, ruxolitinib will continue at the participants' current, ongoing doses. No ruxolitinib washout is needed.

    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 Open-Label Study of Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Older Patients or Patients with Significant Comorbidities Ineligible for Standard Chemotherapy. - NCT01716806

    Primary: To assess the objective response rates (ORR) of single-agent brentuximab vedotin and brentuximab vedotin in combination with other agents as frontline therapy in patients age > 60 years and in patients ineligible for conventional combination chemotherapy due to comorbidities. Secondary: (1). To evaluate safety and tolerability of single-agent brentuximab vedotin and the safety of brentuximab vedotin when given in combination with other agents (2). To assess duration of response (3). To assess complete remission (CR) rate (4). To assess progression-free survival (PFS) (5). To assess resolution of B symptoms (6). To assess pharmacokinetics and immunogenicity of brentuximab vedotin (all parts) and nivolumab (Part D only) (7). To assess overall survival (OS) (Parts E and F only)

    View All Details
    • Protocol Number:
      011916

    • Principal Investigator:
      Andrew Evens M.D

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Brentuximab vedotin

      • Contacts:

      • Rutgers University Prinicipal Investigator: Andrew Evens M.D

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Parts A, B, C, and D: 60 years of age or older
    • Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
    • Treatment-naive patients with CD30-expressing PTCL (Part F)
    • Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
    • Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
    • A CIRS score of 10 or greater
    • Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
    • Measurable disease of at least 1.5 cm as documented by radiographic technique
    • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)

    Exclusion Criteria:

    • Symptomatic neurologic disease compromising IADLs or requiring medication
    • History of progressive multifocal leukoencephalopathy
    • Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
    • Concurrent use of other investigational agents
    • Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
    • History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
    • Part D only:
    • Received any prior immune-oncology therapy
    • History of known or suspected autoimmune disease
    • Prior allogeneic stem cell transplant
    • History of cerebral vascular event within 6 months of first dose of study drug
    • Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
    • Known history of pancreatitis
    • Parts D, E, and F only:
    • Known cerebral/meningeal disease related to the underlying malignancy
    • Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment

    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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Rutgers Cancer Institute of New Jersey
  • A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma. - NCT04133636

    To evaluate the overall minimal residual disease (MRD) negative rate of subjects who receive JNJ-68284528.

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    • Protocol Number:
      011909

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Drugs Involved:
      JNJ-68284528

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Cohort A: Received a minimum of 1 to a maximum of 3 prior lines of therapy including a proteasome inhibitor (PI) and immunomodulatory therapy (IMiD), and lenalidomide refractory per International Myeloma Working Group (IMWG) guidelines
    • Cohort B: Received one line of prior therapy including a PI and an IMiD, and disease progression per IMWG criteria less than or equal to (<=) 12 months after treatment with autologous stem cell transplantation (ASCT) or <=12 months from the start of anti-myeloma therapy for participants who have not had an ASCT
    • Cohort C: Previously treated with a PI, an IMiD, an anti-CD38 monoclonal antibody and B-cell maturation antigen (BCMA)-directed therapy
    • Cohort D: Newly diagnosed multiple myeloma per IMWG with a history of 4 to 8 total cycles of initial therapy, including induction, high-dose therapy, and ASCT with or without consolidation
    • Cohort E: Have newly diagnosed multiple myeloma without prior therapy (one cycle of prior therapy before enrollment is acceptable) and classified as high risk defined as either: 1) International Staging System (ISS) stage III criteria, Beta 2 microglobulin greater than or equal to (>=) 5.5 milligram per liter (mg/L) (via local or central laboratory assessment) or 2) high risk cytogenetic features del(17/17p), t (14;16), t(14;20), 1q amplification (at least 4 total copies) in at least 20 percent (%) of the total plasma cell population
    • Cohort F:
    • Participant must have a documented efficacy response of very good partial response (VGPR) or better, without progressive disease prior to enrollment, as assessed per IMWG 2016 criteria
    • Received 4 to 8 cycles of initial therapy as specified below. The dose/schedule of cycles administered will be as per standard of care. Up to 1 cycle of the regimens specified may not include one agent listed (example, held due to toxicity), acceptable combinations include: at least 5 to 8 cycles of initial therapy with daratumumab, bortezomib, lenalidomide and dexamethasone (D-VRd). The dose/schedule of cycles administered will be as per standard of care or; daratumumab, lenalidomide and dexamethasone (D-Rd) or; a carfilzomib-based triplet or quadruplet regimen
    • Cohorts A, B, C, E:
    • Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram (mg)/24 hours
    • Light chain multiple myeloma in whom only measurable disease is by serum free light chain (FLC) levels in the serum: Serum immunoglobulin FLC >=10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
    • Cohort A: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole -body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria. A minimum of one lesion with a bi-dimensional measurement of at least 1 centimeter (cm)*1 cm is required
    • Cohorts B, C: For participants with neither serum nor urine measurable disease, baseline positron emission tomography/ computed tomography (PET/CT) or whole body magnetic resonance imaging (MRI) may be used to satisfy the measurable disease criteria
    • Cohorts A, B, C, D, E, F: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

    Exclusion Criteria:

    • Cohorts A, B, D, F: Any therapy that is targeted to BCMA
    • Cohorts A, B, C, D, F: Prior treatment with chimeric antigen receptor T (CAR-T) therapy directed at any target
    • Cohorts A, B, C, D, F:
    • Ongoing toxicity from previous anticancer therapy must resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy
    • Received a cumulative dose of corticosteroids equivalent to >=70 mg of prednisone within the 7 days (Cohort A, B, C, F) or 14 days (Cohort D) prior to apheresis
    • Serious underlying medical condition, such as (a) evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection; (b) active autoimmune disease or a history of autoimmune disease within 3 years; (c) overt clinical evidence of dementia or altered mental status; (d) any history of Parkinson's disease or other neurodegenerative disorder
    • Cohorts A, B, C, D, E, F: Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma

    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, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] with MK-3475 [Pembrolizumab] Coformulation) in Participants with Relapsed or Refractory Hematological Malignancies - NCT05005442

    Primary Objective: To determine the safety and tolerability of MK-7684A (Cohorts A to F). Secondary Objective: To evaluate ORR following administration of MK-7684A (Cohorts A to F) per disease-specific criteria as assessed by Investigator To evaluate the DOR following administration of MK-7684A (Cohorts A to F) To evaluate the DCR following administration of MK-7684A (Cohorts A to F) To characterize the PK profile of vibostolimab (Cohorts A to F)

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    • Protocol Number:
      012109

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma,Multiple Myeloma,Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM). For PMBCL, DLBCL, FL, and MM:
    • Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it. For DLBCL and NHL:
    • Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease. For NHL:
    • Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy. All participants:
    • Have measurable disease.
    • Have adequate organ function.
    • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
    • Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
    • Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.

    Exclusion Criteria

      For DLBCL and NHL:
    • Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms. For MM:
    • Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
    • Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
    • Has known prior or current central nervous system (CNS) involvement. For Epstein Barr virus (EBV) positive DLBCL:
    • Associated with a solid organ transplant. For all participants:
    • A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
    • Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
    • Has a history of a second malignancy.
    • Any PMBCL participants that require the use of urgent cytoreductive therapy.
    • If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
    • Has received prior radiotherapy within 2 weeks of start of study intervention.
    • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
    • Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
    • Has a known history of Human Immunodeficiency Virus (HIV) infection.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years.
    • Has an active infection requiring systemic therapy.
    • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
    • Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
    • Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
    • Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.

    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, Open-Label, Dose-Escalation, Multicenter Study To Evaluate The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Efficacy Of Subcutaneous Glofitamab Following Obinutuzumab Pretreatment In Patients With Relapsed Or Refractory B-Cell Non-Hodgkin Lymphoma. - NCT04077723

    Primary Objective: To evaluate the safety and tolerability of glofitamab SC administration. Secondary: 1. To characterize the PK profile of glofitamab SC administration. 2. To evaluate the preliminary efficacy of glofitamab given subcutaneously followed by IV and/or SC administration. 3. To evaluate potential effects of ADAs. 4. To evaluate the relationship between glofitamab exposure and pharmacodynamic biomarkers. 5. To evaluate the preliminary efficacy of tocilizumab in ameliorating the symptoms of severe CRS following glofitamab treatment.

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    • Protocol Number:
      012107

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Gazyva (obinutuzumab) Tocilizumab Glofitamab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Depending upon study part: a history or status of a histologically-confirmed hematological malignancy that is expected to express CD19 and CD20; relapse after or failure to respond to at least two prior treatment regimens; and no available treatment options that are expected to prolong survival
    • Must have at least one measureable target lesion (>/= 1.5 cm) in its largest dimension by computed tomography scan
    • Able and willing to provide a fresh biopsy from a safely accessible site, per Investigator's determination, providing the participant has more than one measurable target lesion
    • Eastern Cooperative Oncology Group performance status of 0 or 1
    • Life expectancy of >/= 12 weeks
    • Adverse events from prior anti-cancer therapy must have resolved to Grade
    • Adequate liver, haematological, and renal function
    • Negative test results for acute or chronic hepatitis B virus infection
    • Negative test results for hepatitis C virus and HIV
    • The contraception and abstinence requirements are intended to prevent exposure of an embryo to the study treatment. The reliability of sexual abstinence for male and/or female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing drug exposure
    • Female participants: A female participant is eligible to participate if she is not pregnant and not breastfeeding, and if at least one of the following applies: women of non-childbearing potential (WONCBP); women of child bearing potential (WOCBP) who agree to remain abstinent or use two highly effective contraceptive methods with a failure rate of <1% per year during the treatment period and for at least 18 months after obinutuzumab or 3.5 months after the last dose of RO7227166, 2 months after last dose of glofitamab, or 3 months after the last dose of tocilizumab, whichever is longer. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal occlusion/ ligation, male sexual partner who is sterilized, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method; have a negative pregnancy test (blood) within the 7 days prior to the first study treatment administration
    • Male participants: During the treatment period and for at least 3 months after obinutuzumab, or 3.5 months after the last dose of RO7227166, 2 months after the last dose of glofitamab, or 2 months after the last dose of tocilizumab whichever is longer, agreement to: Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year, with a partner who is a women of childbearing potential. With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo; refrain from donating sperm during this same period

    Exclusion Criteria:

    • Circulating lymphoma cells, defined by out of range (high) absolute lymphocyte count or the presence of abnormal cells in the peripheral blood differential signifying circulating lymphoma cells
    • Participants with acute bacterial, viral, or fungal infection at baseline, confirmed by a positive blood culture within 72 hours prior to obinutuzumab infusion or by clinical judgment in the absence of a positive blood culture
    • Participants with known active infection, or reactivation of a latent infection, whether bacterial, viral fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics
    • Pregnant or breast-feeding or intending to become pregnant during the study
    • Prior treatment with systemic immunotherapeutic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines or monoclonal antibodies within 4 weeks or five half-lives of the drug, whichever is shorter, before obinutuzumab infusion on D-7
    • History of treatment-emergent immune-related AEs associated with prior immunotherapeutic agents and auto-immune disease
    • Treatment with standard radiotherapy, any chemotherapeutic agent, or treatment with any other investigational or approved anti-cancer agent within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to obinutuzumab infusion
    • Prior solid organ transplantation
    • Prior allogeneic stem cell transplant (SCT) and prior chimeric antigen receptor
    • T-cell therapy
    • Autologous SCT within 100 days prior to obinutuzumab infusion
    • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy and confirmed progressive multifocal leukoencephalopathy
    • Current or past history of central nervous system (CNS) lymphoma and CNS disease
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
    • Major surgery or significant traumatic injury < 28 days prior to the Gpt infusion or anticipation of the need for major surgery during study treatment
    • Participants with another invasive malignancy in the last 2 years
    • Significant cardiovascular disease
    • Administration of a live, attenuated vaccine within 4 weeks before Gpt infusion or anticipation that such a live attenuated vaccine will be required during the study
    • Received systemic immunosuppressive medications (including but not limited to cyclohosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment <=25 mg/day of prednisone or equivalent, however there must be documentation that the participant was on a stable dose of at least a 2-week duration prior to Gpt infusion. Inhaled and topical steriods are permitted

    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 III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma. - NCT04408638

    Primary Objective: Overall survival (OS), defined as the time from randomization to date of death from any cause. Secondary Objectives: 1. Progression-free survival (PFS), defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the Independent Review Committee (IRC). 2. PFS, defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined by the investigator. 3. Complete response (CR) rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the IRC. 4. CR rate, defined as the proportion of patients whose best overall response is a CR on positron emission tomography/computed tomography (PET/CT) during the study, as determined by the investigator. 5. Objective response rate (ORR), defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the IRC. 6. ORR, defined as the proportion of patients whose best overall response is a partial response (PR) or a CR during the study, as determined by the investigator. 7. Duration of objective response (DOR), defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression, or death from any cause, whichever occurs first. 8. Duration of CR, defined as the time from the first occurrence of a documented CR to disease progression, or death from any cause, whichever occurs first. 9. Time to deterioration in physical functioning and fatigue, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire(EORTC QLQ-C30) and in lymphoma symptoms, as measured by the Functional Assessment of Cancer Therapy-Lymphoma subscale (FACT-Lym LymS).

    View All Details
    • Protocol Number:
      012007

    • Principal Investigator:
      Rajat Bannerji Dr.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Drugs Involved:
      GEMCITABINE OXALIPLATIN RITUXIMAB Glofitamab Tocilizumab

      • Contacts:

      • Rutgers University Prinicipal Investigator: Rajat Bannerji Dr.

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria

    • Histologically confirmed diffuse large B-cell lymphoma (DLBCL), not otherwise specified
    • Relapsed/refractory (R/R) disease, defined as follows: Relapsed = disease that has recurred ≥6 months after completion of the last line of therapy; Refractory = disease that either progressed during the last line of therapy or progressed within 6 months (<6 months) of the last line of prior therapy
    • At least one (≥1) line of prior systemic therapy
    • Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, as defined by the study protocol
    • Confirmed availability of tumor tissue, unless unobtainable per investigator assessment. Freshly collected biopsy is preferred. Archival tissue is acceptable
    • At least one bi-dimensionally measurable (≥1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥1 cm) extranodal lesion, as measured on computed tomography (CT) scan
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
    • Adequate hematologic function (unless attributable to the underlying disease, as established by extensive bone marrow involvement or associated with hypersplenism secondary to the involvement of the spleen by DLBCL per the investigator), as defined by the study protocol
    • Adequate renal function, defined as an estimated creatinine clearance ≥30 mL/min

    Exclusion Criteria

    • Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation
    • History of transformation of indolent disease to DLBCL
    • High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma not otherwise specified, as defined by 2016 WHO guidelines
    • Primary mediastinal B-cell lymphoma
    • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
    • Contraindication to obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab
    • Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
    • Peripheral neuropathy assessed to be Grade >1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrollment
    • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment
    • Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment
    • Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment or history of CNS lymphoma
    • Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment
    • Suspected or latent tuberculosis
    • Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
    • Known or suspected chronic active Epstein-Barr viral infection
    • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
    • Known history of progressive multifocal leukoencephalopathy
    • Adverse events from prior anti-cancer therapy not resolved to Grade 1 or better (with the exception of alopecia and anorexia)
    • Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
    • Prior solid organ transplantation
    • Prior allogeneic stem cell transplant
    • Active autoimmune disease requiring treatment
    • Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 4 weeks prior to first dose of study treatment
    • Corticosteroid therapy within 2 weeks prior to first dose of study treatment (exceptions defined by study protocol)
    • Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
    • Clinically significant history of cirrhotic liver disease

    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 Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant. - NCT03901963

    Primary Objective: To evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-CD38 treatment naive patients with newly diagnosed multiple myeloma who are MRD positive as determined by next generation flow (NGF) or next generation sequencing (NGS) following high-dose therapy (HDT) and autologous stem cell transplant (ASCT), with or without consolidation therapy. Secondary Objective: To further evaluate the efficacy, health-related quality of life, and safety of daratumumab in combination with lenalidomide as maintenance treatment for patients with newly diagnosed multiple myeloma.

    View All Details
    • Protocol Number:
      011912

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Multiple Myeloma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Daratumumab LENALIDOMIDE

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Must have newly diagnosed multiple myeloma with a history of a minimum of 4 cycles of induction therapy, have received high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) within 12 months of the start of induction therapy, and be within 6 months of ASCT on the date of randomization
    • Must have a very good partial response (VGPR) or better response assessed per International Myeloma Working Group (IMWG) 2016 criteria at the time of randomization
    • Must have archived bone marrow samples collected before induction treatment (that is, at diagnosis) or before transplant (for example, at the end of induction) or have existing results on the index multiple myeloma clone based on Adaptive Biotechnologies' next generation sequencing (NGS)-based minimal residual disease (MRD) assay. Archived bone marrow samples will be used for calibration of myeloma clonal cells to facilitate assessment of primary end point by NGS. If an existing result on index myeloma clone is available from Adaptive Biotechnologies' NGS-based MRD assay, as part of institutional procedures, an archived bone marrow sample is not required as long as Adaptive Biotechnologies is able to retrieve historical results on the index myeloma clone form the clinical database. Any one of the following archived samples are required: (a) Greater than 1 milliliter (mL) viable frozen bone marrow aspirated aliquot (preferred) collected in an ethylenediaminetetra-acetic acid (EDTA) tube, frozen, and stored at a temperature of -80 centigrade (°C), or; (b) Non-decalcified diagnostic bone marrow aspirate clot sections (block or slides) for MRD assessment: (i) A formalin fixed paraffin embedded (FFPE) block of bone marrow aspirate clot, or slides (preferably 5, if available), 5 micrometer each, of non-decalcified bone marrow, or; (ii) Slides (preferably 5, if available), bone marrow aspirate smear; (iii) Please note, bone marrow core sections are not acceptable samples for analysis; (iv) In exceptional circumstances when index myeloma clone cannot be identified from the archived bone marrow sample, a post-transplant sample can be used to identify myeloma clone with permission from the sponsor
    • Must have residual disease as defined by detectable MRD (Adaptive Biotechnologies' NGS based MRD assay)
    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

    Exclusion Criteria:

    • A history of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease before the of date of randomization. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years
    • Must not have progressed on multiple myeloma (MM) therapy at any time prior to screening
    • Have had prior treatment/therapy with: (a) Daratumumab or any other anti-cluster of differentiation 38 (CD38) therapies, (b) Focal radiation therapy within 14 days prior to randomization with the exception of palliative radiotherapy for symptomatic management but not on measurable extramedullary plasmacytoma. Radiotherapy within 14 days prior to randomization on measurable extramedullary plasmacytoma is not permitted even in the setting of palliation for symptomatic management, or (c) Plasmapheresis within 28 days of randomization
    • Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma
    • Have known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) less than (<) 50 percent (%) of predicted normal
    • Have known moderate or severe persistent asthma within the past 2 years or current uncontrolled asthma of any classification
    • Have any of the following: (a) Known history of seropositivity for human immunodeficiency virus (HIV); (b) Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. Participants with resolved infection (that is, participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR; (c) Seropositive for hepatitis C (anti-hepatitis C virus [HCV] antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response, defined as aviremia at least 12 weeks after completion of antiviral therapy)

    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 Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS Maintenance Monotherapy Compared to Investigator's Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy. - NCT04229979

    The primary objective of the trial is to compare the efficacy of GPS to Investigator's choice of BAT on OS in subjects with AML who are in CR2/CRp2. Secondary Objectives: 1. To assess the safety & tolerability of GPS as measured by clinical reporting of adverse events,findings on physical exam and laboratory parameters in subjects with AML who are in CR2/CRp2. 2. To evaluate the efficacy of GPS compared to Investigator's choice of BAT, in subjects with AML who are in CR2/CRp2, with respect to:Leukemia Free Survival (LFS; OS rate (%) at 6, 9 and 12 months (landmark); LFS rate (%) at 6, 9, and 12 months (landmark; Minimal residual disease by multigene assay (in both peripheral blood and bone marrow aspirates).

    View All Details
    • Protocol Number:
      022003

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

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      Montanide Sargramostim (GM-CSF) Galinpepimut-S (GPS)

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Willing and able to understand and provide signed informed consent for the study that fulfills Institution Review Board (IRB) guidelines
    • Male or female patients > 18 years of age on the day of signing informed consent
    • Must have a diagnosis of AML according to the WHO criteria (primary/de novo or secondary, including treatment-related [e.g., due to prior anthracycline use], as well as cases due to progression of antecedent hematological disorder [e.g., MDS, MPN, or MDS/MPN 'overlap' syndrome).
    • Must be in second morphological complete remission (with or without platelet recovery; CR2/CR2p) for relapsed (but not refractory AML) based upon the International Working Group (IWG) 2003 criteria as follows:
    • <5% myeloblasts in bone marrow.
    • Absence of circulating peripheral blasts.
    • Peripheral blood absolute neutrophil count (ANC) >1000 cells/µL. d. Peripheral blood platelet count >60,000/µL
    • absence of extramedullary disease.
    • Leukemic blasts must express WT1
    • Free of any requirement for red blood cell transfusions.
    • Are not candidates at the time of study entry for allogeneic stem cell transplant (Allo-SCT) due to intercurrent medical conditions or lack of an available donor.
    • Received the last dose of antileukemic therapy at least 3 months prior to study enrolment.
    • Must be within 3 months of having achieved CR2/CR2p
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    • Estimated life expectancy >6 months.
    • If female, is postmenopausal (at least 12 sequential months of amenorrhea) or surgically sterile.
    • Females of childbearing potential must have a negative pregnancy test
    • Female patients of childbearing potential who are heterosexually active and male patients with female sexual partners of childbearing potential must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device) during the study and for 4 months following the last dose of study medication, or to abstain from sexual intercourse for this time; a woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post- menopausal, defined as the absence of menstrual periods for 12 consecutive months.
    • Recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5 Grade 0 or 1 after completion of prior AML therapy with the exception of the platelet count requirements (i.e., as long as peripheral blood platelet count is >60,000/µL).
    • Adequate renal function defined as a serum creatinine <2 × upper limit of normal (ULN) or calculated creatinine clearance > 30 mL/min based on the Cockroft-Gault equation.
    • Adequate hepatic function defined as a serum total bilirubin <2 × ULN (except for Gilbert's syndrome, which will allow bilirubin ≤3.0 mg/dL), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN.
    • Willing and able to return to the clinical site for adequate follow-up and to comply with the protocol as required.

    Exclusion Criteria:

    • For subjects randomized to GPS maintenance monotherapy:
    • Continuation of any agents administered as part of induction of CR2/CR2p
    • Receiving any concurrent anti-AML systemic therapy
    • Prior clinically significant allergic reaction to Montanide, sargramostim (GM-CSF) or filgrastim (granulocyte colony stimulating factor [G-CSF]).
    • Received any investigational agent, systemic corticosteroid therapy, or other immunosuppressive therapy within 4 weeks prior to enrolment within the study. Corticosteroids for chronic conditions (at doses ≤7.5 mg/day of prednisone or equivalent) or permitted, as are inhalational, intra-ocular, intra-articular and topical corticosteroids.
    • Complete remission with incomplete hematologic recovery (CRi).
    • Complete remission with partial haematologic recovery (CRh).
    • Imminently planned hematopoietic stem cell transplant (autologous or allogeneic, with any degree of match donor).
    • Acute promyelocytic leukemia or any morphologic and molecular variants, inclusive.
    • Serious concurrent illness that in the opinion of the Investigator would pose an undue risk to the subject being participating in the clinical study.
    • History of, or who currently have, central nervous system leukemia.
    • Received a live vaccine within 30 days prior to the first dose of study drug.
    • Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    • Undergone prior allogeneic hematopoietic stem cell transplantation
    • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
    • Additional malignancy that is progressing or has required active treatment within the past 5 years, even if currently inactive or unapparent.
    • Active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
    • Hypersensitivity to Montanide or vaccine adjuvants.
    • Previous clinically significant systemic allergic reaction to Montanide, sargramostim (GM-CSF), or filgrastim (G-CSF).
    • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
    • Active infection requiring systemic therapy.
    • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. This includes any serious, intercurrent, chronic, or acute illness, such as cardiac disease (New York Heart Association [NYHA] class III or IV), hepatic disease, or other illness considered by the investigator as an unwarranted high risk for investigational drug treatment.20.Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
    • Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 30 days after the last dose of study treatment.
    • Had an allogeneic tissue/solid organ transplant.
    • Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (excluding GM-CSF, but including G CSF or recombinant erythropoietin) within 4 weeks prior to first study treatment.

    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
  • AALL1521/Incyte 18424-269: A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib with Chemotherapy in Children with De Novo High Risk CRLF-2 Rearranged and or JAK Pathway-Mutant Acute Lymphoblastic Leukemia. - NCT02723994

    1- Part 1:To evaluate initial safety and tolerability and to define the reccommended dose of ruxolitinib in combination with multi-agent chemotherapy in children and adolescents with de novo high risk Ph chromosome like cytokine receptor like factor 2 rearranged and or JAK pathway mutant B cell leukemia. 2: Part 2- to determine efficacy in combination with multi-agent chemotherapy in children and adolescents with de novo high risk Ph chromosome like cytokine receptor like factor 2 rearranged and or JAK pathway mutant B cell leukemia 3: To assess pharmacokinetics of ruxolitinib in children in combination with chemotherapy 4: To assess rates of MRD in eligible patients

    View All Details
    • Protocol Number:
      111603

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Leukemia, other

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      METHOTREXATE VINCRISTINE THIOGUANINE CYCLOPHOSPHAMIDE MERCAPTOPURINE DOXORUBICIN DAUNORUBICIN LEUCOVORIN PEG Asparaginase (PEG) PREDNISONE DEXAMETHASONE Ruxolitinib CYTARABINE

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Eligible for study when participant is 1 year to 21 years at the time of diagnosis
    • Eligible Ages in Australia and Canada; 2 years to 21 years
    • De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:
    • Age ≥ 10 years
    • White blood cell (WBC) ≥ 50 × 10^3/μL
    • CNS3 leukemia at diagnosis
    • Systemic steroid pretreatment without presteroid WBC documentation
    • Diagnostic bone marrow or peripheral blood sample must have gene expression profiling and downstream genetic testing performed by submitting diagnostic specimens under the COG AALL08B1 or APEC14B1 biology studies, or AALL1131 or its successor study. Specimens must demonstrate a Ph-like expression profile (ie, LDA-positive) as tested by low density microarray testing at the COG ALL reference laboratory or TriCore laboratory at the University of New Mexico AND must contain 1 of the following genetic lesions: (determined at COG ALL reference laboratories, or equivalent CAP/CLIA-certified laboratories approved by the medical monitor: 1. CRLF2 rearrangement* with confirmed JAK1 or JAK2 mutation (JAK+) 2. CRLF2 rearrangement* without JAK mutation 3. Other JAK pathway alterations (eg, JAK2 fusions, EPOR fusions, SH2B3 deletions, IL7RA mutations) with or without CRLF2-R, or CRLF2-R with unknown JAK status*† as determined by a COG ALL Reference Laboratory
    • Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or its successor study, or as per the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
    • Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation

    Exclusion Criteria:

    • Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
    • Trisomy 21 (Down syndrome)
    • BCR-ABL1-rearranged (Ph+) ALL
    • Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m^2
    • Alanine aminotransferase ≥ 5 × upper limit of normal (ULN) for age
    • Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
    • History or evidence of cirrhosis
    • Platelet count < 75 × 10^3/μL
    • Absolute neutrophil count (ANC) < 750/μL
    • Positive screen for hepatitis B or C
    • Known human immunodeficiency virus infection

    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
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