8 results
  • 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

    • Phase:
      Phase II

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      MK-7684A

      • Contacts:

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

    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 Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission - NCT03267433

    Primary Objective: To compare overall survival in MCL patients in MRD-negative first complete remission (CR) who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone (without autoHCT). Secondary Objectives: 1.To compare progression-free survival in MCL patients in MRDnegative CR who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone. 2. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. 3. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. 4. To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab. 5. To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab. 6. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT. 7 To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.

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    • Protocol Number:
      011813

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      RITUXIMAB

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)
    • Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until Step 1 registration. Patients may register to Step 0 without a documented Ki-67 index.
    • Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician
    • Patient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0
    • For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); patients preregistered post-induction with evidence of clinical disease progression are not eligible for preregistration
    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
    • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen
    • Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement
    • Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence
    • NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient?s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment
    • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)
    • Patients must have met eligibility criteria for the screening step
    • Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:
    • Patients are ?MRD Indeterminate?: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR
    • ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
    • Patients must have completed induction therapy within 120 days prior to preregistration to step 0, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (?day 0?) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given
    • Patient must have received at least four (4) cycles of induction therapy
    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy
    • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen
    • Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria
    • Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements
    • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
    • Human immunodeficiency virus (HIV) positive patients are not excluded, but to enroll, must meet all of the below criteria:
    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy if indicated
    • CD4 count at screening >= 300 cells/mm^3
    • No history of acquired immune deficiency syndrome (AIDS)-defining conditions
    • Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months
    • Women must not be pregnant or breast-feeding
    • 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)
    • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the 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
  • 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
  • Analysis of Circulating Lymphoid Cells in Patients With (or Treated For) Non-Hodgkins Lymphoma.

    1. Detection of lymphoid cells in blood that are clonally related to lymphoma in patients with lymphoma 2. Clonal evolution of these cells over time

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    • Protocol Number:
      011811

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

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers University Prinicipal Investigator: Roger Strair M.D., Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • Characterizing Lymphoma Survivors Experiences, Needs, and Preferences During the Transition to Cancer Survivorship: The Survivor Health Check Program Development Trial.

    To assess information and support needs, preventive health behaviors symptoms, distress, preparedness for survivorship, and survivorship care experiences. To characterize level of interest in, preferred timing, potential delivery.

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    • Protocol Number:
      132203

    • Principal Investigator:
      Sharon Manne PhD

    • Phase:
      N/A

    • Scope:
      Local

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Sharon Manne PhD
    • Rutgers Cancer Institute of New Jersey
  • Expanded Access Protocol (EAP) for Patients Receiving Lisocabtagene Maraleucel That is Nonconforming for Commercial Release. - NCT04400591

    The primary objective is to assess the safety of nonconforming lisocabtagene maraleucel in patients. The secondary objective is to assess efficacy of nonconforming lisocabtagene maraleucel in patients. The exploratory objectives are to assess duration of response (DOR), progression- free survival(PFS), and overall survival (OS).

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    • Protocol Number:
      012004

    • Principal Investigator:
      Mansi Shah MD

    • Phase:
      N/A

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      lisocabtagene maraleucel / JCAR017

      • Contacts:

      • Rutgers University Prinicipal Investigator: Mansi Shah MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Subject and/or LAR must understand and voluntarily sign an informed consent form prior to any study-related assessments/procedures being conducted. 2. Subject has relapsed and/or refractory large B-cell lymphoma and is, per the treating physician assessment, eligible for treatment with lisocabtagene maraleucel per the approved prescribing information. 3. Subject is ≥ 18 years of age at the time of signing the informed consent form. 4. Subject had a specific batch of lisocabtagene maraleucel manufactured intended for commercial treatment; however, the final manufactured product did not meet commercial release criteria. 5. Remanufacturing (eg, repeat leukapheresis and manufacturing) is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the subject. 6. Subject is clinically stable, has recovered from any toxicities prior to receiving lymphodepleting chemotherapy, and has adequate bone marrow function to receive lymphodepleting chemotherapy. The treating physician is advised to contact Medical Monitor in the event there is any concern regarding administration of lymphodepleting chemotherapy. 7. Females of childbearing potential must: 1. Have a negative pregnancy test as verified by the treating physician within 7 days prior to the first dose of lymphodepleting chemotherapy following institutional testing methodology practices. This applies even if the subject practices true abstinence from heterosexual contact. 2. Either commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, effective contraception without interruption. Contraception methods must include 1 highly effective method from screening until at least 12 months after the nonconforming lisocabtagene maraleucel administration. 3. Agree to abstain from breastfeeding during study participation and for at least 12 months following nonconforming lisocabtagene maraleucel administration. 4. There are insufficient exposure data to provide any recommendation concerning the duration of contraception and the abstaining from breastfeeding following treatment with lisocabtagene maraleucel. Any decision regarding contraception and breastfeeding after infusion should be discussed with the treating physician. 8. Male subjects must: 1. Practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 12 months after nonconforming lisocabtagene maraleucel administration even if the subject has undergone a successful vasectomy. 2. There are insufficient exposure data to provide any recommendation concerning the duration of contraception following treatment with lisocabtagene maraleucel. Any decision regarding contraception after infusion should be discussed with the treating physician 9. Subject must agree to not donate blood, organs, tissue, sperm or semen and egg cells for usage in other individuals for at least 1 year following nonconforming lisocabtagene maraleucel administration.

    Exclusion Criteria:

      1. Subject has a hypersensitivity to the active substance or to any of the excipients. 2. Subject should not experience a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of adverse events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming lisocabtagene maraleucel. 3. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness, sociologic or geographic condition that would prevent the subject from participating in the Expanded Access Protocol complying with protocol requirements in the Investigator's judgement. 4. Subject has any condition and/or laboratory abnormality that places the subject at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement 5. Pregnant or nursing women or has intention of becoming pregnant during the study. 6. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study). 7. Subject has active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of pretreatment evaluation 8. Subject has uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of nonconforming lisocabtagene maraleucel administration. 9. Subject has presence of acute or chronic graft-versus-host disease (ie, GVHD) 10. Use of the following: 1. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 72 hours prior to nonconforming lisocabtagene maraleucel administration. Physiologic replacement, topical, and inhaled steroids are permitted. 2. Low dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ≤ 300 mg/m2)given after leukapheresis to maintain disease control must be stopped ≥ 7 days prior to lymphodepleting chemotherapy. 3. Cytotoxic chemotherapeutic agents that are not considered lymphotoxic (see below) within 1 week of LD chemotherapy. Oral chemotherapeutic agents, including lenalidomide and ibrutinib, are allowed if at least 3 half-lives have elapsed prior to lymphodepleting chemotherapy. 4. Donor lymphocyte infusions within 6 weeks of nonconforming lisocabtagene maraleucel administration.

    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
  • Machine Learning-based High-throughput and Integrative Immunological Synapse Quality Evaluation As a Composite Biomarker for Predicting CAR Therapy Efficacy in Immuno-Oncology.

    1. The primary objective is to determine if a novel fluorescent assay measuring dynamic parameters of immune synapse quality can be used to assess commercial T cell products. 2. The secondary objective is to determine if a novel fluorescent assay measuring dynamic parameters of the immune synapse can be used as a biomarker to associate with CAR-T cell efficacy and toxicity.

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    • Protocol Number:
      012108

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

    • Phase:
      N/A

    • Scope:
      Local

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Roger Strair M.D., Ph.D.
    • Rutgers Cancer Institute of New Jersey
  • Managed Access Program (MAP) to Provide Access to CTL019, for Acute Lymphoblastic Leukemia (ALL) or Large B-cell Lymphoma Patients without of Specification Leukapheresis Product and/or Manufactured Tisagenlecleucel Out of Specification for Commercial Release. - NCT03601442

    The purpose of this Managed Access Program (MAP), which is an intermediate size patient population Expanded Access, is to allow treatment with tisagenlecleucel (CTL019) for eligible patients diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas who meet all of the following criteria: are 1) consistent with the approved prescribing information, 2) unable to receive commercially manufactured product due to failure of the incoming apheresis material to meet acceptance specifications or final outgoing product to meet the commercial release specifications or other specification within the prescribing information, and 3) where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product. The requesting treating physician submitted a request to Novartis to access tisagenlecleucel that does not meet commercial specifications, which was reviewed and approved by the medical team experienced with tisagenlecleucel and the indication. Please refer to the latest Investigator s Brochure (IB) or approved prescribing information for overview of tisagenlecleucel including: non-clinical and clinical experience, risk and benefits. Novartis will continue to provide any new safety information to the Treating Physician as they emerge.

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    • Protocol Number:
      021908

    • Phase:
      N/A

    • Scope:
      National

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

    • Therapies Involved:
      Chemotherapy multiple agents systemic Immunotherapy

    • Drugs Involved:
      CTL019 FLUDARABINE CYCLOPHOSPHAMIDE ETOPOSIDE CYTARABINE

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria: 1. Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP).
    • Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label. 2. Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label). These may include:
    • pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
    • adult patients with r/r diffuse large B-cell lymphoma (DLBCL) 3. Informed consent must be obtained prior to treatment 4. The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications

    Exclusion Criteria:

      Patients eligible for this Treatment Plan must not meet any of the following criteria: 1. Contraindications as per the approved local label or the IB.

    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