8 results
  • 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 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)

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    • 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, 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
  • COG AHOD1822:An Open-Label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline Chemotherapy (KEYNOTE 667). - NCT03407144

    1. To evaluate the objective response rate (ORR) by International Working Group (IWG) criteria as assessed by blinded independent central review (BICR)of pembrolizumab in combination with chemotherapy in slow early responders (SERs) by risk group (low, high). 2. To evaluate the rate of Positron Emission Tomography (PET) negativity, 2-year event-free survival (EFS) after study enrollment by IWG criteria as assessed by BICR, and overall survival (OS) of pembrolizumab in combination with chemotherapy in SERs by risk group 3. To evaluate the exposure to radiation therapy (RT) and its associated toxicity in SERs by risk group 4. To evaluate the 3-year EFS and OS in rapid early responders (RERs) by risk group 5. To evaluate serum TARC as a potential biomarker in SERs by risk group 6. To evaluate the safety of pembrolizumab in combination with chemotherapy in SERs by risk group

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    • Protocol Number:
      111902

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Group 1: Must have newly diagnosed, pathologically confirmed classical Hodgkin Lymphoma (cHL) at Stages IA, IB and IIA without bulky disease. Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB
    • Has measurable disease per investigator assessment
    • Male participants are eligible to participate if they agree to the following during the intervention period: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic
    • Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
    • A WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention
    • Performance status: Lansky Play-Performance Scale ≥50 for children up to and including 16 years of age OR Karnofsky score ≥50 for participants >16 years of age
    • Has adequate organ function

    Exclusion Criteria:

    • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
    • WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment
    • Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%
    • Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study
    • Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from AEs due to previously administered agents
    • Is expected to receive a live vaccine within 30 days prior to the first dose of pembrolizumab
    • Is 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
    • Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL)
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
    • Has a known additional malignancy that is progressing or requires active treatment
    • Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis
    • Has severe hypersensitivity (≥Grade 3) to any study therapies including any excipients
    • Has an active autoimmune disease that has required systemic treatment in past 2 years
    • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
    • Has an active infection requiring systemic therapy
    • Has a known history of human immunodeficiency virus (HIV) infection
    • Has a known history of Hepatitis B or known active Hepatitis C virus infection
    • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant'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
    • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of 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
  • 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:
      Dennis Cooper M.D

    • 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: Dennis Cooper M.D

    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
  • Exploring Patient and Caregiver Perspectives and Experiences with Financial Toxicity

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

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    • Protocol Number:
      132105

    • Principal Investigator:
      Biren Saraiya M.D

    • Phase:
      N/A

    • Scope:
      Local

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

      • Contacts:

      • Rutgers University Prinicipal Investigator: Biren Saraiya M.D
    • Rutgers Cancer Institute of New Jersey
  • 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
  • SWOG-S1826: A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma. - NCT03907488

    To compare the progression-free survival (PFS)in patients with newly diagnosed advanced stage classical Hodgkin lymphoma randomized toN-AVD (nivolumab, doxorubicin, vinblastine, dacarbazine) versus that obtained with BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine).

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    • Protocol Number:
      111907

    • Principal Investigator:
      Richard Drachtman M.D.

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Hodgkin's Lymphoma

    • Therapies Involved:
      Radiotherapy Chemotherapy (NOS)

    • Drugs Involved:
      Opdivo (Nivolumab) Brentuximab vedotin

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • All patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible.
    • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter >= 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave.
    • Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, MRI or MR-PET is acceptable in event that PET-CT is contra-indicated, however if it is later possible to administer a PET-CT, then PET-CT is strongly preferred for the interim scan (after cycle 2) (if performed) and the EOT assessment. Otherwise, if PET-CT is not subsequently possible, then the same modality as baseline must be used throughout the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.
    • Patients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted.
    • Patients must not have had prior solid organ transplant.
    • Patients must not have had prior allogeneic stem cell transplantation.
    • Patients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g. measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).
    • At registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator's intent-to-treat with residual PET RT.
    • All pediatric patients (< 18 years of age) will be considered intent-to-treat with Residual PET RT at time of registration.
    • Patients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients =< 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only.
    • Adults (age 18 or older): Creatinine clearance >= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight. Pediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:
    • Measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2, or
    • Serum creatinine =< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:
    • Age < 13 maximum serum creatinine: Male 1.2 mg/dL; Female 1.2 mg/dL
    • Age 13 to < 16 maximum serum creatinine: Male 1.5 mg/dL; Female 1.4 mg/dL
    • Age 16-17 maximum serum creatinine: Male 1.7 mg/dL; Female 1.4 mg/dL
    • Total bilirubin =< 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).
    • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).
    • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Patients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction >= 50% or a shortening fraction of >= 27%. For all patients, the ECHO, MUGA, or functional cardiac imaging scan must be performed within 42 days prior to registration.
    • Patients with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable or unquantifiable viral load at their most recent viral load test within 6 months prior to registration.
    • Patients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load within 6 months prior to registration and no residual hepatic impairment are eligible.
    • Patients must not have any known central nervous system lymphoma.
    • Patients must not have a history of or active interstitial pneumonitis or interstitial lung disease.
    • Patients must not have had a diagnosis of inherited or acquired immunodeficiency.
    • Patients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1.
    • Patients with peripheral neuropathy must have < grade 2 at date of registration.
    • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), as well as symptomatic disease (e.g.: rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.
    • No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years.
    • Females of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
    • Patients must have one formalin-fixed paraffin embedded (FFPE) diagnostic tumor block or at least 1 diagnostic, 4-5 micron, hematoxylin and eosin (H&E) slide collected prior to registration and available for submission.
    • Patients must be offered participation in banking for planned translational medicine and future research. With patient consent, any residuals from the mandatory tissue submission will also be banked for future research.
    • Patients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must complete the PROMIS Fatigue, the FACT/GOG-Ntx, and the PROMIS Global prior to registration.
    • Patients who can complete Patient-Reported Outcome instruments in English, Spanish, or French must also agree to complete the PROMIS Fatigue, the FACT/GOG-Ntx, the PROMIS Global, and the PRO-CTCAE (or Ped PRO-CTCAE) at the scheduled on-study assessment timepoints.
    • Patients must be informed of the investigational nature of this study and all patients and/or their parents or legal guardians (for patients < 18 years of age) must sign and give informed consent and assent (where appropriate) in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board Initiative (CIRB) regulations.
    • Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

    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
    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute of New Jersey