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  • A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination with Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients with Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1) - NCT05685173

    The primary objective of the study is: - To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine RP2D regimen(s) (defined as either a MTD regimen or a lower dose regimen) of REGN5837 in combination with odronextamab in patients with relapsed or refractory aggressive B-NHL. The secondary objectives of the study are: - To evaluate the pharmacokinetics (PK) of REGN5837 when given in combination with odronextamab - To evaluate the PK of odronextamab when given in combination with REGN5837 - To assess the immunogenicity of REGN5837 and odronextamab - To assess the preliminary anti-tumor activity of REGN5837 in combination with odronextamab in patients with relapsed or refractory aggressive B-NHL The exploratory objectives of the study are: - To evaluate the association between clinical efficacy and safety with biomarkers of systemic immune activation (serum cytokine levels, T-cell counts and activation markers) - To evaluate the association between disease response and/or relapse and the change from baseline in the count and phenotype of tumor-infiltrating T cells and tumor B cell target antigen (CD20, CD22) expression - To evaluate association of the molecular Minimal Residual Disease (MRD) status in patients with a clinical CR with progression-free survival (PFS) and OS - To assess other biomarkers (pharmacodynamic, predictive, and prognostic) potentially related to REGN5837 in combination with odronextamab exposure, anti-tumor activity, and safety - To evaluate the relationships among pharmacodynamics, drug concentrations, and clinical safety and efficacy measure

    View All Details
    • Protocol Number:
      012303

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      REGN5837 Odronextamab(REGN1979)

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria:

      1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent. 2. Measurable disease on cross sectional imaging as defined in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 4. Adequate bone marrow, renal and hepatic function as defined in the protocol 5. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.

    Key Exclusion Criteria:

      1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab 2. Diagnosis of mantle cell lymphoma (MCL) 3. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS lymphoma 4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter 5. Standard radiotherapy within 14 days of first administration of study drug. 6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab 7. Co-morbid conditions, as described in the protocol 8. Infections, as described in the protocol 9. Allergy/hypersensitivity: Known hypersensitivity to both allopurinol and rasburicaseNOTE: Other protocol defined 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
  • A Phase 1b Multicenter, Open-label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non- Hodgkin Lymphoma - NCT05784441

    The primary objectives are to assess the safety and tolerability of JNJ-90009530 and to determine the recommended Phase 2 dose(s)(RP2D[s]). Secondary objectives are to evaluate the preliminary efficacy of JNJ-90009530 in participants with r/r B-NHL and to characterize JNJ-90009530 pharmacokinetics (PK) in blood.

    View All Details
    • Protocol Number:
      012317

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      JNJ-90009530

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Key Inclusion Criteria

    • Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
    • All participants must have relapsed or refractory disease for each histologic subtype
    • Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
    • Follicular lymphoma Grade 1-3a and Marginal Zone Lymphoma: Participants must have >=2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
    • Tumor must be cluster of differentiation (CD) 20 positive
    • Measurable disease as defined by Lugano 2014 classification
    • Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

    Key Exclusion Criteria

    • Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
    • Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
    • Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
    • Uncontrolled active infections
    • History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
    • History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association [NYHA] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
    • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder
    • Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
    • Active central nervous system (CNS) involvement by malignancy
    • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

    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
  • A Phase 1b Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma. - NCT05421663

    The primary objectives are to assess the safety and tolerability of JNJ-90014496 and to determine the recommended Phase 2 dose(s) (RP2D[s]). The secondary objectives are to evaluate the preliminary efficacy of JNJ-90014496 in participants with r/r B-NHL and to characterize JNJ-90014496 PK in blood.

    View All Details
    • Protocol Number:
      012316

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      JNJ-90014496

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Joanna Rhodes MD

    Read Inclusion & Exclusion Criteria

    • Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
    • Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular lymphoma
    • Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
    • Must have relapsed or refractory disease with the following indications for each histologic subtype: Mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy, or >= 1 line of systemic therapy for participants who are ineligible for autologous stem cell transplant; Follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have >= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
    • Measurable disease as defined by Lugano 2014 classification
    • Eastern cooperative oncology group (ECOG) performance status of either 0 or 1

    Exclusion Criteria

    • Diagnosis of Human herpes virus (HHV) 8-positive diffuse large B Cell lymphoma (DLBCL)
    • Prior allogeneic hematopoietic stem cell transplantation (HSCT)
    • Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
    • Uncontrolled active infections
    • History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
    • History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
    • History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder
    • Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
    • Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

    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
  • A phase 2 study of mosunetuzumab with lenalidomide augmentation as first-line therapy for follicular and marginal zone lymphoma - NCT04792502

    Primary: To determine the Overall Response Rate (ORR), and Complete Response rate (CR) to first-line therapy with 8-12 cycles of mosunetuzumab ? lenalidomide augmentation among patients with follicular lymphoma (FL) and marginal zone lymphoma (MZL), measured at the time of the PRA. To determine the rates of toxicities, including cytokine release syndrome (CRS), neurotoxicity, and tumor flare reaction, among patients with previously untreated FL/MZL receiving first-line mosunetuzumab ? lenalidomide augmentation. Secondary: To determine the rates of minimal residual disease (MRD), progression-free survival (PFS), overall survival (OS), and duration of response/complete response (DOR) at 2 years following first-line therapy with mosunetuzumab ? lenalidomide augmentation among patients with FL/MZL. To determine the rate of CR among patients with FL/MZL receiving first-line mosunetuzumab alone (4 cycles), and the rate of subsequent conversion to CR with lenalidomide augmentation among patients who do not achieve CR with mosunetuzumab alone. To preliminarily assess rates of ORR, CR, PFS, and OS at 2 years following first-line therapy with mosunetuzumab (? lenalidomide augmentation) among patients with specific histologies: FL and MZL (including MZL subtypes). To evaluate the potential for tumor flare reaction and CRS among patients who receive lenalidomide augmentation after first-line treatment with mosunetuzumab alone. To evaluate the frequency and safety of tocilizumab use during first-line treatment of FL/MZL with mosunetuzumab and during augmentation with mosunetuzumab plus lenalidomide.

    View All Details
    • Protocol Number:
      012319

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

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

    • Drugs Involved:
      Mosunetuzumab LENALIDOMIDE

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures. 2. Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients <18 years of age, they are excluded from this study. 3. Histologically confirmed diagnosis of:
    • follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or
    • marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL/MZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis. 4. Agreement to provide, if available, lymphoma tissue for correlative analyses. 5. At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as >1.0 cm in its longest diameter; with the exception of splenic MZL, which must be evaluable using the International SMZL Group criteria. 6. No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed. 7. Indication to start systemic therapy for lymphoma:
    • Patients with FL must meet one of the GELF criteria:
    • any mass ≥7 cm (except spleen);
    • at least 3 nodes >3 cm in diameter;
    • symptomatic spleen enlargement;
    • local symptoms or compromise of normal organ function due to tumor mass;
    • presence of ascites or pleural effusion;
    • presence of B symptoms (fever, night sweats, or unintentional weight loss of >10% over ≤6 months);
    • serum lactate dehydrogenase or beta-2-microglobulin above upper limit of normal;
    • cytopenias due to underlying lymphoma (i.e., absolute neutrophil count <1.0 × 109/L, hemoglobin <10 g/dL, and/or platelet count <100 × 109/L).
    • Patients with MZL must have an indication to start therapy as assessed by the investigator. 8. Performance status ECOG 0, 1, or 2. 9. Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly):
    • hemoglobin ≥9 g/dL,
    • absolute neutrophil count ≥1.0 x 109/L,
    • platelet count ≥75 x 109/L. 10. Glomerular filtration rate (GFR) ≥40 mL/min/1.73m2 using the Mayo Quadratic Formula. 11. The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because lenalidomide used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 12. Agreement to enroll in and comply with all local requirements of the REVLIMID® (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS®) program for the purpose of lenalidomide acquisition.

    Exclusion Criteria:

      1. Grade 3b follicular lymphoma or transformed lymphoma. 2. Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma. 3. Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation. 4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products. 5. Known NYHA class 3/4 congestive heart failure, LVEF <40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia. 6. Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen. 7. History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the exception of: hypothyroidism (on stable dose of thyroid replacement therapy), asthma managed with inhaled medications only; type 1 diabetes mellitus on stable insulin regimen, Sjögren syndrome, immune thrombocytopenia or autoimmune hemolytic anemia that does not require systemic therapy; dermatologic condition (including eczema, psoriasis, lichen simplex chronicus, or vitiligo) with skin manifestations with rash covering <10% of body surface area and not requiring treatment other than low-potency topical corticosteroids for >12 months prior to registration. 8. Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment using <10 mg/day prednisone or equivalent within 2 weeks prior to first treatment; a brief course of palliative corticosteroids at higher doses (prednisone up to 100 mg daily, for up to 7 days) is allowed, but must be completed at least 7 days before the first dose of mosunetuzumab. 9. Any of the following conditions:
    • active bacterial infection requiring antibiotics
    • known or suspected chronic active Epstein Barr virus (CAEBV) infection
    • history of hemophagocytic lymphohistiocytosis (HLH)
    • confirmed progressive multifocal leukoencephalopathy (PML)
    • known active EBV or CMV viremia
    • positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total/IgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to take entecavir or tenofovir, and undergo periodic DNA testing
    • positive hepatitis C virus (HCV) antibody, unless a negative polymerase chain reaction (PCR) for HCV is documented
    • positive test for HIV. 10. Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab dose or anticipation that such a live, attenuated vaccine will be required during the study. 11. Current or past history of CNS disease, including stroke, epilepsy, or CNS vasculitis, or an advanced neurodegenerative disease; with the exception of: stroke >2 years before registration without any residual neurologic deficits and no subsequent transient ischemic attacks; history of epilepsy with no seizures for >2 years and not using any antiepileptic therapy; well-controlled Parkinson's disease (with no need for a significant medication adjustment for > 6 months). 12. History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or another malignancy treated curatively with a documented remission >2 years before registration are eligible. 13. 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 requiring treatment with IV antibiotics or hospitalization within 4 weeks before the first dose of mosunetuzumab. 14. Clinically significant liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis. 15. Any major surgery within 4 weeks before the first dose of mosunetuzumab, other than lymph node biopsy for diagnosis. 16. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol. 17. Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab:
    • AST or ALT >3x ULN
    • total bilirubin >2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only)
    • INR>1.5 x ULN without anticoagulation
    • PTT or APTT >1.5x ULN in the absence of lupus anticoagulant. 18. Any radiation therapy within 2 weeks prior to first dose of mosunetuzumab. 19. Pregnancy, breast-feeding, or prisoner status. Women of childbearing potential must have a negative pregnancy test within 2 weeks before first dose of mosunetuzumab, and must undergo repeat pregnancy testing during each cycle of lenalidomide therapy (see Inclusion Criterion 11).

    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.

    • Monmouth Medical Center
    • Community Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
    • Trinitas Regional Medical Center – Williamson Street Campus
  • A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an anti CD20 ? anti-CD3 Bispecific Antibody, in Combination with CHOP (O-CHOP) versus Rituximab in Combination with CHOP (R-CHOP) in Previously Untreated Participants with Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3). - NCT06091865

    Part 1 (safety run-in): Primary objective: To assess the safety, tolerability and dose limiting toxicities (DLTs) of odronextamab in combination with CHOP (O-CHOP) in participants previously untreated for Diffuse Large B-Cell Lymphoma (DLBCL) with high-risk features and determine the dose of odronextamab to combine with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in Part 2. Secondary objectives: a. To evaluate the preliminary anti-tumor activity of O-CHOP in participants with previously untreated DLBCL with high-risk features b. To evaluate the pharmacokinetics (PK) of odronextamab when administered in combination with CHOP c. To assess the immunogenicity of odronextamab when administered in combination with CHOP Part 2 (randomized portion): Primary objective: To compare the efficacy of O-CHOP with that of R-CHOP in participants with previously untreated DLBCL with an (International Prognostic Index) IPI score ≥3, and subsequently in all participants with an IPI score ≥2 Key secondary objective: To compare therapeutic benefit with O-CHOP versus that with R-CHOP assessed by event-free survival (EFS), complete response (CR) and overall survival (OS) Secondary objectives: a. To compare supplemental measures of efficacy for O-CHOP versus R-CHOP b. To compare safety and tolerability of O-CHOP with that of R-CHOP c. To evaluate the PK of odronextamab when administered in combination with CHOP d. To assess the immunogenicity of odronextamab when administered in combination with CHOP e. To compare measurable residual disease (MRD) with O-CHOP versus R-CHOP f. To compare the treatment effects on patient reported physical function between O-CHOP and R-CHOP g. To compare the treatment effects of O-CHOP versus R-CHOP on patient reported outcomes (PROs) including health-related quality of life, functioning and disease-related symptoms, as measured by EORTC QLQ-C30, FACT-LymS, EQ-5D-5L, two global anchors Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC), collected during study visits h. To evaluate the overall impact of treatment toxicity based upon the single item GP5 of the validated FACT-G questionnaire ( I am bothered by side effects of treatment )

    View All Details
    • Protocol Number:
      012307

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      RITUXIMAB Odronextamab(REGN1979)

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    KEY Inclusion Criteria:

      1. Previously untreated participants for lymphoma with documented cluster of differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL (Part 1A only) 2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 4. Life expectancy ≥ 12 months 5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only; 6. Adequate hematologic and organ function, as defined in the protocol.

    KEY Exclusion Criteria:

      1. Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology 2. Another active malignancy, significant active disease or medical condition, as described in the protocol 3. Peripheral neuropathy Grade ≥3 4. Treatment with any systemic anti-lymphoma therapy, except for participants with relapsed/refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent follicular lymphoma after treatment with systemic anti-lymphoma therapy. 5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment 6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol 7. Allergy/hypersensitivity to study drugs, as described in the protocol 8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.Note: Other protocol-defined 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.

    • Cooperman Barnabas Medical Center
    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Jersey City Medical Center
    • Rutgers Cancer Institute
  • A Phase 3, Randomized, Open-Label Study Comparing the Efficacy and Safety of the Combination of Beleodaq-CHOP or Folotyn-COP to the CHOP Regimen Alone in Newly Diagnosed Patients with Peripheral T-Cell Lymphoma - NCT06072131

    Part 1 (Dose Finding): Primary Objective To identify one of two dose-levels, each for belinostat and pralatrexate, that is optimal in polychemotherapy for the part 2 study based on safety and ORR at 3 months. Part 2 (Efficacy and Safety): Primary Objective To compare the progression-free survival (PFS) of patients with newly diagnosed peripheral T-cell lymphoma (PTCL) treated for up to 6 cycles with belinostat in combination with CHOP (Bel-CHOP) or pralatrexate in combination with COP (Fol-COP) to CHOP alone Secondary Objectives To compare the overall survival (OS) for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol-COP to CHOP alone To compare the objective response rate for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol-COP to CHOP alone Treatment compliance Exploratory Objectives Dose intensity To compare the duration of response for patients with newly diagnosed PTCL treated with Bel- CHOP or Fol-COP to CHOP alone To compare the proportion of patients with newly diagnosed PTCL receiving hematopoietic stem cell transplantation who are treated with Bel-CHOP or Fol-COP to treatment with CHOP alone Safety Objectives To evaluate the safety profiles for patients with newly diagnosed PTCL treated with Bel-CHOP or Fol- COP compared to CHOP alone

    View All Details
    • Protocol Number:
      012320

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      Pralatrexate (Folotyn) Belinostat

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Yun Kyoung Tiger

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Patient with newly diagnosed, untreated histology-proven PTCL based on local pathology review who is eligible for receiving, Belinostat, Pralatrexate, and CHOP. Pathology material must be available at the site for each patient before enrollment so it can be sent to the Sponsor (or designee) for confirmation. The following subtypes, as defined by the updated World Health Organization (WHO) classification, may be included. This information should be available for eligibility: 1. Pathology subtype:
    • Peripheral T-cell lymphoma, not otherwise specified
    • Angioimmunoblastic T-cell lymphoma
    • Anaplastic lymphoma kinase (ALK)- negative anaplastic large-cell lymphoma (ALCL)
    • Follicular T cell lymphoma
    • Others: Extra-nodal natural killer/T-cell lymphoma, nasal type; enteropathy-associated T-cell lymphoma; hepatosplenic T-cell lymphoma; and subcutaneous panniculitis-like T-cell lymphoma 2. CD30 expression 3. TFH phenotype 2. Patient has at least 1 site of measurable disease according to Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria as assessed by the local Investigator (Appendix 3) 3. Patient has an Eastern Cooperative Oncology Group performance status ≤2 4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by: a. Absolute neutrophil count ≥1.5×109
    • L b. Platelet count ≥100×109
    • L c. Total bilirubin ≤1.5 mg/dL d. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤3×the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) e. Serum creatinine ≤2.0×ULN or calculated creatinine clearance of ≥60 mL/min 5. Part 2 (Efficacy and Safety) - disease related hypoplasia, hepatological or renal dysfunction can be included if any of the treatment groups can be administered based on package insert recommendation with the following restrictions: 1. Absolute neutrophil count ≥1.0×109/L or >= ≥1.5×109/L if bone marrow involvement 2. Platelet count ≥100×109
    • L or ≥75×109
    • L if bone marrow involvement 3. Total bilirubin ≤1.5 mg/dL 4. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤3×the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) 5. Serum creatinine ≤2.0×ULN 6. Calculated creatinine clearance of ≥60 mL/min 6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal). 7. A decision whether to use prophylactic growth factor for cycle 1 or not has been made 8. Patient must be willing and capable of giving written informed consent and must be able to adhere to dosing and visit schedules and meet all study requirements 9. Patient (male/female) is at least 18 years of age at the time of informed consent 10. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of study treatment 11. Females of childbearing potential must have a negative urine pregnancy test within 4 weeks prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test

    Exclusion Criteria:

      1. Patients with a diagnosis of: 1. Precursor T-cell lymphoma or leukemia 2. Adult T-cell lymphoma/leukemia 3. T-cell prolymphocytic leukemia 4. T-cell large granular lymphocytic leukemia 5. Primary cutaneous type ALCL 6. Cutaneous T-cell lymphoma (mycosis fungoides/Sezary syndrome) 7. ALCL except if Brentuximab Vendotin cannot be utilized 2. Patients taking drugs which are potent UGT1A1 inhibitors must discontinue one week before randomization; drug can be resumed if the treatment doesn't include belinostat 3. Patient with an active concurrent malignancy/life-threatening disease with the exception of non melanoma skin tumors and in situ cervical cancer if they have received treatment resulting in complete resolution of the cancer and currently have no clinical, radiologic, or laboratory evidence of active or recurrent disease. If there is a history of prior malignancies/life-threatening diseases, the patient must be disease free for at least 5 years 4. Prior histone deacetylase (HDAC) inhibitor or pralatrexate therapy 5. Any known cardiac abnormalities such as baseline prolongation of QT/corrected QT (QTc) interval (ie,demonstration of a QTc interval >450 msec); long QT syndrome; myocardial infarction within 6 months prior to starting study; history of significant cardiovascular disease; the required use of a concomitant medication that may cause Torsades de Pointes 6. Patient with uncontrolled hypertension 7. Patients with a known HIV-positive diagnosis, hepatitis B virus or hepatitis C virus diagnosis with detectable viral load or immunological evidence of chronic active disease 8. Patient with central nervous system metastasis 9. Patient with an active uncontrolled infection, underlying medical condition, laboratory abnormality, or other serious illness that would impair the ability of the patient to receive protocol treatment 10. Patient who has used any investigational drugs, biologics, or devices within 28 days prior to study treatment or plans to use any of these during the course of the study 11. Patient with a known history of drug or alcohol abuse 12. Pregnant or breastfeeding women

    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
  • 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.

    View All Details
    • Protocol Number:
      012107

    • 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 Cancer Institute of New Jersey Prinicipal Investigator: Matthew Matasar

    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) within two weeks prior to Gpt, 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
  • A Phase II/III Randomized Study of R-miniCHOP With or Without Oral Azacitidine (CC-486) in Participants Age 75 years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma, Grade IIIb Follicular Lymphoma, Transformed Lymphoma, and High-Grade B-cell Lymphomas With MYC and BCL2 and/or BCL6 Rearrangements. - NCT04799275

    Primary Objectives: - Safety run-in: To determine if the addition of CC-486 to R-miniCHOP results in excess toxicity compared to R-miniCHOP alone that would preclude the combination from being studied further. Phase II Component: To determine if the CC-486 + R-miniCHOP regimen should be tested further (Phase III) against the control R-miniCHOP alone based on progression-free survival (PFS). Phase III component: To compare the overall survival (OS) between CC-486 + R miniCHOP and R-miniCHOP alone. Secondary Objectives: - To assess the feasibility of delivering at least 4 cycles of CC-486 with R-miniCHOP in this population. - To assess toxicity for CC-486 + R-miniCHOP and for R-miniCHOP. - To compare complete response rates, as defined by Lugan

    View All Details
    • Protocol Number:
      012103

    • Phase:
      Phase II/III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      CYCLOPHOSPHAMIDE DOXORUBICIN RITUXIMAB VINCRISTINE CC-486

      • Contacts:

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

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants must have histologically or cytologically confirmed diffuse large B-cell lymphoma (DLBCL), Ann Arbor Stage IIX (bulky), III or IV. Participants with DLBCL transformed from follicular lymphoma (FL) or marginal zone lymphoma (MZL, including mucosa-associated lymphoid tissue [MALT] lymphomas), lymphoplasmacytic lymphoma (LPL), or nodular lymphocyte-predominant Hodgkin Lymphoma (NLPHL) are eligible. Participants with Grade IIIB follicular lymphoma (FL) or high-grade B-cell lymphomas with MYC and BCL2 and/or BCL6 rearrangements are also eligible. Participants with DLBCL that arose from prior CLL (Richter's transformation) are not eligible.
    • As defined by the World Health Organization (WHO), eligible lymphoma subtypes include the following:
    • DLBCL, not otherwise specified (NOS)
    • DLBCL, germinal-center B-cell type (GCB)
    • DLBCL, activated B-cell type (ABC)
    • T-cell histiocyte-rich B-cell lymphomas (THRBCL)
    • Primary cutaneous DLBCL, leg type
    • Intravascular large B cell lymphoma
    • EBV+ DLBCL, NOS
    • DLBCL associated with chronic inflammation
    • HHV8+ DLBCL, NOS
    • High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
    • High grade B-cell lymphoma, NOS
    • Follicular lymphoma grade 3b
    • Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter >= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 42 days prior to registration.
    • Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to registration). Participants with known HIV must have a CD4 count checked within 28 days prior to registration, but may proceed with therapy regardless of CD4 count.
    • All participants must be screened for chronic hepatitis B virus (HBV) within 28 days prior to registration. Participants with known HBV infection (positive serology) must also have a HBV viral load performed within 28 days prior to registration, and participants must have an undetectable HBV viral load on suppressive therapy within 28 days prior to registration. Participants found to be HBV carriers during screening are eligible and must receive standard of care prophylaxis. Participants with active hepatitis B (HBV viral load > 500 IU/mL) within 28 days prior to registration are not eligible
    • Participants with a known history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load within in 28 days prior to registration
    • Participants must have a Zubrod performance status of 0-2
    • Participants must have adequate renal function, as demonstrated by a creatinine clearance, calculated by the Cockcroft and Gault formula, of >= 30 ml/min that was obtained within 28 days prior to registration
    • Aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =< 2.5 x IULN (within 28 days prior to registration)
    • Total bilirubin =< 2 x institutional upper limit of normal (IULN), unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver (within 28 days prior to registration). Note: If total bilirubin is elevated, and direct bilirubin is subsequently performed (within 28 days prior to registration) and resulted to be =< 2 x IULN, the participant will be considered eligible
    • Absolute neutrophil count (ANC) >= 1000/mcL (within 28 days prior to registration)
    • Platelets >= 75,000/mcL (within 28 days prior to registration)
    • Hemoglobin (Hgb) >= 8 g/ dL (within 28 days prior to registration)
    • If there is a documented lymphomatous involvement of the bone marrow, bone marrow function within 28 days prior to registration, as evidenced by:
    • ANC >= 500/mcL
    • Platelets >= 50,000/mcL
    • Hemoglobin (Hgb) >= 8 g/ dL
    • Participants must have a left ventricular ejection (LVEF) fraction >= 45% as measured by echocardiogram or radionuclide (multigated acquisition scan [MUGA]) ventriculography within 56 days prior to registration
    • For the duration of the study treatment period and for at least 4 months following the last dose of study drug, male participants must agree to use effective contraceptive methods during sexual contact with a female of childbearing potential (FCBP) and must agree to refrain from semen or sperm donation during the same timeframe. Effective contraceptive methods include a history of vasectomy, use of hormonal contraception or an intrauterine device (IUD) by the female partner, or use of condoms
    • A FCBP is a sexually mature woman who: 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)

    Exclusion Criteria:

    • Participants must not have known lymphomatous involvement of the central nervous system (CNS)
    • Participants must not have active inflammatory bowel disease (such as, Crohn's disease, ulcerative colitis), celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity
    • Participants must not have received any prior cytotoxic chemotherapy or rituximab for treatment of the newly diagnosed DLBCL except for the pre-phase treatment (within specified dose range) that may have either started before or may start after registration to S1918. Inhaled, nasal, and topical steroid use is allowed. Prior cytotoxic chemotherapy and/or antibody therapy for an indolent lymphoma prior to transformation is allowed. Up to 4 doses of intrathecal (IT) chemotherapy administered for central nervous system (CNS) prophylaxis is allowed in addition to protocol therapy. High-dose intravenous methotrexate is not allowed.
    • Participants must not have received more than a cumulative of dose 250 mg/m^2 of prior doxorubicin (or equivalent dose of another anthracycline, such as epirubicin) therapy (at any time prior to registration).
    • Participants must not currently be receiving any other investigational agents
    • Participant must not have a history of allergic reactions attributed to azacitidine, mannitol, or other hypomethylating agents
    • Participants must not have active infection (systemic fungal, bacterial, or viral infection) that is not controlled (defined as ongoing signs/symptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment)
    • Participants must not have active cardiac disease within 26 weeks prior to registration, including: symptomatic congestive heart failure (New York Heart Association [NYHA] class 4), unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or myocardial infarction
    • Participants must not have >= grade 2 neuropathy, by Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0, within 28 days prior to registration
    • Participants must not have any other known uncontrolled intercurrent illness including, but not limited to ongoing psychiatric illness/social situations that would limit compliance with study requirements

    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.

    • Monmouth Medical Center
    • Monmouth Medical Center Southern Campus
    • Community Medical Center
    • Newark Beth Israel Medical Center
    • Rutgers Cancer Institute
  • 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 MRD negative 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.

    View All Details
    • Protocol Number:
      011813

    • Phase:
      Phase III

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Immunotherapy

    • Drugs Involved:
      RITUXIMAB

      • Contacts:

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

    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
  • Antibodies to Commensal Bacteria in Lymphoma Pathogenesis

    To determine if there is evidence of immune reactivity against commensal bacterial antigens in patients with B-cell non-Hodgkin lymphoma.

    View All Details
    • Protocol Number:
      012209

    • Phase:
      N/A

    • Scope:
      Local

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Yun Kyoung Tiger
    • Rutgers Cancer Institute
  • 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.

    View All Details
    • 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
  • First-in-Human Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of the BTK Degrader, ABBV-101, in Participants with B-cell Malignancies - NCT05753501

    Primary: To characterize the safety and confirm tolerability of ABBV-101 Secondary: To evaluate the pharmacokinetics (PK) following oral dose administration of ABBV-101 To evaluate the preliminary efficacy of ABBV-101 in specified subsets of participants with R/R B-cell NHL as defined by the disease-specific response criteria

    View All Details
    • Protocol Number:
      012321

    • Phase:
      Phase I

    • Scope:
      National

    • Applicable Disease Sites:
      Non-Hodgkin's Lymphoma

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      ABBV-101

      • Contacts:

      • Rutgers Cancer Institute of New Jersey Prinicipal Investigator: Joanna Rhodes MD

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • For Dose Escalation (Part 1) only: Participants with documented diagnosis for one of the following 3L+ B-cell malignancies, from one of the following WHO-defined histologies (Swerdlow et al 2016):
    • Chronic lymphocytic leukemia (CLL)
    • Small lymphocytic lymphoma (SLL)
    • Chimeric antigen receptor T-cells (CAR-T)/hematopoietic cell transplant (HCT) relapsed/refractory (R/R) or ineligible diffuse large b-cell lymphoma (DLBCL) from the following histologies: DLBCL not otherwise specified (NOS) (germinal center B cell [GCB] and non-GCB DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, anaplastic lymphoma kinase positive (ALK+) large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS.
    • Mantle cell lymphoma (MCL)
    • Follicular lymphoma [FL] (grades 1-3b)
    • Marginal zone lymphoma [MZL] (splenic, extranodal, and nodal)
    • Waldenström macroglobulinemia (WM)
    • Transformed indolent non-Hodgkin's lymphoma (iNHL)
    • For Dose Expansion (Part 2) only: Participants with documented diagnosis of CLL who are 3L+ including those with Bruton's tyrosine kinase (BTK) mutations or CAR-T/HCT R/R or ineligible non-GCB DLBCL who are 3L+ with histology based on criteria established by the World Health Organization (WHO).
    • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
    • Participant has a life expectancy >= 12 weeks.
    • Prior Bruton's tyrosine kinase inhibitor (BTKi) is allowed.
    • Adequate hematologic, renal, and hepatic function per the protocol.
    • Participants with prior central nervous system (CNS) disease that have been effectively treated may be eligible.

    Exclusion Criteria:

    • Previously treated with a Bruton's tyrosine kinase (BTK) degrader.
    • Known active CNS disease, or primary CNS lymphoma.
    • Uncontrolled active systemic infection, or active cytomegalovirus infection, known history of human immunodeficiency virus (HIV), active hepatitis B or C 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
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