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A Phase 1 First in Human Study of ARV-393 in Adult Participants with Advanced Non-Hodgkins Lymphoma.
- NCT06393738
Primary Objective:
To evaluate the safety and tolerability of ARV-393, determine MTD if necessary, and identify the RP2D(s) and dosing schedule.
Secondary Objective:
- To characterize the pharmacokinetic profile of ARV-393 in plasma,
- To assess the preliminary anti-tumor activity of ARV-393.
View All Details
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Protocol Number:
012406
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Principal Investigator:
Matthew Matasar
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Phase:
Early Phase I
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
ARV-393
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Eligible participants aged ≥18 years.
- Have relapsed/refractory mature B-cell non-Hodgkin lymphoma (NHL) and ≥2 prior systemic therapies, or histologically confirmed AITL that has recurred or progressed following institutional standard-of-care therapy.
- Participants must also have ≥1 measurable lesion at study entry
- Eastern Cooperative Oncology Group performance status of 0 or 1,
- Freshly biopsied or archival tumor tissue available,
- Participants with adequate organ function,
- Participants must accept and follow pregnancy prevention guidance.
Exclusion Criteria:
- No prior allogeneic stem cell transplant or solid organ transplantation, Autologous stem cell transplant, must not have occurred ≤100 days, previous CAR T-cell therapy ≤60 days, radiotherapy ≤ 2 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, prior to ARV-393 treatment initiation.
- Participants must not have significant acute or chronic medical illness, including hypereosinophilic syndrome, active interstitial lung disease or pneumonitis, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.
- Participants with an inability to comply with listed prohibited treatments.
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.
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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
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Protocol Number:
012303
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Principal Investigator:
Matthew Matasar
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
Odronextamab(REGN1979)
REGN5837
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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, as described in the protocol. 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. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed 6. 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, as described in the protocol 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, as described in the protocol 5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol 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.
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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
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Protocol Number:
012316
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Principal Investigator:
Joanna Rhodes
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
JNJ-90014496
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
- Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
- Must meet the following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have had >= 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); Relapsed or refractory follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have had >= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
- Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL
- Measurable disease as defined by Lugano 2014 classification
- Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort
Exclusion Criteria:
- Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma
- Any prior solid organ or allogeneic stem cell transplantation
- 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, 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.
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the
Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP
Chemotherapy in Participants with Previously Untreated High-risk Large B-cell Lymphoma
(GOLSEEK-1)
- NCT06356129
Primary:
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the
Investigator.
Secondary (efficacy):
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to PFS as assessed by the IRAC.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to OR as assessed by the
Investigator.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma with respect to CMR as assessed by the
Investigator
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants
with untreated high-risk large B-cell lymphoma with respect to PFS24.
To evaluate the efficacy of golcadomide plus R-CHOP vs placebo-R-CHOP in participants
with untreated high-risk large B-cell lymphoma with respect to DoR.
To evaluate the efficacy of treatment with golcadomide plus R-CHOP vs placebo-RCHOP
on overall survival in participants with untreated high-risk large B-cell lymphoma with respect to PFS2.
To evaluate the exposure of CHOP cytotoxic components (cyclophosphamide, doxorubicin,
vincristine) in golcadomide plus R-CHOP vs placebo plus R-CHOP in participants with
untreated high-risk large-B-cell lymphoma with respect to relative dose intensity (RDI).
To compare the disease symptoms, functioning, and overall HRQoL of golcadomide plus R-CHOP vs placebo-RCHOP in participants with untreated high-risk large B-cell lymphoma as measured by the EORTC QLQ-C30 and the FACT-LymS
Secondary (Safety):
To evaluate the safety of golcadomide plus RCHOP vs placebo-R-CHOP in participants with untreated high-risk large B-cell lymphoma.
View All Details
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Protocol Number:
012407
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Principal Investigator:
Yun Kyoung Tiger
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
Golcadomide
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinalcenter B-cell (GCB) and activated B-cell (ABC) types]ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2double-hit lymphomas)iii) High-grade B-cell lymphoma, not otherwise specifiediv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)v) Epstein-Barr virus + DLBCL
- International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) > 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3.
- Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
- Must have Ann Arbor Stage II-IV disease.
Exclusion Criteria:
- Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
- Documented or suspected central nervous system (CNS) involvement by lymphoma.
- 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.
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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
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Protocol Number:
012320
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Principal Investigator:
Yun Kyoung Tiger
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
Belinostat
Pralatrexate (Folotyn)
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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 that it can be sent to the Sponsor (or designee) for later 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) patients are eligible only if Brentuximab Vedotin (BV) is not commercially approved for use, not available in the country or patient is contraindicated to receive BV.
- 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 and T-cell Follicular Helper (TFH) phenotype status must be available for documentation. 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 (ECOG) status ≤2 4. For Part 1 (Dose Finding) - Patient has adequate hematological, hepatic, and renal function as defined by: 1. Absolute neutrophil count ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of 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×upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) 5. 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 ≥ 1.5 × 10⁹/L or ≥ 1.0 × 10⁹/L if evidence of bone marrow involvement 2. Platelet count ≥100×10⁹/L or ≥ 75×10⁹/L if evidence of 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 x the upper limit of normal (ULN; AST/ALT ≤5×ULN if documented hepatic involvement with lymphoma) 5. Calculated creatinine clearance of ≥ 60 mL/min 6. UGT1A1 genotype has been characterized (see Belinostat dose modifications if abnormal) and must be available for documentation. 7. 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 8. Patient (male or female) is at least 18 years of age at the time of informed consent 9. Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 6 months after the last dose of study treatment. 10. 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:
A patient will not be eligible for inclusion if ANY of the criteria listed below apply: 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 if they can be treated with Brentuximab Vedotin (BV) 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 (i.e. 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 status on the following: 1. Has a known HIV-positive diagnosis with uncontrolled and detectable viral load 2. Has Hepatitis B or Hepatitis C virus diagnosis with uncontrolled and 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.
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A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination with Other Anticancer Agents in Participants with Mature B-Cell Malignancies
- NCT06564038
Primary Safety:
To assess the safety and tolerability SC AZD0486 as monotherapy (Cohort 1A) and in combination with acalabrutinib (Cohort 1B) in participants with R/R CLL/SLL who have received at least 1 prior line of therapy.
Secondary Efficacy:
To evaluate the preliminary efficacy of SC AZD0486 as monotherapy (Cohort 1A) and in combination with acalabrutinib (Cohort 1B) in participants with R/R CLL/SLL.
View All Details
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Protocol Number:
012408
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Principal Investigator:
Joanna Rhodes
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Phase:
Phase I/II
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
Chemotherapy single agent systemic
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Drugs Involved:
acalabrutinib (ACP-196)
AZD0486
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
Master Inclusion Criteria applicable to all substudies:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Contraception during treatment and at least 6 months after final dose.
- Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific Inclusion Criteria:
- Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
- SLL: at least 1 measurable site per Lugano.
- Absolute lymphocytes <10,000.
- Cohort 1A: at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTKi) and B-cell lymphoma 2 inhibitor (BCL2i).
- Cohort 1B: at least 1 prior line of therapy and is BTKi-sensitive.
Substudy 2 Specific Inclusion Criteria:
- MCL diagnosis per WHO.
- Clinical Stage II, III, or IV by Ann Arbor Classification.
- At least 1 measurable site per Lugano
- ALC < 10,000.
- Cohort 2A: Relapse or progressed after 2 or more lines of therapy including BTKi.
- Cohort 2B: Relapse or progressed after 1 or more line of therapy, not including a BTKi.
Substudy 3 Specific Inclusion Criteria:
- Large B-cell lymphoma per WHO 2022.
- R/R B-NHL after at least 1 prior line of therapy.
- International Prognostic Index (IPI) 2-5.
- At least 1 measurable site as per Lugano.
- Left ventricular ejection fraction (LVEF) >50%.
- Contraception at least 12 months after last dose of R-CHOP or 6 months after last dose of AZD0486.
Exclusion Criteria:
Master Exclusion Criteria applicable to all substudies:
- central nervous system (CNS) lymphoma.
- Surgery within 14 days of study drug.
- Clinically significant cardiovascular (CV) disease.
- Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
- Any anticancer therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
- Radiation therapy within 28 days.
- Prior CAR-T or auto-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
- Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
Substudy 1 Specific Exclusion Criteria:
- CLL transformation to more aggressive lymphoma
- Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 6 months, GI malabsorption, receiving vitamin K antagonist
Substudy 2 Specific Exclusion Criteria:
- Cohort 2B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 6 months, GI malabsorption, receiving vitamin K antagonist
Substudy 3 Specific Exclusion Criteria:
- Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL)
- Cumulative dose of anthracycline >150 mg/m2
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.
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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
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Protocol Number:
012107
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Principal Investigator:
Matthew Matasar
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
Gazyva (obinutuzumab)
Glofitamab
Tocilizumab
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- 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 one prior treatment regimen; no available treatment options that are expected to prolong survival (Part I and II); relapsed after or failed to respond to only one prior systemic treatment regimen (Part III)
- Must have at least one measurable 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 (ECOG) performance status of 0 or 1, or
- Life expectancy of >/= 12 weeks
- Adverse events from prior anti-cancer therapy must have resolved to Grade
- Adequate liver, hematological, 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 englumafusp alfa, 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 englumafusp alfa, 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 (ALC) or the presence of abnormal cells in the peripheral blood signifying circulating lymphoma cells (for some participants in Part III, ALC only)
- 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
- 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
- Autologous stem cell transplant 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 steroids 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.
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A Phase III, Open-Label, Multicenter, Randomized Study Evaluating Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma.
- NCT06084936
Primary Objective:
- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to PFS.
Secondary Objectives:
- To evaluate the efficacy of glofitamab monotherapy compared with an investigator s choice of BR or R-Len with respect to CRR.
- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to ORR.
- To evaluate the efficacy of glofitamab monotherapy compared with an investigators choice of BR or R-Len with respect to OS.
- To evaluate the health-related quality of life of participants treated with glofitamab monotherapy compared with an investigator s choice of BR or R-Len.
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Protocol Number:
012403
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Principal Investigator:
Matthew Matasar
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Phase:
Phase III
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
BENDAMUSTINE
Gazyva (obinutuzumab)
Glofitamab
LENALIDOMIDE
RITUXIMAB
Tocilizumab
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Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Life expectancy at least 12 weeks
- Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)
- Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease
- At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option
- Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment
- At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Negative HIV test at screening
- Adequate hematological function
Exclusion Criteria:
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer
- Leukemic, non-nodal MCL
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide
- Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
- Prior treatment with CAR-T cell therapy
- Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment
- Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
- Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Significant or extensive cardiovascular disease
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment
- Suspected or latent tuberculosis
- Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Known or suspected chronic active Epstein-Barr viral infection (EBV)
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Known history of progressive multifocal leukoencephalopathy (PML)
- Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better
- Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- Prior solid organ transplantation or allogenic stem cell transplant
- Eligibility for stem cell transplantation (SCT)
- Active autoimmune disease requiring treatment
- Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment
- Corticosteroid therapy within 2 weeks prior to first dose of study treatment
- Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis
- Clinically significant history of cirrhotic liver disease
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.
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A Randomized, Open-Label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants with Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma.
- NCT06500273
Primary:
- To assess the efficacy of cema-cel vs. observation in participants with MRD+ LBCL.
Secondary:
- To assess the overall safety profile of cema-cel and ALLO-647 in participants with MRD+ LBCL.
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Protocol Number:
012405
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Principal Investigator:
Matthew Matasar
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Phase:
Phase II
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy multiple agents systemic
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Drugs Involved:
ALLO-647
cema-cel (cemacabtagene ansegedleucel)
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Read Inclusion & Exclusion Criteria
Key Inclusion Criteria:
1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy. 3. Participant achieved CR, or PR suitable for observation at the end of first line therapy based on PET/CT evaluation 4. Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™, is positive. 5. Adult participants ≥18 years of age. 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. 7. Adequate hematological, renal, hepatic, pulmonary, and cardiac function 8. Non-hematologic toxicities related to prior therapy must be recovered to baseline or grade ≤1.
Key Exclusion Criteria:
1. LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL. 2. Prior treatment with anti-CD19 targeted therapies. 3. Anti-cancer treatment, including radiation, after end of treatment PET/CT and/or MRD testing is performed. 4. Active and clinically significant autoimmune disease. 5. Active systemic bacterial, fungal, or viral infections requiring systemic treatment (e.g., HIV). 6. History of another primary malignancy or bone marrow disorder (e.g., myelofibrosis, smoldering multiple myeloma) within 3 years prior to 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.
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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.
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Characterizing Lymphoma Survivors Experiences, Needs, and Preferences During the Transition to Cancer Survivorship: The Survivor Health Check Program Development Trial.
To assess information and support needs, preventive health behaviors symptoms, distress, preparedness for survivorship, and survivorship care experiences. To characterize level of interest in, preferred timing, potential delivery.
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Protocol Number:
132203
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Principal Investigator:
Sharon Manne
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Phase:
N/A
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Scope:
Local
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Applicable Disease Sites:
Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
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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 Objectives:
- 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.
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Protocol Number:
012321
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Principal Investigator:
Joanna Rhodes
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Phase:
Phase I
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Scope:
National
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Applicable Disease Sites:
Non-Hodgkin's Lymphoma
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Therapies Involved:
Chemotherapy single agent systemic
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Drugs Involved:
ABBV-101
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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. For EU only: Participant has an ECOG PS of 0 or 1.
- 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 or less than 12 weeks since achieving undetectable viral load in cases of prior active hepatitis C.
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.