-
A Long-Term Study for Participants Previously Treated With Ciltacabtagene Autoleucel.
- NCT05201781
To collect long-term follow-up data on delayed adverse events after administration of cilta-cel, and to characterize and understand the long-term safety profile of cilta-cel.
View All Details
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study
- Participants who have provided informed consent for this 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.
-
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
-
Protocol Number:
012406
-
Principal Investigator:
Matthew Matasar
-
Phase:
Early Phase I
-
Scope:
National
-
Applicable Disease Sites:
Non-Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
ARV-393
-
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.
-
A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.
- NCT06544265
Primary:
- To evaluate the safety of a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non- Hodgkin Lymphoma (B-NHL).
- To determine the recommended Phase 2 dose (RP2D) of SynKIR-310 in participants with relapsed/refractory B-NHL.
Secondary:
- To evaluate feasibility of administering a single IV infusion of SynKIR-310 in participants with relapsed/refractory B cell Non-Hodgkin Lymphoma (B-NHL).
- To evaluate preliminary efficacy measures of SynKIR-310 in participants with relapsed/refractory B-NHL.
View All Details
-
Protocol Number:
012504
-
Principal Investigator:
Matthew Matasar
-
Phase:
Phase I
-
Scope:
National
-
Applicable Disease Sites:
Non-Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
SynKIR-310
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Adult 18 years of age and older.
- Histologically confirmed diagnosis of B-NHL before enrollment.
- Must have received prior CAR T or were unwilling/unable to receive prior CAR T.
- Must have refractory or relapsed disease after receiving 2 prior lines of therapies.
- If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.
- If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease.
- Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Exclusion Criteria:
- Previously treated with any investigational agent within 30 days prior to screening.
- Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma
- Carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment.
- Any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level < 1.0 may also be permitted.
- Known immunodeficiency disease.
- History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.
- Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.
- Any active uncontrolled systemic fungal, bacterial or viral infection.Note: Other protocol defined Inclusion/Exclusion criteria may 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.
-
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
-
Principal Investigator:
Matthew Matasar
-
Phase:
Phase I
-
Scope:
National
-
Applicable Disease Sites:
Non-Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
Odronextamab(REGN1979)
REGN5837
-
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.
-
A Phase 1/2 Study of ABBV-383 in Combination with Anti-Myeloma Agents for the Treatment of Patients with Relapsed/Refractory Multiple Myeloma
- NCT06896916
Primary Objectives
To characterize the safety, toxicity, and tolerability of etentamig when co-administered with
iberdomide in subjects with RRMM.
To determine the recommended doses of etentamig and iberdomide combination treatment in
subjects with RRMM.
Secondary Objectives
To evaluate the preliminary anti-MM activity of etentamig when co-administered with
Iberdomide.
To characterize the PK and the immunogenicity of etentamig, as well as the PK of iberdomide
and its metabolite M12, when administered in combination as a regimen.
View All Details
-
Protocol Number:
012502
-
Principal Investigator:
Mansi R Shah
-
Phase:
Phase I/II
-
Scope:
National
-
Applicable Disease Sites:
Multiple Myeloma
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
ABBV-383
Etentamig
Iberdomide
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance of 0 to 1.
- Must have confirmed diagnosis of Relapsed/Refractory Multiple Myeloma (RRMM) after the participant's last treatment, as outlined in the protocol.
- All participants must have measurable diseases per central laboratory as outlined in protocol
Exclusion Criteria:
- Has received prior etentamig treatment.
- Prior exposure to BCMA-targeted therapy as noted in the protocol.
- Has received prior cereblon E3 ligase modulatory drug (CELMoD) (iberdomide or mezigdomide).
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.
-
A Phase 1/2, Open-Label, Dose-Escalation, Dose-Expansion Study of DSP- 5336 in Adult Acute Leukemia Patients with and without Mixed Lineage Leukemia (MLL) Rearrangement or Nucleophosmin 1 (NPM1) Mutation.
- NCT04988555
Phase 1: Dose-Escalation Objectives:
Primary Objectives:
- To assess the safety and tolerability of DSP-5336 in adult patients with relapsed or refractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or acute leukemia of ambiguous lineage.
- To determine the recommended Phase 2 dose (RP2D) of DSP-5336 based on the lowest dose of DSP-5336 that provides the maximum biologic and clinical effect, or the maximum tolerated dose (MTD), whichever is lower.
Secondary Objectives:
- To characterize the PK profiles of DSP-5336, including the PK profile in the presence of concomitant use of selected azoles, ie, posaconazole, voriconazole, fluconazole, or isavuconazonium (prodrug of isavuconazole).
- To evaluate the preliminary clinical activity of DSP-5336 in adult patients with AML, ALL, or acute leukemia of ambiguous lineage
- To determine the cardiac safety of DSP-5336 administered as a single agent by 12-lead safety and intensive ECG monitoring, and in the presence of azoles by 12-lead safety ECG monitoring
Exploratory Objectives:
- To assess minimal residual disease (MRD) status
- To assess the pharmacodynamic effect of DSP-5336
- To explore the PK exposure-response (ie, safety, efficacy, or biomarkers) relationship
- To identify the metabolite profile of DSP-5336 in plasma samples
- To identify potential biomarkers capable of predicting clinical efficacy and/or toxicity of DSP-5336
Phase 2: Dose-expansion objectives:
Primary Objective:
- To evaluate the clinical activity of DSP-5336 in adult patients with relapsed/refractory AML who have MLLr and/or NPM1m* by investigator assessment
Secondary Objectives:
- To evaluate the clinical activity of DSP-5336 by central assessment
- To further assess the safety and tolerability of DSP-5336
Exploratory Objectives:
- To assess MRD status
- To further assess the pharmacodynamic effect of DSP-5336
- To identify potential biomarkers capable of predicting clinical efficacy and/or toxicity of DSP-5336
View All Details
-
Protocol Number:
022303
-
Principal Investigator:
Neil Palmisiano
-
Phase:
Phase I/II
-
Scope:
National
-
Applicable Disease Sites:
Leukemia, other
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
DSP- 5336
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
Patients in the Phase 1 dose-escalation portion must have a diagnosis of relapsed orrefractory AML, ALL or acute leukemia of ambiguous lineage according to World HealthOrganization (WHO) 2022 classification, or, in the US only, a diagnosis of MDS or MM asdetermined by pathology review at the treating institution, and whose disease hasprogressed after available standard therapies known to be active for their AML, ALL, oracute leukemia of ambiguous lineage or, in the US, for MM or MDS.For patients with MDS (US only): 1. Patients with MDS must have IPSS-R risk categorization of "high" or "very high" at initial diagnosis or at study entry and have bone marrow blasts ≥ 5% (which is the definition of high-risk MDS in this study) 2. Patients with MDS must have relapsed or refractory disease and have exhausted available standard therapies including at least 2 cycles of treatment with HMAFor patients with MM (US only): 1. Have a confirmed diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) 2016 classification (Kumar, 2016) and whose disease has progressed after treatment with a minimum of 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 monoclonal antibody (mAb); patients must not be candidates for available therapies with established clinical benefit 2. Have measurable disease as defined in the protocol 3. Meet the laboratory parameters set in the protocolFor patients with relapsed/refractory AML in the venetoclax and azacitidine combinationcohort (in countries and sites where permitted): 1. Have MLLr or NPM1m. For patients with relapsed/refractory AML in the gilteritinib combination cohort (in countries and sites where permitted): 2. Have MLLr or NPM1m AND any of the following FLT3 mutations: FLT3-ITD, FLT3-TKD/D835 or FLT3-TKD/I836.Patients in the Phase 2 dose expansion portion of the study must have a confirmeddiagnosis of relapsed AML or ALL as determined by pathology review at the treatinginstitution, and who have ≥5% blasts by morphologic assessment in the bone marrow andfailed available standard therapies known to be active for their AML (Arm G and H) or ALL(Arm I). If the primary disease is a transformation from MDS or other hematologicmalignancies, patients need to receive available standard therapies for acute leukemiabefore enrolling this trial. Participants who are candidates for stem celltransplantation must have been offered this therapeutic option. Patients withextramedullary disease or peripheral blasts as the only manifestation of relapse are noteligible. 1. Patients must not have had prior exposure to a menin inhibitor 2. Patients for Arms G and H are limited to a total of 3 prior lines of therapy, with induction chemotherapy, consolidation chemotherapy, and stem cell transplantation with or without subsequent maintenance treatment considered to be 1 line. 3. Have a documented KMT2A (MLL)-fusion for Arm G and I or NPM1 mutation for Arm H assessed at relapse or immediately prior to the determination of refractory status. For Arms G and I, KMT2A genetic alterations other than fusions (eg, KMT2A-PTD, amplification, point mutation) are not permitted. 4. Be > 18 years of age. For countries and sites where approved, for DSP-5336 monotherapy, acute leukemia patients ≥12 years of age who weigh ≥40 kg may be enrolled. 5. ECOG < 2; For Phase 2 only, patients must have an ECOG performance status 0 or 1. 6. For monotherapy, WBC below 30,000/μ. For the combination arms, WBC count must be below 25,000/uL at enrollment and prior to starting treatment. (Hydroxyurea and steroids for cytoreduction purposes are allowed prior to enrollment and during study treatment) 7. Clearance of creatinine (CLcr) level ≥ 50 ml/min, assessed by the Cockcroft-Gault formula 8. Total bilirubin ≤1.5 the upper limit of normal (ULN) (or ≤2.0 ULN for patients with known Gilbert's syndrome) 9. Aspartate aminotransferase (AST) ≤3.0 times ULN 10. Alanine aminotransferase (ALT) ≤3.0 times ULN 11. Any prior treatment-related toxicities resolved to ≤Grade 1 prior to enrollment, with the exception of ≤Grade 2 alopecia or neuropathy. 12. Be willing to attend study visits as required by the protocol 13. Have an estimated life expectancy ≥3 months, based on the investigator's assessment 14. Females of childbearing potential must have a negative serum pregnancy test. 15. Must agree to use a highly effective contraception method or 2 acceptable methods of birth control (each partner must use one method) or use prevention of pregnancy measures (ie, agreement to refrain completely from heterosexual intercourse) during the study and for 6 months (for females and males alike) after the last dose of study drug, if male or female patient is of child-producing potential For sites in Japan only: Implantable hormonal contraceptives, a diaphragm with spermicide, cervical cap with spermicide and contraceptive sponge (spermicide is already in the contraceptive sponge) included in the barrier contraceptive method are not approved and cannot be used in Japan. 16. Have AML/ALL/MDS/MM bone marrow material suitable for genomic analysis of AML,ALL, MDS, or MM genetic alterations. Note: If a bone marrow material is insufficient, an alternative suitable tissue (ex: peripheral blood) must be provided.
Exclusion Criteria:
1. Has a left ventricular ejection fraction (LVEF) <50%, as determined by ECHO 2. Histological diagnosis of acute promyelocytic leukemia 3. Received systemic calcineurin inhibitors within 2 weeks prior to the first dose of DSP 5336 4. Have abnormal ECGs at screening that are clinically significant, such as (QTc >480 msec, with QTc corrected according to Fridericia's formula (QTcF). Note: In case of bundle branch block, QT interval correction can be performed. 5. Has an active anduncontrolled, bacterial, viral, or fungal infection requiring parenteral therapy. Note: Patients must be afebrile with negative blood cultures at least 72 hours prior to Cycle 1 Day 1. 6. Receives concurrent sensitive substrates with a narrow safety window or strong inhibitors or inducers of CYP3A4/5, including specifically: ketoconazole, isavuconazole and itraconazole. Other antifungals that are used as standard of care to prevent or treat infections are permitted. If a patient is on one of the excluded azole class antifungals, he/she can be taken off or switched to a permitted azole 7 or more days prior to first dose, then the patient could be allowed on study (Arm B) with approval of the medical monitor. 7. Received immunotherapy, including tumor vaccines and checkpoint inhibitors, within 42 days prior to the first dose of DSP-5336 8. Had major surgery within 28 days prior to the first dose of DSP-5336 9. Has active central nervous system leukemia. Patients with a history of any CNS leukemia involvement are excluded from Phase 2 Arms G and H. 10. Underwent HSCT or chimeric antigen receptor cell (CAR-T) therapy or other modified T-cell therapy within 60 days prior to the first dose of DSP-5336. Patients who have received >1 prior HSCT are excluded from Phase 2 Arms G and H. 11. Received a donor lymphocyte infusion within 28 days prior to the first dose of DSP-5336, or receiving immunosuppressive therapy post-HSCT at the time of screening, or with clinically active GVHD or GVHD requiring active medical intervention other than the use of topical steroids for ongoing cutaneous GVHD 12. Received antineoplastic agents (except hormonal therapies as adjuvant maintenance for breast or prostate cancers if a patient is taking before starting study treatment, and hydroxyurea given for controlling blast cells) or other investigational treatment within 14 days or 5 half-lives, whichever is shortest, prior to the first dose of DSP-5336 13. In the opinion of the treating investigator, have any concurrent conditions that could pose an undue medical hazard or interfere with interpretation of study results 14. Have a known detectable viral load for human immunodeficiency virus or hepatitis C, or evidence of hepatitis B surface antigen, all being indicative of active infection. For sites in Japan, Taiwan, and Korea only: Hepatitis B core (HBc) antibody or hepatitis B surface (HBs) antibody test should be performed if HBsAg is negative. If HBc antibody or HBs antibody test is positive, HBV DNA quantification test should be performed to confirm that HBV DNA is negative. 15. Have severe dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally, including the inability to swallow oral medication 16. Have cognitive, psychologic, or psychosocial impediment that would impair the ability of the patient o receive therapy according to the protocol, or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures 17. Are pregnant or breastfeeding or planning to become pregnant. Note: Patients who are breastfeeding may be enrolled if they interrupt breastfeeding prior to the first dose of any study drugs and do not feed the baby with breast milk expressed after receiving the first dose of any study drugs. Breastfeeding should not be resumed for at least 6 months after the last dose of study drug 18. Have any history or complication of interstitial lung disease (for sites in Japan in Phase 1 dose escalation only). For clinical sites in the EU, have a history of Grade ≥ 2 drug-induced interstitial lung disease or Grade ≥ 2 non-infectious pneumonitis within 6 months of starting study treatment. 19. Have a history of Torsades de Pointes 20. Received systemic calcineurin inhibitors within 4 weeks prior to the first dose of DSP-5336 21. Have plasma cell leukemia (>2.0 x 109 /L plasma cells in blood by standard differential) (for patients with MM only) 22. For patients intending to enroll into the combination cohort with gilteritinib: Patients must be gilteritinib-naïve or sensitive and have not received a FLT3 inhibitor in the relapsed refractory setting (prior FLT3 inhibitor in front line therapy is allowed) 23. Have a known intolerance of hypersensitivity reaction to components of the investigational medicinal product 24. Patients with LDH >500 U/L (>8.3 µkat/L) are excluded from Phase 2 Arms G and H
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.
-
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
-
Principal Investigator:
Joanna Rhodes
-
Phase:
Phase I
-
Scope:
National
-
Applicable Disease Sites:
Non-Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
JNJ-90014496
-
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 in Phase 1b: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma (FL) 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 FL 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 consistent with lymphoma after 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL; Phase 2 participants must have following: A diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy including an anthracycline containing chemotherapy regimen and an anti-CD20 monoclonal antibody; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; Cohort specific requirements:Cohort A (CAR-T Naïve): participants who have previously not received CAR-T cell therapyfor the treatment of lymphoma.Cohort B (CAR-T Exposed): participants who have relapsed disease and prior exposure toCAR-T cell therapy for the treatment of lymphoma.
- Measurable disease as defined by Lugano 2014 classification
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
Exclusion Criteria:
- History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
- 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 apheresis
- 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)
- Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
- Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and Burkitt-like lymphoma or Richter's transformation, Lymphomatoid granulomatosis, Plasmablastic lymphoma
- Any prior solid organ or allogeneic stem cell transplantation
- Autologous stem cell transplant within 12 weeks of apheresis; CAR-T exposed only: Prior CAR-T cell therapy within 12 weeks of apheresis
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.
-
A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax.
- NCT06317662
1. To evaluate the safety and tolerability of venetoclax in addition to a standard chemotherapy backbone and two cycles of blinatumomab in infants (aged 365 days or less at diagnosis) with newly diagnosed KMT2A-R ALL.
2. To determine in a randomized manner if the addition of venetoclax to Induction chemotherapy improves end of Induction minimal residual disease (MRD)- negative remission rates in infants with KMT2A-R ALL.2 cycles and must be maintained 4 weeks later.
View All Details
-
Protocol Number:
112507
-
Principal Investigator:
Marissa Botwinick
-
Phase:
Phase II
-
Scope:
National
-
Applicable Disease Sites:
Lymphoid Leukemia
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
Blinatumomab (AMG103)
Venetoclax (ABT-199)
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- All patients must be enrolled on APEC14B1 and consented to eligibility screening (part A) prior to treatment and enrollment on AALL2321
- Infants (aged 365 days or less) on the date of diagnosis are eligible; infants must be > 36 weeks gestational age at the time of enrollment
- Patients must have newly diagnosed B-acute lymphoblastic leukemia (B-ALL, 2017 World Health Organization [WHO] classification), also termed B-precursor ALL, or acute leukemia of ambiguous lineage (ALAL), which includes mixed phenotype acute leukemia. For patients with ALAL, the immunophenotype of the leukemia must comprise at least 50% B lineage
- Diagnostic immunophenotype: Leukemia cells must express CD19
Exclusion Criteria:
- Patients with Down Syndrome
- Patients with secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy
- Patients must not have received any cytotoxic chemotherapy for either the current diagnosis of infant ALL or for any cancer diagnosis prior to the initiation of protocol therapy, with the exception of:
- Steroid pretreatment:
- PredniSONE, prednisoLONE, or methylPREDNISolone for ≤ 72 hours (3 days) in the 7 days prior to enrollment. The dose of predniSONE, prednisoLONE or methylPREDNISolone does not affect eligibility
- Inhaled and topical steroids are not considered pretreatment
- Note: Pretreatment with dexamethasone in the 28 days prior to initiation of protocol therapy is not allowed with the exception of a single dose of dexamethasone used during or within 6 hours prior to or after sedation to prevent or treat airway edema. However, prior exposure to ANY steroids that occurred > 28 days before enrollment does not affect eligibility
- Intrathecal cytarabine or methotrexate:
- An intrathecal dose of cytarabine or methotrexate in the 7 days prior to enrollment does not affect eligibility
- Note: The preference is to defer the diagnostic lumbar puncture with intrathecal chemotherapy to day 1 of induction to allow for cytoreduction of circulating blasts and decrease the potential for central nervous system (CNS) contamination due to a traumatic tap. If done prior to day 1 of induction, these results will be used to determine CNS status
- Hydroxyurea:
- Pretreatment with ≤ 72 hours (3 days) of hydroxyurea in the 7 days prior to enrollment does not affect eligibility
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA) and National Cancer Institute (NCI) requirements for human studies must be met
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.
-
A Phase 2 Study of Inotuzumab Ozogamicin in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL).
- NCT02981628
Primary Aim:
To determine the morphologic response rate (complete response [CR] + complete response with incomplete hematologic recovery [CRi]) following one cycle of treatment with InO in children with relapsed or refractory CD22+ B-ALL.
1.2 Secondary Aims:
1.2.1 To determine the CR/CRi rate following 2 cycles of InO therapy.
1.2.2 To determine the safety of single agent InO administered at the adult
recommended phase 2 dose (RP2D) to pediatric patients with relapsed or
refractory CD22+ B-ALL.
1.2.3 To determine the level of minimal residual disease (MRD) by flow cytometry in responding patients.
1.2.4 To determine the incidence, severity, and outcomes of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver in patients during InO therapy and following subsequent treatment, including myeloablative hematopoietic stem cell transplantation (HSCT).
1.2.5 To estimate the 3-year event-free survival (EFS), 3-year overall survival (OS), and among responders, duration of CR/CRi for pediatric patients with relapsed or refractory B-ALL treated with InO.
1.3 Exploratory Aims:
1.3.1 To assess the level of CD22 surface expression and CD22 site density on leukemic blasts and correlate with clinical outcomes after treatment with InO.
View All Details
-
Protocol Number:
111707
-
Principal Investigator:
Archana Sharma
-
Phase:
Phase II
-
Scope:
National
-
Applicable Disease Sites:
Lymphoid Leukemia
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
Inotuzumab ozogamicin (CMC-544)
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- Patients must be >= 1 year and < 22 years of age at the time of enrollment
- Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
- NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study
- Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing >= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method
- Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended)
- In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
- Patients with one of the following:
- Second or greater relapse;
- Primary refractory disease with at least 2 prior induction attempts;
- First relapse refractory to at least one prior re-induction attempt
- Any relapse after HSCT (Cohort 1 ONLY)Patients with Down syndrome are eligible ONLY for Cohort 1 with:
- Any of above disease status, OR
- First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy
- Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs)
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2:
- Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment.
- A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate).
- A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment
- >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, >= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy.
- Note: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy.
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent. For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment.
- Anti-cancer agents that are antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria.
- Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction.
- Radiotherapy: >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given.
- Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed.
- Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
- A serum creatinine based on age/gender as follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
- Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L
Exclusion Criteria:
- Patients with any prior history of SOS irrespective of severity
- Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse
- Patients who have been previously treated with inotuzumab ozogamicin
- Patients who have previously received HSCT (Cohort 2 only)
- Patients with Down syndrome (Cohort 2 only)
- History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study
- Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 if Erwinia formulation of asparaginase can be obtained
- Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement
- Patients who are currently receiving another investigational drug
- Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy)
- Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications
- Patients who are currently receiving or plan to receive corticosteroids except as described below
- Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications
- Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient
- Patients who have an active uncontrolled infection defined as:
- Positive bacterial blood culture within 48 hours of study enrollment;
- Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability
- A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection
- Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline
- Active viral or protozoal infection requiring IV treatment
- Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome
- There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment
- Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin
- Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin
- Lactating females are not eligible unless they agree not to breastfeed their infants
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.
-
A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma.
- NCT06297226
Primary:
- To evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT.
Secondary:
- To further evaluate the efficacy of BMS-986393 in participants with quadruple class exposed R/R MM having received at least 4 prior LOT and 3 prior LOT.
View All Details
-
Protocol Number:
012402
-
Principal Investigator:
Mansi R Shah
-
Phase:
Phase II
-
Scope:
National
-
Applicable Disease Sites:
Multiple Myeloma
-
Therapies Involved:
Chemotherapy single agent systemic
-
Drugs Involved:
A Arlocabtagene Autoleucel (BMS-986393)
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria
- Documented diagnosis of multiple myeloma (MM) as per International Myeloma Working Group (IMWG) criteria.
- Received at least 4 classes of MM treatment [including immunomodulatory drug (IMiD), proteasome inhibitor (PI), anti CD38 mAb, anti-BCMA therapy, and at least 3 prior lines of therapy (LOT).
- Documented disease progression during or after their last anti-myeloma regimen as per IMWG 2016 criteria.
- Participants must have measurable disease during screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
- Active or history of central nervous system involvement with MM.
- Active systemic fungal, bacterial, viral, or other infection despite appropriate anti-infective treatment at the time of leukapheresis. Participants with severe infection, severe sepsis or bacteremia in the last 28 days prior to leukapheresis are excluded.
- Received any prior therapy directed at G protein-coupled receptor class C, group 5, member D (GPRC5D) or has received other prior treatment for MM without the required washout prior to leukapheresis.
- 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.
-
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.
- 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
-
Protocol Number:
012407
-
Principal Investigator:
Yun Kyoung Tiger
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Non-Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
Golcadomide
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria
- Histologically confirmed (per local evaluation) diagnosis of de novo, previouslyuntreated 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.
-
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease. (INCA34176-357)
- NCT06585774
Primary - To compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe cGVHD
View All Details
-
Protocol Number:
012411
-
Principal Investigator:
Ogechukwu Egini
-
Phase:
Phase III
-
Scope:
National
-
Applicable Disease Sites:
Hodgkin's Lymphoma
-
Therapies Involved:
Chemotherapy multiple agents systemic
-
Drugs Involved:
Axatilimab
Corticosteroids
-
Read Inclusion & Exclusion Criteria
Inclusion Criteria:
- ≥ 12 years of age at the time of informed consent.
- New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
- History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.
- Adequate hematologic function with ANC ≥ 0.5 × 109/L independent of growth factors for at least 7 days prior to study entry.
- Willingness to avoid pregnancy or fathering children.
Exclusion Criteria:
- Received more than 1 prior allo-HCT. Prior autologous HCT is allowed.
- Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
- Received more than 7 days of systemic corticosteroid treatment for cGVHD or unable to begin a prednisone dose ≥ 1.0 mg/kg per day (or methylprednisolone equivalent) for cGVHD.
- Received previous systemic treatment for cGVHD, including extracorporeal photopheresis.
- Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
- Prior treatment with CSF-1R targeted therapies.
- Active, uncontrolled bacterial, fungal, parasitic, or viral infection.
- Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-HCT was performed, including DLIs for the treatment of molecular relapse.
- History of acute or chronic pancreatitis.
- Active symptomatic myositis.
- History or current diagnosis of cardiac disease indicating significant risk of safety for participation in the study, such as uncontrolled or significant cardiac disease.
- Severe renal impairment, that is, estimated CrCl < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or endstage renal disease on dialysis.
- Impaired liver function, defined as total bilirubin > 1.5 × ULN and/or ALT and AST > 3 × ULN in participants with no evidence of liver cGVHD.
- Pregnant or breastfeeding.
Other protocol-defined Inclusion/Exclusion Criteria may 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.