A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma
NCT ID: NCT06192888
Last Updated: 2026-01-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
39 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-01-08
Study Completion Date
2028-01-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to find out whether the combination of glofitamab and lenalidomide is an effective treatment for relapsed or refractory Mantle Cell Lymphoma
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma
NCT05861050
Blastoid Variant Mantle Cell Lymphoma
Mantle Cell Lymphoma
Pleomorphic Variant Mantle Cell Lymphoma
RECRUITING
PHASE1/PHASE2
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
NCT06084936
Lymphoma
RECRUITING
PHASE3
Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
NCT06252675
Mantle Cell Lymphoma
RECRUITING
PHASE2
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
NCT07003295
Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
RECRUITING
PHASE2
A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.
NCT05833763
Mantle Cell Lymphoma
Mantle Cell Lymphoma Refractory
RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Mantle Cell Lymphoma
MCL
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants with Mantle Cell Lymphoma
Participants will be diagnosed with relapsed, refractory (R/R) mantle cell lymphoma (MCL) with prior BTK inhibitor (BTKi) failure
Group Type
EXPERIMENTAL
Glofitamab
Intervention Type
DRUG
IV Glofitamab
Obinutuzumab
Intervention Type
DRUG
IV Obinutuzumab
Lenalidomide
Intervention Type
DRUG
Oral Lenalidomide
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Glofitamab
IV Glofitamab
Intervention Type
DRUG
Obinutuzumab
IV Obinutuzumab
Intervention Type
DRUG
Lenalidomide
Oral Lenalidomide
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥18 years at the time of signing Informed Consent
* ECOG 0-2
* Histologic diagnosis confirmed as relapsed/refractory mantle cell lymphoma according to WHO guidelines, confirmed by the pathology department at the treating institution
* If the patient previously received CD20 directed therapy, there must be evidence of CD20 expression on neoplastic cells according to instutitional pathology department guidelines. This must be confirmed on a biopsy of Relapsed/Refractory Mantle Cell Lymphoma performed after receipt of the last CD20 directed therapy.
* At minimum 10 unstained slides or tissue block from tumor containing FFPE biospecimen sample from a Relapsed/Refractory Mantle Cell Lymphoma biopsy is required for tumor genomic profiling and MRD testing. If adequate archival tissue is not available, then a repeat biopsy will be required. This requirement can be waived (i.e. if site of disease is inaccessible) after discussion with the MSKCC Principal Investigator
* Tumor genomic profiling from a biopsy sample collected within 6 months of signing informed consent form is required. For MSK patients, this will be done via MSK IRB#12-245 (Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT)) within 6 months prior to signing Informed Consent form, and preferably repeated for patients who did not have IMPACT performed after discontinuing their last line of treatment. Patients at external sites will run genomic profiling per institutional guidelines. If sites do not have an approved assay available, they may send archival tissue to MSK. Details included in lab manual
* Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. Prior BTKi failure is required. BTKi failure is defined as progression of disease during BTKi therapy or patients must have progressed or relapsed after completing BTK inhibitor therapy, or failed to achieve a PR following 12 weeks of BTK inhibitor therapy.
* Presence of evaluable disease
* Adequate bone marrow and organ function:
* Absolute neutrophil count (ANC) ≥1,000 cells/mcL, unless felt to be secondary to underlying MCL (minimum ANC 500 cells/mcL)
* Hgb ≥ 8 g/dL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum Hgb 7.0 g/dL) without transfusional support for 7 days before first treatment)
* Platelet count ≥50,000 cells/mcL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum platelet count 25,000 cells/mcL) without transfusional support for 7 days before first treatment)
* Renal function assessed by calculated Cockcroft-Gault creatinine clearance (CrCl; see Appendix A) ≥ 30 ml/min. See lenalidomide Treatment Plan, (Table 10-1), for lenalidomide dose adjustment for CrCl ≥ 30 mL/min and \< 60 mL/min
* Adequate hepatic function as determined by:
* Total bilirubin ≤1.5X upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 x ULN
* Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN or ≤ 5 x ULN in cases of documented liver involvement.
* Willingness to receive adequate prophylaxis and/or therapy for thromboembolic events, unless contraindicated in the opinion of the investigator.
* Willingness to undergo confirmatory procedures for assessment of disease status and experimental studies as required by protocol, including bone marrow (BM) aspiration/biopsy and gastrointestinal endoscopy/colonoscopy with biopsy, and/or biopsy of other tissue when appropriate and medically feasible.
* Each patient must sign an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate.Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be eligible.
* Willingness of patients who can become pregnant, according to Revlimid/lenalidomide Risk Evaluation and Mitigation Strategy (REMS) criteria, to undergo pregnancy testing in accordance with REMS requirements
* Willingness of all patients to complete surveys and adhere to contraception requirements mandated by the Revlimid/lenalidomide REMS
* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 2 months after the final dose of glofitamab, 28 days after the last dose of lenalidomide, 18 months after the last dose of obinutuzumab.
* For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of lenalidomide, 6 months after the last dose of obinutuzumab. Men must refrain from donating sperm during this same period.
* Life expectancy ≥ 12 weeks as determined by patient's primary clinician
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1.
* Clinically significant history of liver disease, including active viral or other hepatitis or current uncontrolled alcohol use disorder that would compromise patient's ability to safely participate in the trial, per clinician's judgment
* Active central nervous system (CNS) involvement with lymphoma, either parenchymal or leptomeningeal
* Presence of ≥Grade 2 toxicity (CTCAE v5.0) due to prior cancer therapy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
* History of hypersensitivity to compounds of similar biological or chemical composition to IMiDs® and/or the excipients contained in the study drug formulations
* Previous treatment with bispecific antibody therapy directed against CD20 and CD3
* Previous treatment with lenalidomide or other IMiDs® within 12 months of treatment initiation on this study.
* Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy
* Autologous stem cell transplantation (ASCT) within the period ≤3 months prior to the signing of the informed consent form. Patients with a more distant history of ASCT must exhibit full hematologic recovery before enrollment into the study
* Allogenic stem cell transplantation within the period of ≤3 months prior to signing of the Informed Consent form, evidence of graft-versus-host-disease (GVHD), or receiving active immunosuppression for GVHD.
* A history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
* Concurrently use other anticancer or experimental treatments
* Administration of a live vaccine within 28 days prior to the start of study treatment (Cycle 1 Day 1).
* Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment
* Corticosteroid therapy within 2 weeks prior to first dose of study treatment, with the following exceptions:
* Short course systemic corticosteroids (total daily dose equivalent of prednisone 100mg or dexamethasone 20 mg) is permissible for disease control, improvement of performance status, or non-cancer indication if administered for ≤ 5 days, and must be discontinued prior to study initiation of study treatment. When clinically indicatedfeasible, tumor assessments such as imaging and biopsies should be performed prior to steroid administration, though this is not required for enrollment.
* Chronic corticosteroid use of ≤20 mg prednisone equivalent per day, on a stable dose for ≥4 weeks prior to registration.
* Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety, or affect compliance with the protocol or interpretation of results.
* Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV or Objective Assessment Class C or D cardiac disease, myocardial infarction ≤ 6 months from registration, symptomatic congestive heart failure, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
* Known or suspected chronic active Epstein-Barr viral (CAEBV) infection or reactivation of a latent infection prior to enrollment. CAEBV is a progressive disease with markedly elevated levels of EBV DNA in the blood and infiltration of organs by EBV-positive lymphocytes along with fever, lymphadenopathy, splenomegaly, EBV hepatitis and/or pancytopenia.
* Participants with detectable EBV titers (quantified using Real-Time qPCR) that are below the level of quantification are eligible.
* Participants with an EBV titer of \<500 IU/mL are eligible, provided that levels are measured monthly for the first 3 months. If there is a rise in EBV levels \>500 IU/mL during treatment, management and any therapy should follow local guidelines.
* ECOG 0-2
* Histologic diagnosis confirmed as relapsed/refractory mantle cell lymphoma according to WHO guidelines, confirmed by the pathology department at the treating institution
* If the patient previously received CD20 directed therapy, there must be evidence of CD20 expression on neoplastic cells according to instutitional pathology department guidelines. This must be confirmed on a biopsy of Relapsed/Refractory Mantle Cell Lymphoma performed after receipt of the last CD20 directed therapy.
* At minimum 10 unstained slides or tissue block from tumor containing FFPE biospecimen sample from a Relapsed/Refractory Mantle Cell Lymphoma biopsy is required for tumor genomic profiling and MRD testing. If adequate archival tissue is not available, then a repeat biopsy will be required. This requirement can be waived (i.e. if site of disease is inaccessible) after discussion with the MSKCC Principal Investigator
* Tumor genomic profiling from a biopsy sample collected within 6 months of signing informed consent form is required. For MSK patients, this will be done via MSK IRB#12-245 (Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT)) within 6 months prior to signing Informed Consent form, and preferably repeated for patients who did not have IMPACT performed after discontinuing their last line of treatment. Patients at external sites will run genomic profiling per institutional guidelines. If sites do not have an approved assay available, they may send archival tissue to MSK. Details included in lab manual
* Previously treated with at least one prior line of systemic therapy for mantle cell lymphoma. Prior BTKi failure is required. BTKi failure is defined as progression of disease during BTKi therapy or patients must have progressed or relapsed after completing BTK inhibitor therapy, or failed to achieve a PR following 12 weeks of BTK inhibitor therapy.
* Presence of evaluable disease
* Adequate bone marrow and organ function:
* Absolute neutrophil count (ANC) ≥1,000 cells/mcL, unless felt to be secondary to underlying MCL (minimum ANC 500 cells/mcL)
* Hgb ≥ 8 g/dL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum Hgb 7.0 g/dL) without transfusional support for 7 days before first treatment)
* Platelet count ≥50,000 cells/mcL without transfusional support for 7 days before first treatment, unless felt to be secondary to underlying MCL (minimum platelet count 25,000 cells/mcL) without transfusional support for 7 days before first treatment)
* Renal function assessed by calculated Cockcroft-Gault creatinine clearance (CrCl; see Appendix A) ≥ 30 ml/min. See lenalidomide Treatment Plan, (Table 10-1), for lenalidomide dose adjustment for CrCl ≥ 30 mL/min and \< 60 mL/min
* Adequate hepatic function as determined by:
* Total bilirubin ≤1.5X upper limit of normal (ULN) unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma. Patients with Gilbert's syndrome or documented liver involvement by lymphoma may be included if their total bilirubin is ≤ 5 x ULN
* Aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤ 3 x ULN or ≤ 5 x ULN in cases of documented liver involvement.
* Willingness to receive adequate prophylaxis and/or therapy for thromboembolic events, unless contraindicated in the opinion of the investigator.
* Willingness to undergo confirmatory procedures for assessment of disease status and experimental studies as required by protocol, including bone marrow (BM) aspiration/biopsy and gastrointestinal endoscopy/colonoscopy with biopsy, and/or biopsy of other tissue when appropriate and medically feasible.
* Each patient must sign an informed consent form indicating that he or she understands the purpose of and procedures required for the study and are willing to participate.Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be eligible.
* Willingness of patients who can become pregnant, according to Revlimid/lenalidomide Risk Evaluation and Mitigation Strategy (REMS) criteria, to undergo pregnancy testing in accordance with REMS requirements
* Willingness of all patients to complete surveys and adhere to contraception requirements mandated by the Revlimid/lenalidomide REMS
* For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of \<1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 2 months after the final dose of glofitamab, 28 days after the last dose of lenalidomide, 18 months after the last dose of obinutuzumab.
* For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 2 months after the final dose of glofitamab, 28 days after last dose of lenalidomide, 6 months after the last dose of obinutuzumab. Men must refrain from donating sperm during this same period.
* Life expectancy ≥ 12 weeks as determined by patient's primary clinician
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to cycle 1, day 1.
* Clinically significant history of liver disease, including active viral or other hepatitis or current uncontrolled alcohol use disorder that would compromise patient's ability to safely participate in the trial, per clinician's judgment
* Active central nervous system (CNS) involvement with lymphoma, either parenchymal or leptomeningeal
* Presence of ≥Grade 2 toxicity (CTCAE v5.0) due to prior cancer therapy
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
* Patient with history of confirmed progressive multifocal leukoencephalopathy (PML)
* History of hypersensitivity to compounds of similar biological or chemical composition to IMiDs® and/or the excipients contained in the study drug formulations
* Previous treatment with bispecific antibody therapy directed against CD20 and CD3
* Previous treatment with lenalidomide or other IMiDs® within 12 months of treatment initiation on this study.
* Documented refractoriness to lenalidomide, defined as no response (PR or CR) within 6 months of therapy
* Autologous stem cell transplantation (ASCT) within the period ≤3 months prior to the signing of the informed consent form. Patients with a more distant history of ASCT must exhibit full hematologic recovery before enrollment into the study
* Allogenic stem cell transplantation within the period of ≤3 months prior to signing of the Informed Consent form, evidence of graft-versus-host-disease (GVHD), or receiving active immunosuppression for GVHD.
* A history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
* Concurrently use other anticancer or experimental treatments
* Administration of a live vaccine within 28 days prior to the start of study treatment (Cycle 1 Day 1).
* Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks or five half-lives (whichever is shorter) prior to first dose of study treatment
* Corticosteroid therapy within 2 weeks prior to first dose of study treatment, with the following exceptions:
* Short course systemic corticosteroids (total daily dose equivalent of prednisone 100mg or dexamethasone 20 mg) is permissible for disease control, improvement of performance status, or non-cancer indication if administered for ≤ 5 days, and must be discontinued prior to study initiation of study treatment. When clinically indicatedfeasible, tumor assessments such as imaging and biopsies should be performed prior to steroid administration, though this is not required for enrollment.
* Chronic corticosteroid use of ≤20 mg prednisone equivalent per day, on a stable dose for ≥4 weeks prior to registration.
* Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety, or affect compliance with the protocol or interpretation of results.
* Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV or Objective Assessment Class C or D cardiac disease, myocardial infarction ≤ 6 months from registration, symptomatic congestive heart failure, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
* Known or suspected chronic active Epstein-Barr viral (CAEBV) infection or reactivation of a latent infection prior to enrollment. CAEBV is a progressive disease with markedly elevated levels of EBV DNA in the blood and infiltration of organs by EBV-positive lymphocytes along with fever, lymphadenopathy, splenomegaly, EBV hepatitis and/or pancytopenia.
* Participants with detectable EBV titers (quantified using Real-Time qPCR) that are below the level of quantification are eligible.
* Participants with an EBV titer of \<500 IU/mL are eligible, provided that levels are measured monthly for the first 3 months. If there is a rise in EBV levels \>500 IU/mL during treatment, management and any therapy should follow local guidelines.
Exclusion Criteria
* Investigational agent or anticancer therapy within 5 half-lives prior to start of study therapy except therapeutic monoclonal antibody treatment must be discontinued a minimum of 4 weeks prior to study therapy. An exception is BTKi therapy, which can be continued to prevent disease flare up until 1 day prior to start of study therapy.
* Major surgery within 4 weeks prior to planned start of study therapy.
* Radiotherapy within 7 days of the start of study therapy.
* CART infusion within 30 days prior to Day 1 of Cycle 1
* Active hepatitis B or C, as defined below:
* HBV surface antigen positive
* HBV surface antigen negative, HBV core antibody positive and detectable HBV viral DNA. Note: subjects who are HBV core antibody positive and viral DNA negative are eligible. (Prophylactic anti-viral treatment is required for subjects who are HBV core antibody positive)
* HCV antibody positive and HCV RNA positive.
* History of human immunodeficiency virus (HIV) unless all of the following criteria are met:
* CD4+ T cell count ≥ 250 cells/mcL
* No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 1 year prior to signing Informed Consent Form
* Stable (no change in regimen for ≥ 4 weeks) and effective antiretroviral regimen, and HIV viral load \< 400 copies/mL within 4 weeks prior to signing Informed Consent form
* Active concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix or breast, adequately treated lentigo maligna melanoma, or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy previously treated for curative intent is permitted.
* Major surgery within 4 weeks prior to planned start of study therapy.
* Radiotherapy within 7 days of the start of study therapy.
* CART infusion within 30 days prior to Day 1 of Cycle 1
* Active hepatitis B or C, as defined below:
* HBV surface antigen positive
* HBV surface antigen negative, HBV core antibody positive and detectable HBV viral DNA. Note: subjects who are HBV core antibody positive and viral DNA negative are eligible. (Prophylactic anti-viral treatment is required for subjects who are HBV core antibody positive)
* HCV antibody positive and HCV RNA positive.
* History of human immunodeficiency virus (HIV) unless all of the following criteria are met:
* CD4+ T cell count ≥ 250 cells/mcL
* No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 1 year prior to signing Informed Consent Form
* Stable (no change in regimen for ≥ 4 weeks) and effective antiretroviral regimen, and HIV viral load \< 400 copies/mL within 4 weeks prior to signing Informed Consent form
* Active concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix or breast, adequately treated lentigo maligna melanoma, or localized prostate cancer. Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy previously treated for curative intent is permitted.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genentech, Inc.
INDUSTRY
Sponsor Role
collaborator
Memorial Sloan Kettering Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anita Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dana Farber Cancer Institute (Data Collection and Specimen Analysis)
Boston, Massachusetts, United States
Site Status
RECRUITING
Mayo Clinic (Data Collection Only)
Rochester, Minnesota, United States
Site Status
RECRUITING
Washington University (Data Collection Only)
St Louis, Missouri, United States
Site Status
ACTIVE_NOT_RECRUITING
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Site Status
RECRUITING
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States
Site Status
RECRUITING
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Site Status
RECRUITING
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States
Site Status
RECRUITING
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, United States
Site Status
RECRUITING
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Site Status
RECRUITING
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United States
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christine Ryan, MD
Role: primary
617-632-6844
Yucai Wang, MD
Role: primary
507-284-2511
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Anita Kumar, MD
Role: primary
646-608-3780
Related Links
Access external resources that provide additional context or updates about the study.
http://www.mskcc.org
Memorial Sloan Kettering Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-319
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
The Efficacy and Safety of Glofitamab in Combination With PD-1 Antibody and Lenalidomide in Patients With Relapsed/Refractory Large B-cell Lymphoma (LBCL) With TP53 Aberrations: A Prospective, Multicenter, Phase II Clinical Study
NCT07240194
RECRUITING
PHASE2
A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma
NCT06656221
NOT_YET_RECRUITING
PHASE2
A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma
NCT05788289
TERMINATED
PHASE2
A Phase II Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma
NCT06558604
RECRUITING
PHASE2
Glofit and Obin in Follicular Lymphoma and Marginal Zone Lymphoma
NCT05783596
ACTIVE_NOT_RECRUITING
PHASE2
Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab
NCT00609869
COMPLETED
PHASE2
Sequential Chemotherapy and Lenalidomide Followed by Rituximab and Lenalidomide Maintenance for Untreated Mantle Cell Lymphoma
NCT02633137
COMPLETED
PHASE2
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
NCT01437709
COMPLETED
PHASE2
Pacritinib in Combination With a BTK Inhibitor for the Treatment of Patients With Relapsed or Refractory Mantle Cell Lymphoma
NCT06675123
RECRUITING
PHASE1
Combination Chemotherapy With or Without Rituximab in Treating Patients With Mantle Cell Lymphoma
NCT00053092
COMPLETED
PHASE2
Lenalidomide and Rituximab in the Treatment of Relapsed Mantle Cell Lymphoma (MCL) and Diffuse Large B-Cell Lymphoma
NCT00294632
COMPLETED
PHASE1/PHASE2
A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04408638
ACTIVE_NOT_RECRUITING
PHASE3
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma
NCT06357676
NOT_YET_RECRUITING
PHASE1/PHASE2
The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study
NCT06656234
NOT_YET_RECRUITING
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
NCT06572618
RECRUITING
PHASE2
A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma
NCT06213311
RECRUITING
PHASE2
A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04657302
COMPLETED
PHASE1
Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma
NCT01729104
TERMINATED
PHASE1
Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
NCT01476787
COMPLETED
PHASE3
S1106 Rituximab With Combination Chemotherapy or Bendamustine Hydrochloride Followed by Consolidation Chemotherapy and Stem Cell Transplantation in Older Patients With Previously Untreated Mantle Cell Lymphoma
NCT01412879
COMPLETED
PHASE2
A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
NCT06806033
RECRUITING
PHASE2
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
NCT01996865
COMPLETED
PHASE3
Glofitamab Combined With CAR-T Therapy in R/R DLBCL
NCT07326371
NOT_YET_RECRUITING
PHASE2
Glofitamab in Chinese Patients With R/R DLBCL
NCT06481826
RECRUITING
Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma
NCT01472562
COMPLETED
PHASE2