Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Ibrutinib Plus Rituximab in Patients With Relapsed/Refractory Mantle Cell Lymphoma or Elderly Patients With Newly Diagnosed MCL
This phase II trial studies how well ibrutinib and rituximab work in treating patients with mantle cell lymphoma that has come back or has not responded to treatment or older patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving ibrutinib and rituximab may be an effective treatment for mantle cell lymphoma.
PRIMARY OBJECTIVES: I. To evaluate the response rate of ibrutinib plus rituximab in patients with relapsed and/or refractory mantle cell lymphoma (MCL). II. To evaluate the safety and response rate of ibrutinib plus rituximab in elderly patients (> 65) with newly-diagnosed, untreated MCL. SECONDARY OBJECTIVES: I. To further evaluate the toxicity profile of the combination of ibrutinib and rituximab in patients with relapsed and/or refractory MCL. II. To estimate the overall response rate (ORR); (partial response [PR] or better), the response duration (DOR), progression-free survival (PFS), time to progression (TTP) and overall survival (OS) in patients with relapsed and/or refractory MCL; clinical benefit response (CBR) = (minimal response [MR] + ORR) will also be evaluated. III. To estimate the response duration, PFS, time to progression (TTP), and OS in elderly patients (> 65) with newly-diagnosed, untreated MCL. EXPLORATORY OBJECTIVES: I. To correlate detected gene mutations and changes in gene and/or protein expression with response to treatment. OUTLINE: Patients receive ibrutinib orally (PO) daily on days 1-28 and rituximab intravenously (IV) over 4-8 hours on days 1, 8, 15, and 22 of course 1; on day 1 of courses 3-8; and on day 1 of every other course for all subsequent courses. Treatment with rituximab repeats every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Courses with ibrutinib repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
Recruiting |
NCT05976763 -
Testing Continuous Versus Intermittent Treatment With the Study Drug Zanubrutinib for Older Patients With Previously Untreated Mantle Cell Lymphoma
|
Phase 3 | |
Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
Recruiting |
NCT05471843 -
Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT05076097 -
A Study of OLR in First-line Treatment of Mantle Cell Lymphoma
|
Phase 2 | |
Active, not recruiting |
NCT03891355 -
Carfilzomib + Lenalidomide and Dexamethasone for BTK Inhibitors Relapsed-refractory or Intolerant MCL
|
Phase 2 | |
Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04883437 -
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
|
Phase 2 | |
Terminated |
NCT03585725 -
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
|
Early Phase 1 | |
Recruiting |
NCT02892695 -
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
|
Phase 1/Phase 2 | |
Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
Completed |
NCT01665768 -
Maintenance Rituximab With mTor Inhibition After High-dose Consolidative Therapy in Lymphoma
|
Phase 2 | |
Completed |
NCT01437709 -
Ofatumumab With or Without Bendamustine for Patients With Mantle Cell Lymphoma Ineligible for Autologous Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT00963534 -
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
|
Phase 1/Phase 2 | |
Completed |
NCT00921414 -
Mantel Cell Lymphoma Efficacy of Rituximab Maintenance
|
Phase 3 | |
Withdrawn |
NCT00541424 -
Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma
|
N/A | |
Completed |
NCT01456351 -
Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab
|
Phase 3 | |
Completed |
NCT01851551 -
Phase 1/2 Study of VSLI Plus Rituximab in Patients With Relapsed and/or Refractory NHL
|
Phase 1/Phase 2 | |
Completed |
NCT03295240 -
The Study of Bendamustine, Rituximab, Ibrutinib, and Venetoclax in Relapsed, Refractory Mantle Cell Lymphoma
|
Early Phase 1 |