A Phase 2 interventional study of Ibrutinib and Laboratory Biomarker Analysis in CCND1 Positive, CCND2 Positive and CCND3 Positive, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
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.
783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.
This study's enrollment of 113 is above the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive ibrutinib PO daily on days 1-28 and rituximab 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.
Drug: Ibrutinib · Other: Laboratory Biomarker Analysis · Biological: Rituximab
Given PO
Also known as: BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765
Correlative studies
Given IV
Also known as: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Rituxan, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar IBI301, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, rituximab biosimilar TQB2303, rituximab-abbs, RTXM83, Truxima
Overall response (complete response and partial response), assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma
Overall response will be monitored using the Bayesian stopping boundaries calculated based on beta-binomial distribution.
Time frame: Up to 8 weeks
Overall response (complete response and partial response) in elderly patients with newly-diagnosed, untreated mantle cell lymphoma, assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma
Overall response will be monitored using the Bayesian stopping boundaries calculated based on beta-binomial distribution.
Time frame: Up to 8 weeks
Incidence of toxicity, defined as grade 3 or higher non-hematologic toxicity, grade 3 neutropenia, grade 4 hematologic toxicity, inability to administer full schedule and dose, or inability to receive treatment day 1 of course 2
Toxicity data will be summarized by frequency tables for all patients.
Time frame: Up to 4 weeks
Incidence of grade 3 or higher non-hematologic toxicity, grade 3 neutropenia, grade 4 hematologic toxicity, inability to administer full schedule and dose, or inability to receive treatment day 1 of course 2 in newly diagnosed elderly patients
Toxicity data will be summarized by frequency tables for all patients.
Time frame: Up to 4 weeks
Clinical benefit response (minimal response + overall response rate),
Will be assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma.
Time frame: Up to 6 years
Duration of response
Duration of response will be estimated using the method of Kaplan and Meier. Comparison by important subgroups will be made using the log-rank test. Cox proportional hazards will be employed for multivariate analysis.
Time frame: Up to 6 years
Progression-free survival
Progression-free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-events outcomes.
Time frame: Up to 6 years
Time to progression
Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-events outcomes.
Time frame: Up to 6 years
Overall survival
Overall survival will be estimated using the method of Kaplan and Meier. Comparison by important subgroups will be made using the log-rank test. Cox proportional hazards will be employed for multivariate analysis.
Time frame: Up to 6 years
Duration of response in elderly patients with newly diagnosed, untreated mantle cell lymphoma
Intend-to-treat analysis will be applied to the eligible patients.
Time frame: Up to 6 years
Progression-free survival in elderly patients with newly diagnosed, untreated mantle cell lymphoma
Intend-to-treat analysis will be applied to the eligible patients.
Time frame: Up to 6 years
Overall survival in elderly patients with newly diagnosed, untreated mantle cell lymphoma
Overall response will be monitored using the Bayesian stopping boundaries calculated based on beta-binomial distribution.
Time frame: Up to 6 years
Time to progression in elderly patients with newly diagnosed, untreated mantle cell lymphoma
Time frame: Up to 6 years
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center