Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or … (NCT01880567) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma
United States113 participantsStarted 2013-07-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Relapsed/refractory MCL: Confirmed diagnosis of mantle cell lymphoma with cluster of differentiation (CD)20 and cyclin D1 through cyclin D3 positivity in tissue biopsy
* Relapsed/refractory MCL: Patient has relapsed and or refractory MCL and must have received at least one prior treatment regimen for their disease; patient with leukemia phase (peripheral blood involvement), leptomeningeal disease, cerebral spinal fluid (CSF) MCL, central nervous system (CNS) MCL, non-measurable disease, gastrointestinal (GI) MCL, or bone marrow (BM) MCL are also eligible
* Relapsed/refractory MCL: Understand and voluntarily sign an Institutional Review Board (IRB)-approved informed consent form
* Relapsed/refractory MCL: Patients with bone marrow or gastrointestinal (GI) only involvement are acceptable
* Relapsed/refractory MCL: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
* Relapsed/refractory MCL: Absolute neutrophil count (ANC) \>= 500/mm\^3; (patients who have bone marrow infiltration by MCL are eligible if their ANC is \>= 500/mm\^3 \[growth factor allowed\]; these patients should be discussed with either the principal investigator \[PI\] or Co-PI of the study for final approval)
* Relapsed/refractory MCL: Platelet count \>= 30,000/mm\^3 (transfusion to reach platelet count allowed); (patients who have bone marrow infiltration by MCL are eligible if their platelet level is equal to or \> than 15,000/mm\^3; these patients should be discu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is in Phase 2 and is no longer enrolling new patients, does the published safety and response data from this ibrutinib and rituximab combination apply to my specific situation — relapsed, refractory, or newly diagnosed as an older adult — and how does it compare to what standard treatment options can offer me today?
2The trial specifically tracks grade 3 or higher non-hematologic toxicities and grade 4 blood-related side effects as key safety markers — what are the most common serious side effects that showed up with this ibrutinib-rituximab combination, and how would those risks stack up against my current health condition?
3Given that this study enrolled both relapsed or refractory patients and older newly diagnosed patients, which of those groups does my situation most resemble, and does the response data from that specific group look promising enough to influence the treatment path you'd recommend for me?
4Since the trial is active but no longer recruiting, would the results from this study actually change what you'd prescribe me right now, or are there newer trials or approved combinations based on this research that I should be looking into instead?
5This trial required patients to be CD20 positive and CCND1, CCND2, or CCND3 positive — have my test results confirmed those markers, and does that change which treatments or trials you think are most worth discussing for my case?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response (complete response and partial response), assessed by the International Workshop Standardized Response Criteria for non-Hodgkin lymphoma
Timeframe: Up to 8 weeks
2
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
Timeframe: Up to 8 weeks
3
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
Timeframe: Up to 4 weeks
4
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