Active — Not RecruitingPhase 3

Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

United States, Saudi Arabia689 participantsStarted 2017-11-27

Plain-language summary

This phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

Who can participate

Age range

18 Years – 70 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: * INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION) * Age \>= 18 and =\< 70 years * Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH). If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until step 1 registration; patients may register to step 0 without a documented Ki-67 index * In the opinion of the enrolling physician, patients must be felt to be a candidate for autologous stem cell transplantation * Patient may be about to begin, be receiving or have completed induction therapy within 120 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0 * For patients who have completed induction therapy and have been restaged, restaging evaluation must show status of partial (PR) or complete response (CR); post-induction patients with evidence of clinical disease progression are not eligible for preregistration * Up to two regimens of therapy (conventional chemotherapy, antibody therapy, or an oral regimen) are all…

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 Phase 3 trial is comparing stem cell transplant plus rituximab against rituximab maintenance alone specifically in patients whose mantle cell lymphoma has reached MRD-negative complete remission, can you tell me whether my test results show I've reached that same MRD-negative status, and what that would mean for which arm of this trial I might be considered for?
2This trial is active but no longer enrolling new patients — does that mean there's a chance I could still be considered, or should we focus entirely on finding other options that are currently open?
3Given that the central question in this trial is whether adding a stem cell transplant on top of rituximab maintenance actually improves overall survival in people who are already in complete remission, what does the current evidence outside this trial suggest about whether the transplant adds meaningful benefit for someone in my situation?
4A stem cell transplant is a major procedure with significant recovery demands — if we were to discuss the transplant arm as a treatment path, what would the realistic impact on my day-to-day life, work, and support needs look like during recovery compared to rituximab maintenance alone?
5Are there standard-of-care treatments available right now that follow a similar approach to one of these two arms, and how would you weigh pursuing one of those versus waiting to see results from this trial before making a decision?

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

Overall survival (OS) in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative complete remission (CR) who undergo auto-hematopoietic stem cell transplant (HCT) followed by rituximab versus (vs.) maintenance rituximab alone

Timeframe: Time between randomization and death from any cause, assessed up to 10 years

Trial details

NCT IDNCT03267433

SponsorECOG-ACRIN Cancer Research Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-01-31

View on ClinicalTrials.gov More Mantle Cell Lymphoma trials