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

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PRIMARY OBJECTIVES: I. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first remission who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (w...

PRIMARY OBJECTIVES: I. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first remission who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (without auto-HCT). SECONDARY OBJECTIVES: I. To compare progression-free survival in MCL patients in MRD-negative first remission who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone. II. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive (or MRD-indeterminate) patients who undergo auto-HCT followed by 2 years of maintenance rituximab. III. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT. IV. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive prior to auto-HCT. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab intravenously (IV) once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. GROUP II: Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I. After completion of study treatment, patients are followed up every 3 and 6 months for 10 years.

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