EA4151, A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma In Minimal Residual Disease-Negative First Complete Remission
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Lunning, Matthew
Maribeth Hohenstein, RN
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.