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Title:
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
Protocol Number:
NCTNEA4151
Phase:
Phase III
Physician:
Nina Wagner-Johnston
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this research study is to determine whether an autotransplant improves survival in MCL patients who have achieved an excellent (MRD-negative) first complete remission (CR).
Eligibility:
Generally healthy adults with mantle cell lymphoma may be eligible.
Treatment:
This research study has three study groups. For Groups 1 and 2, a computer will assign you by chance to one of these treatment groups in the research study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. Only patients who are MRD-negative first complete remission may be assigned to Groups 1 and 2.• Group 1: You will be assigned autotransplant. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo high-dose chemotherapy and autotransplant, followed by 3 years of maintenance rituximab. Rituximab will be given by intravenous infusion (IV) through your vein. You will receive rituximab every 8 weeks for approximately 3 years. On the days you receive treatment, you will receive rituximab infusion for approximately 90 minutes.• Group 2: You will be assigned to not receive autotransplant. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo 3 years of maintenance rituximab. Rituximab will be given by intravenous infusion (IV) through your vein. You will receive rituximab every 8 weeks for approximately 3 years. On the days you receive treatment, you will receive rituximab infusion for approximately 90 minutes. Should your lymphoma come back at some future point, you would have the option of undergoing autotransplant, although that would not occur as part of the study.• Groups 3 and 4: You will be assigned to this group if you are in partial remission (PR), MRD indeterminate and/or your MRD test is still positive for lymphoma after initial chemotherapy. You will complete the initial chemotherapy as prescribed by your cancer physician. You will then undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab. Rituximab will be given by intravenous infusion (IV) through your vein. You will receive rituximab every 8 weeks for approximately 3 years. On the days you receive treatment, you will receive rituximab infusion for approximately 90 minutes.You will receive your initial chemotherapy as prescribed by your cancer physician. You will then possibly undergo auto transplant, depending which Group you are assigned to in the study. You will then complete three years of maintenance rituximab therapy. After you complete this treatment, your medical team will continue to monitor you for side effects and monitor you for evidence of a relapse of your lymphoma. We would like to receive information about your health from your doctor for up to 10 years from when you were enrolled on the study.
Population:
Adult
Last Update
03/05/2019 05:03 AM