Purpose of this Study
We are doing this study to find out whether an autotransplant improves survival in mantle cell lymphoma patients who have achieved an excellent (minimal residual disease-negative) first complete remission (CR).
Who Can Participate?
Eligibility
Adults ages 18-70 who:
- Have mantle cell lymphoma confirmed by histology
- Have achieved a radiologic complete or partial remission
- Are not pregnant or nursing
- Have mantle cell lymphoma confirmed by histology
- Have achieved a radiologic complete or partial remission
- Are not pregnant or nursing
What is Involved?
If you agree to be in this study you will:
- Have a CT (computed tomography) scan of the chest, abdomen, and pelvis
- Have a PET (positron emission tomography) scan
- Have a bone marrow aspirate and biopsy
Be randomized (put into one of four groups by chance like a flip of a coin) and receive either:
-- Group 1 - complete the initial chemotherapy and receive an autotransplant
-- Group 2 - complete the initial chemotherapy and NOT receive autotransplant
-- Groups 3 & 4 - complete initial chemotherapy and undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab.
- Have a CT (computed tomography) scan of the chest, abdomen, and pelvis
- Have a PET (positron emission tomography) scan
- Have a bone marrow aspirate and biopsy
Be randomized (put into one of four groups by chance like a flip of a coin) and receive either:
-- Group 1 - complete the initial chemotherapy and receive an autotransplant
-- Group 2 - complete the initial chemotherapy and NOT receive autotransplant
-- Groups 3 & 4 - complete initial chemotherapy and undergo high-dose chemotherapy and autotransplant, followed by three years of maintenance rituximab.
Study Details
Full 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
Principal Investigator
Jeffrey
Crawford
Protocol Number
PRO00088210
NCT ID
NCT03267433
Phase
III
Enrollment Status
OPEN TO ACCRUAL