ECOG-ACRIN EA4151 (Mantle Cell Lymphoma)

What is the Purpose of this Study?

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.
What is the Condition Being Studied?
Mantle Cell Lymphoma

Who Can Participate in this Study?

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

Age Group
Adults
Participating Institutions

What is Involved?

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).

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
George Barth Geller Distinguished Professor for Research in Cancer

Contacts
Protocol Number
IRB:
PRO00088210

NCT:
NCT03267433
ClinicalTrials.gov
View on ClinicalTrials.gov