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ECOG-ACRIN EA4151 for Mantle Cell Lymphoma - Clinical Trial

What is the 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).

What is the Condition Being Studied?

Mantle cell lymphoma

Who Can Participate in the Study?

Adults from age 18 to 70 years old who have:
- mantle cell lymphoma confirmed by histology
- have achieved a radiologic complete or partial remission
- must not be pregnant or nursing

Age Group
Adults

What is Involved?

If you agree to be in this study you will:
- Have CT (computed tomography) scan of the chest, abdomen, and pelvis
- Have 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
Medical Oncologist
Protocol Number
IRB:PRO00088210
NCT:NCT03267433
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698