A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Progression-freeSurvival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapse and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Protocol: 
AAAQ8451
Phase: 
II

A Multi-center Randomized Phase II Study of the Impact of CD34+ Cell Dose on Progression-freeSurvival Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapse and Refractory Diffuse Large B-cell Lymphoma (DLBCL)

The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant. An autologous transplant is infusion of your own bone marrow cells (stem cells) following a high-dose of chemotherapy. Autologous transplant is the standard treatment for relapsed DLBCL or DLBCL that did not respond to initial chemotherapy. The treatment is meant to keep your lymphoma from coming back. Previous studies have suggested that the amount of your stem cells that you get at transplant may effect outcomes. This has not been proven in a randomized study. This phase II study will have patients assigned to either the experimental or standard arm through computer selection (assignment of being included either arm will not be known). The study will involve attempting to collect greater than 7 x106/kg stem cells. If you collect greater than 7 x106/kg stem cells then during your transplant you will receive either standard dosing arm or the experimental dosing arm. The lower cell dose in the study is the average cell dose patients like yourself currently receive. Potential advantages of lower dose include: less likelihood of reactions and having additional standard stem cell dose remaining for a potential second transplant.

Are you Eligible? (Inclusion Criteria)

1)Participants must be at least 18 yeas of age with relapsed or refractory de novo DLBCL.
2)Complete or partial response by IWG Working Group Criteria to maximum of one salvage line of chemotherapy without pre-HDT/ASCT salvage radiotherapy.
3)Eligible for high-dose therapy and autologous stem-cell rescue with eligibility criteria including, but not limited to:
- Cardiac ejection fraction of >/=45%
- Hemoglobin-adjustd diffusing capacity of carbon monoxide (DLCO) of >/=45% unless deemed translpant elegible by Pulmonary Service

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States