CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
To evaluate response rates of acute or chronic Graft-versus-host disease (GVHD) following CD8 depleted DLI (Depleted Donor Lymphocyte Infusions) in patients with Chronic myelomonocytic leukemia (CMML), chronic lymphoid leukemia (CLL), Non-Hodgkin's lymphoma (NLM), Multiple Myeloma (MM) and Hodgkin's Lymphoma (HD).
- To evaluate safety and treatment related mortality after CD8 depleted DLI.
- To evaluate the time to onset of GVHD following DLI and response to GVHD treatment.
- To evaluate the incidence and timing of pancytopenia following DLI.
- To evaluate disease-free survival, overall survival and relapse rates in three cohorts of patients; early relapse CML, late relapse CML and lymphoproliferative disorders (HD, CLL, NHL and MM).
- To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions.
- To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4+ cells.
Chronic Myelogenous Leukemia
Non Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Biological: CD8 Depleted Donor Lymphocyte
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation|
- Patient Response Rates of Acute or Chronic GVHD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2001|
|Study Completion Date:||December 2002|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
Experimental: CD8 DLI
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
|Biological: CD8 Depleted Donor Lymphocyte|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038818
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard Champlin, MD, BS||UT MD Anderson Cancer Center|