CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00038818|
Recruitment Status : Terminated (Low accrual.)
First Posted : June 7, 2002
Last Update Posted : August 23, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myelogenous Leukemia Multiple Myeloma Non Hodgkin's Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia||Biological: CD8 Depleted Donor Lymphocyte||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation|
|Study Start Date :||May 2001|
|Actual Primary Completion Date :||December 2002|
|Actual Study Completion Date :||December 2002|
Experimental: CD8 DLI
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
|Biological: CD8 Depleted Donor Lymphocyte|
- Patient Response Rates of Acute or Chronic GVHD [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|