CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
NCT00038818 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3
Last updated 2012-08-23
Summary
Primary Objectives:
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).
Secondary Objectives:
* 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.
Conditions
- Chronic Myelogenous Leukemia
- Multiple Myeloma
- Non Hodgkin's Lymphoma
- Hodgkin's Disease
- Chronic Lymphocytic Leukemia
Interventions
- BIOLOGICAL
-
CD8 Depleted Donor Lymphocyte
Sponsors & Collaborators
-
Eligix
collaborator UNKNOWN -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Richard Champlin, MD, BS · UT MD Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-05-31
- Primary Completion
- 2002-12-31
- Completion
- 2002-12-31
Countries
- United States
Study Locations
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