CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation

Not Applicable

Terminated

• Conditions: Chronic Myelogenous Leukemia; Multiple Myeloma; Non Hodgkin's Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia
• Interventions: Biological: CD8 Depleted Donor Lymphocyte

• Registration Number: NCT00038818
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2002-06-05
• Study First Submitted QC: 2002-06-06
• Study First Posted: 2002-06-07
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD8 DLI	CD8 Depleted Donor Lymphocyte	CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)

Primary Outcome Measures

Name	Time	Method
Patient Response Rates of Acute or Chronic GVHD	2 years

Trial Locations

Locations (1)

UT MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States