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

CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation

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.

Study Overview

• Status: Terminated
• Conditions: Multiple Myeloma; Chronic Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Non Hodgkin's Lymphoma; Hodgkin's Disease
• Intervention / Treatment: Biological: CD8 Depleted Donor Lymphocyte

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• Patients of any age who have previously undergone allogeneic hematopoietic transplantation and have evidence of donor cell engraftment (>20% donor cell within three months of study entry)
• Expected survival >4 weeks

• CML patients with molecular, cytogenetic or hematologic relapse following allogeneic transplantation

  1. Molecular relapse- patients are eligible if bcr/abl is detectable at any time after day 180 post-allogeneic transplantation or if a negative bcr/abl PCR test was documented post-transplantation and the bcr/abl test is now positive by consecutive PCR determinations at least 4 weeks apart.
  2. Cytogenetic relapse-patients are eligible if standard cytogenetics demonstrate >10% t (9,22) positive cells greater than 60 days after myeloablative transplantation or 10% t (9,22) positive cells greater than 100 days after nonmyeloablative transplantation.
• CML patients with accelerated phase or blast crisis following allogeneic transplantation

• Patients with CLL, NHL, MM, or HD who have evidence of disease relapse or persistent disease at 60 days post-allo BMT and/or:

  1. MM- patients with a rising M-protein is detectable at 180 days post-transplant
  2. NHL - patients with molecular evidence of disease (bcl-2, t (4,11), etc.) at 180 days post transplant
  3. CLL, NHL or HD - patients with clear cut evidence of tumor growth at any time post-transplant are eligible
• Patients undergoing an HLA -identical or 5/6 antigen match transplant from a related or unrelated donor
• Patient's original donor must be available for lymphocyte donation
• There must be no evidence of active acute or graft-versus-host disease and patients should be off all immunosuppressive agents for, at least, two weeks prior to DLI. Patients on stable dose of methylprednisolone (<16 mg/d) without evidence of active GVHD are also eligible.
• Patients must have a Zubrod PS<2 (see appendix 7), Cr<2.5, bilirubin <3, and transaminases (SGPT, SGOT) <4x normal
• Patient must be able to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD8 DLI; CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)	Biological: CD8 Depleted Donor Lymphocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient Response Rates of Acute or Chronic GVHD	2 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Eligix
• Investigators: Principal Investigator: Richard Champlin, MD, BS, UT MD Anderson Cancer Center

Publications and helpful links

Helpful Links

• UT MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: May 1, 2001
• Primary Completion (Actual): December 1, 2002
• Study Completion (Actual): December 1, 2002

Study Registration Dates

• First Submitted: June 5, 2002
• First Submitted That Met QC Criteria: June 6, 2002
• First Posted (Estimate): June 7, 2002

Study Record Updates

• Last Update Posted (Estimate): August 23, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: NHL; MM; CLL; CML; HD; CD8 Depleted; Donor Lymphocyte
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Myeloproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Leukemia, Lymphoid; Leukemia, B-Cell; Lymphoma; Multiple Myeloma; Leukemia; Leukemia, Myeloid; Hodgkin Disease; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Other Study ID Numbers: ID00-335