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

This study has been terminated.
(Low accrual.)
Sponsor:
Collaborator:
Eligix
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038818
First received: June 5, 2002
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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.

Condition Intervention
Chronic Myelogenous Leukemia
Multiple Myeloma
Non Hodgkin's Lymphoma
Hodgkin's Disease
Chronic Lymphocytic Leukemia
Biological: CD8 Depleted Donor Lymphocyte

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Response Rates of Acute or Chronic GVHD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: May 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CD8 DLI
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
Biological: CD8 Depleted Donor Lymphocyte

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038818

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eligix
Investigators
Principal Investigator: Richard Champlin, MD, BS UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038818     History of Changes
Other Study ID Numbers: ID00-335
Study First Received: June 5, 2002
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
CML
MM
NHL
HD
CLL
CD8 Depleted
Donor Lymphocyte

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 17, 2014