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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 22, 2014