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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038818
Recruitment Status : Terminated (Low accrual.)
First Posted : June 7, 2002
Last Update Posted : August 23, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Myelogenous Leukemia Multiple Myeloma Non Hodgkin's Lymphoma Hodgkin's Disease Chronic Lymphocytic Leukemia Biological: CD8 Depleted Donor Lymphocyte Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Study Start Date : May 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Arm Intervention/treatment
Experimental: CD8 DLI
CD8 depleted DLI (Depleted Donor Lymphocyte Infusions)
Biological: CD8 Depleted Donor Lymphocyte

Primary Outcome Measures :
  1. Patient Response Rates of Acute or Chronic GVHD [ Time Frame: 2 years ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00038818

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038818     History of Changes
Other Study ID Numbers: ID00-335
First Posted: June 7, 2002    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by M.D. Anderson Cancer Center:
CD8 Depleted
Donor Lymphocyte

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