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

This study has been terminated.

Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038818
  Purpose

Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and 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
Procedure: CD8 Depleted Donor Lymphocyte

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Cancer    Hodgkin's Disease    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   CD8 DEPLETED DONOR LYMPHOCYTE INFUSIONS FOR PATIENTS WITH RELAPSE OR RESIDUAL DISEASE FOLLOWING ALLOGENEIC STEM CELL TRANSPLANTATION

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

Estimated Enrollment:   90
Study Start Date:   May 2001
Estimated Study Completion Date:   December 2002

Detailed Description:

Primary Objectives: To evaluate response rates of acute or chronic GVHD following CD8 depleted DLI in patients with CMML, CLL, NHL, MM and 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.

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

Sponsors and Collaborators
M.D. Anderson Cancer Center
  More Information


Study ID Numbers:   ID00-335
First Received:   June 5, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00038818
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

Study placed in the following topic categories:
Leukemia, Lymphoid
Hodgkin's disease
Chronic myelogenous leukemia
Blood Protein Disorders
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Paraproteinemias
Hemostatic Disorders
Leukemia
Hemorrhagic Disorders
Multiple myeloma
Leukemia, Lymphocytic, Chronic, B-Cell
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Immunoproliferative Disorders
Hematologic Diseases
Blood Coagulation Disorders
Myeloproliferative Disorders
Vascular Diseases
Leukemia, Myeloid
Multiple Myeloma
Lymphatic Diseases
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Lymphoproliferative Disorders
Leukemia, B-Cell
Lymphoma, Non-Hodgkin
Bone Marrow Diseases
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2008




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