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

Not Enrolling
Chronic Myelogenous Leukemia, Multiple Myeloma, Non Hodgkin's Lymphoma, Hodgkin's Disease, Chronic Lymphocytic Leukemia

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Trial Information

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

Inclusion 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

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patient Response Rates of Acute or Chronic GVHD

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Richard Champlin, MD, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

December 2002

Related Keywords:

  • Chronic Myelogenous Leukemia
  • Multiple Myeloma
  • Non Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Chronic Lymphocytic Leukemia
  • CML
  • MM
  • NHL
  • HD
  • CLL
  • CD8 Depleted
  • Donor Lymphocyte
  • 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



UT MD Anderson Cancer Center Houston, Texas  77030