CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation

Completed · Not applicable

Conditions studied: Hematologic Malignancy, AML, ALL, CML, Multiple Myeloma, NHL, Hodgkin's Lymphoma

In brief

The purpose of this trial is to determine if selectively removing only a small subset of T cells, called CD8+ T cells, is safe and if it can reduce the risk of graft versus host disease (GVHD) without losing the anti-cancer effects.

Key facts

Study ID

NCT00333190

Run by

Dana-Farber Cancer Institute

People needed

30

Starts

2005-09-01

Expected to finish

2009-03-01

Last updated by the study team

2012-03-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Hematologic malignancies that are candidates for allogeneic non-myeloablative stem cell transplantation
• AML or ALL in first or subsequent remission, or in resistant or untreated relapse with marrow blast < 20% of cellularity
• CML in first or subsequent chronic phase, or accelerated phase
• Myelodysplastic syndrome with < 20% marrow blasts
• NHL or Hodgkin's lymphoma in second or greater remission, or partial remission after salvage therapy, and in patients with marrow involvement, <20% involvement in BM
• CLL RAI stage 2-4, which has progressed after initial fludarabine containing therapy, and BM involvement of < 20%
• Multiple myeloma stage II-III, in first or subsequent plateau phase with <20% BM plasma cells
• Available unrelated donor who is fully HLA matched at HLA-A,B,C and DRB1
• Age 18 or greater
• Performance status 0-2
• Life expectancy of > 100 days
• No HLA-matched related donor available

You may not qualify if…

• Myeloproliferative disorders other than CML
• MDS with myeloproliferative features, or CMML
• High grade Burkitts or Burkitts-like Non-Hodgkin's lymphoma
• Prior allogeneic stem cell transplant
• Active CNS involvement with disease
• Uncontrolled infection
• Pregnancy
• Evidence of HIV infection
• Heart failure uncontrolled my medications
• Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction
• AST > 2 x institutional upper limit of normal
• Serum creatinine > 2.0 mg/dl

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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