Status:
COMPLETED
CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Hematologic Malignancy
AML
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
* The patient will be admitted to the hospital once a good donor is found for chemotherapy and stem cell transplant. The patient will remain in the hospital for 8 days and will receive two chemotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00333190
Start Date
September 1 2005
End Date
March 1 2009
Last Update
March 16 2012
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115