CD8+ T Cell Depletion for GVHD Prophylaxis After Peripheral Blood Stem Cell Transplantation
Study Details
Study Description
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 losing the anti-cancer effects.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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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 chemotherapy drugs (fludarabine and Busulfex) intravenously once each day for 4 days.
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On the third day after the patient has finished chemotherapy, the donor cells should arrive at Dana-Farber Cancer Institute and the lab will remove CD8 cells. Then the product will be given to the patient through a central line. If there are not enough stem cells in the donor product, then the CD8 cells will not be taken out, and the patient will get the whole product.
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Just before and after the transplant, the patient will also take tacrolimus and methotrexate to help prevent GVHD. Tacrolimus is a pill that will be taken orally two times a day. Methotrexate is a chemotherapy drug that is given intravenously on days 1, 3 and 6 after the transplant. In addition to the these drugs, participants will also take antibiotics to prevent infection and Filgrastim (G-CSF, neupogen) until their white blood cell counts are better.
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After the stem cell infusion, check-ups and blood tests will be performed at least once a week for 1 month. At about one month, a bone marrow biopsy to look for the donor's cells in the participants bone marrow will be performed. After the 1-month evaluation, the patient will be seen at least every 2 weeks with another bone marrow biopsy at 3-4 months after the transplant.
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After the patient is past 100 days since transplant, they will be followed in the clinic and have blood work done at least once a month until 6 months post transplant.
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The trial will end at 6 months after the transplant, but patients will be tracked for the rest of their life to look at long-term effects of this transplant.
Study Design
Outcome Measures
Primary Outcome Measures
- To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells. [2 years]
Secondary Outcome Measures
- To assess sustained engraftment [2 years]
- to determine the incidence of GVHD [2 years]
- to assess disease relapse. [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Hematologic malignancies that are candidates for allogeneic non-myeloablative stem cell transplantation
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AML or ALL in first or subsequent remission, or in resistant or untreated relapse with marrow blast < 20% of cellularity
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CML in first or subsequent chronic phase, or accelerated phase
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Myelodysplastic syndrome with < 20% marrow blasts
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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
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CLL RAI stage 2-4, which has progressed after initial fludarabine containing therapy, and BM involvement of < 20%
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Multiple myeloma stage II-III, in first or subsequent plateau phase with <20% BM plasma cells
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Available unrelated donor who is fully HLA matched at HLA-A,B,C and DRB1
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Age 18 or greater
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Performance status 0-2
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Life expectancy of > 100 days
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No HLA-matched related donor available
Exclusion Criteria:
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Myeloproliferative disorders other than CML
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MDS with myeloproliferative features, or CMML
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High grade Burkitts or Burkitts-like Non-Hodgkin's lymphoma
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Prior allogeneic stem cell transplant
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Active CNS involvement with disease
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Uncontrolled infection
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Pregnancy
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Evidence of HIV infection
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Heart failure uncontrolled my medications
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Total bilirubin > 2.0 mg/dl that is due to hepatocellular dysfunction
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AST > 2 x institutional upper limit of normal
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Serum creatinine > 2.0 mg/dl
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Brigham and Women's Hospital
Investigators
- Principal Investigator: Vincent T. Ho, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 05-151