CD8+ T Cell Depletion as Graft Versus Host Disease Prophylaxis After HLA-Matched Unrelated Donor Non-myeloablative Peripheral Blood Stem Cell Transplantation
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To assess the initial engraftment of HLA matched unrelated donor mobilized peripheral blood stem cells depleted of CD+8 cells.
Vincent T. Ho, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|