Protocol Number: 04-H-0112
Patients between 10 and 55 years of age with acute or chronic leukemia, myelodysplastic syndrome, or myeloproliferative syndrome may be eligible for this study. Prospective participants and their donors are screened with a medical history and physical examination, blood tests (including a test to match for genetic compatibility), breathing tests, chest and sinus x-rays, and tests of heart function. They also undergo a bone marrow biopsy and aspiration. For this procedure, done under local anesthetic, about a tablespoon of bone marrow is withdrawn through a needle inserted into the hipbone. Participants have dental and eye examinations. They undergo apheresis to collect lymphocytes for research studies. This procedure involves collecting blood through a needle in the arm, similar to donating a unit of blood. The lymphocytes are then separated and removed by a cell separator machine, and the rest of the blood is returned through a needle in the other arm. Before treatment begins, patients have a central intravenous line (flexible plastic tube) placed in a vein in the chest. This line remains in place during the stem cell transplant and recovery period for drawing and transfusing blood, giving medications, and infusing the donated cells. Preparation for the transfusion includes high-dose radiation and chemotherapy. Patients undergo total body irradiation in 8 doses given in two 30-minute sessions a day for 4 days. Eight days before the transplant, they begin taking fludarabine, and 3 days before the procedure they start cyclophosphamide. These are anti-cancer drugs that kill the cancer cells and prevent rejection of the donated cells. Patients with aggressive leukemia will also receive etoposide - a powerful anti-leukemic drug - 3 days before the transplant. While the patient is receiving chemotherapy, the donor receives daily injections for 5 days of G-CSF, a drug that moves stem cells from the bone marrow into the blood stream, and the white cells are then collected by apheresis. The day after chemotherapy is completed, the stem cells are infused into the patient through the central line. Patients usually stay in the hospital about 4 weeks after the transplant to recover. Treatment with cyclosporine, an immune-suppressing drug that helps prevents both rejection of donated cells and GVHD, is given 6 days before the transplant until 21 days post-transplant. It is then stopped to allow the donor immunity to function and is resumed on day 59 post-transplant (1 day before the first T-cell add-back). Patients return to the clinic for follow-up with various tests, treatments and examinations as required, with a minimum of visits at least once or twice a week for 2 to 4 months after the transplant; then at 4, 6, 9, and 12 months, and then yearly for at least 5 years.
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