Protocol Number: 04-C-0055
This study will use the following strategies to try to improve the outcome of stem cell transplants: -Patients will receive "non-myeloblative" chemotherapy that is easier for the body to tolerate (I think this last phrase should be deleted, as the period of immune suppression we use is similar to that conventionally utilized) -Patients will be randomly assigned to one of the following treatments to try to reduce the risk of developing serious GVHD: 1. Cyclosporin A plus Th2 cells (donated immune cells grown in a high concentration of an immune suppression drug called sirolimus); or 2. Cyclosporin A plus sirolimus treatment in tablet form; or 3. Cyclosporin A plus Th2 cells plus sirolimus treatment in tablet form. Patients between 18 and 75 years of age with non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia, acute myelogenous leukemia, acute lymphocytic leukemia, myelodysplastic syndrome, and myeloproliferative disorders may be eligible for this study. Candidates will be screened with physical examinations, diagnostic tests, and consultations with various specialists. Participants will have a central venous line placed into a major vein. This tube can stay in the body and be used the entire treatment period to deliver the donated stem cells and give medications, including chemotherapy and other drugs, antibiotics, and blood transfusions, and to withdraw blood samples. Treatment will start with chemotherapy, which will include the drugs fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone. Some patients may also receive an antibody called rituximab. Patients will receive one to three cycles of this treatment, depending on their response to the drugs. (One cycle consists of 4 days on drug therapy followed by a 17-day rest period.) Several days before the transplant procedure, patients will receive additional chemotherapy with cyclophosphamide and fludarabine, and 3 days later, the donor's stem cells will be infused. To help prevent GVHD, all patients will receive cyclosporine therapy for 6 months, beginning the day before the transplant. Depending on their treatment group, patients will also receive either: 1) Th2 cells the day after the transplant, 2) 4 days of sirolimus tablets, or 3) Th2 cells plus 4 days of sirolimus tablets. The average hospital stay for stem cell transplantation is 3 to 4 weeks. After discharge, patients will return for frequent follow-up visits for the first 3 months. Monthly visits will be scheduled for the next 3 months, then every 3 months for the next 18 months, and less frequently for a total of at least 5 years post-transplant.
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