T-Reg Cell Kinetics, Stem Cell Transplant, REGALE

To participate in this transplant, the patient will need to have a central line. Before the transplant we will test the blood for viruses which can cause problems after the transplant. These viruses include Hepatitis B, cytomegalovirus and HIV. If the patient is positive for the AIDS virus, they will not be able to undertake the transplant. Standard therapy: The patient will be given 6 doses of chemotherapy with a drug called Ara C in high doses (every 12 hours) which will begin 8 days before the stem cell transplant. Then, another chemotherapy drug called cyclophosphamide will be given in high doses by vein for two days on the 7th and 6th days before the transplant. A drug called MESNA will be given with cyclophosphamide. MESNA is used to decrease the side effects caused by cyclophosphamide. The patient will also receive an antibody called Campath (each day for 4 days before the transplant) to help destroy the immune system so that there is less host resistance to the growth of the donor cells. Radiation treatment will be given to the entire body on each day for 4 days before transplant. This will be given 2 times a day for 4 days. The chemotherapy and radiation treatment will last 8 days. If the patient has a diagnosis of T-cell Lymphoma, they will not be given the Ara-C. Extra bone marrow tests may be recommended by the physician to check on the patients condition, especially if the marrow is slow to grow. The day after the radiation treatment is completed; the patient will receive the healthy stem cells by vein. Once in the bloodstream, these stem cells will go to the bone marrow and should begin to grow. In prevention of GvHD, the patient will also receive medicine called FK506 as well as low dose methotrexate. The FK506 will be given intravenously initially starting 2 days before the transplant and later by mouth (when they are able to take oral medications). This drug will be given each day for several weeks. Four doses of low dose methotrexate will be given intravenously. The methotrexate will be given on the day after the transplant, 3, 6 and 11 days after the transplant. If the GVHD cannot be controlled with FK506, other medicines may need to be given. The doctor will describe these medicines at that time. Blood samples for research: To study how these cells are working in the patients system, blood samples will be taken each month for six months, at nine months, at one year, 2 years and 3 years following transplant. Approximately 6-8 teaspoons of blood will be collected each time. The total blood drawn for this study over three years should not exceed 1 and 3/4 cups. This amount is considered safe in adults. The amount of blood collected will be decreased in children and/or in patients where this amount of blood collection would not be appropriate.