Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
Low-Dose TBI and Fludarabine Followed by Unrelated Donor Stem Cell Transplantation for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial
This clinical trial studies fludarabine phosphate, low-dose total body irradiation, and donor stem cell transplant in treating patients with hematologic malignancies or kidney cancer. Giving chemotherapy drugs, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine before the transplant and cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To determine whether stable allogeneic engraftment from unrelated hematopoietic stem cell
donors can be safely established using a non-myeloablative conditioning regimen in patients
with hematologic malignancies and renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To evaluate whether donor lymphocyte infusion (DLI) can be safely used in patients with
mixed or full donor chimerism to eliminate persistent or progressive disease.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to
-2. Patients also undergo low-dose total-body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) or bone marrow
transplantation on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to
100 with taper to day 177 and mycophenolate mofetil PO BID on days 0-40 with taper to day 96.
Patients with mixed chimerism, persistent or progressive disease, and no evidence of
graft-versus-host disease and who have been off immunosuppression for at least 2 weeks
undergo DLI over 30 minutes. DLI may be repeated every 65 days for up to 3 doses.
After completion of study treatment, patients are follow-up periodically for 5 years.
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