Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Nonmyeloablative PBSC Allografting From HLA Matched Related Donors Using Fludarabine and/or Low Dose TBI With Disease-Risk Based Immunosuppression
This clinical trial studies fludarabine phosphate and total-body radiation followed by donor peripheral blood stem cell transplant and immunosuppression in treating patients with hematologic malignancies. Giving chemotherapy 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. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine phosphate, cyclosporine, and mycophenolate mofetil before transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To estimate the rate of grade III/IV graft-versus-host disease (GVHD) in patients treated
with low-dose total body irradiation (TBI), fludarabine (fludarabine phosphate), PBSC
infusion and immunosuppression with mycophenolate mofetil and a disease risk-based
cyclosporine taper.
II. To estimate the risk of graft rejection, GVHD, disease response, non-relapse mortality
and the incidence and severity of infectious complications using this treatment strategy.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
ARM I (indolent disease):
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days -4 to
-2 and undergo TBI on day 0.
TRANSPLANTATION: Patients undergo donor peripheral blood stem cell transplantation (PBSCT) on
day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) or IV every
8-12 hours on days -3 to 56 with a taper to day 180 and mycophenolate mofetil PO BID or IV
every 8-12 hours on days 0 to 27.
ARM II (aggressive disease):
CONDITIONING REGIMEN: Patients receive fludarabine phosphate and undergo TBI as in Arm I.
TRANSPLANTATION: Patients undergo donor PBSCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID or IV every 8-12 hours on days -3 to
56 with a taper to day 70 and mycophenolate mofetil as in Arm I.
After completion of study treatment, patients are followed up for 5 years.
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