Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial
This phase I/II trial studies whether a new kind of blood stem cell (bone marrow) transplant, that may be less toxic, is able to treat underlying blood cancer. Stem cells are "seed cells" necessary to make blood cells. Researchers want to see if using less radiation and less chemotherapy with new immune suppressing drugs will enable a stem cell transplant to work. Researchers are hoping to see a mixture of recipient and donor stem cells after transplant. This mixture of donor and recipient stem cells is called "mixed-chimerism". Researchers hope to see these donor cells eliminate tumor cells. This is called a "graft-versus-leukemia" response.
PRIMARY OBJECTIVES:
I. To determine whether stable unrelated peripheral blood stem cell (PBSC) grafts can be
safely established using nonmyeloablative pretransplant conditioning with intensified
post-grafting immunosuppression and with every (q) 8 hours (hr) and possibly q 6 hr
mycophenolate mofetil (MMF) dosing in patients with hematologic malignancies and renal cell
carcinoma.
II. To determine if the incidence and severity of acute grades II-IV graft-versus-host
disease (GVHD) can be reduced in patients with sustained engraftment with the use of q 8 hr
MMF dosing.
SECONDARY OBJECTIVES:
I. To determine if engraftment can be maintained in patients with low chimerism and high risk
of rejection with the use of a single dose of fludarabine (fludarabine phosphate) followed by
donor lymphocyte infusion (DLI) on continued MMF/cyclosporine (CSP).
II. To compare survival and disease free survival to those achieved under protocol 1463.
OUTLINE:
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) on
days -4, -3, and -2 and undergo total-body irradiation (TBI) on day 0.
TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) 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 every 8 hours on days 0-40 with taper
to day 96.
After completion of study treatment, patients are followed up at 6 months, 1 year, 1.5 years,
2 years, and then annually thereafter.
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