Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Prolonged Mycophenolate Mofetil and Truncated Cyclosporine Postgrafting Immunosuppression to Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-Center Trial
This phase I/II trial studies whether stopping cyclosporine before mycophenolate mofetil is better at reducing the risk of life-threatening graft-versus-host disease (GVHD) than the previous approach where mycophenolate mofetil was stopped before cyclosporine. The other reason this study is being done because at the present time there are no curative therapies known outside of stem cell transplantation for these types of cancer. Because of age or underlying health status, patients may have a higher likelihood of experiencing harm from a conventional blood stem cell transplant. This study tests whether this new blood stem cell transplant method can be made safer by changing the order and length of time that immune suppressing drugs are given after transplant.
PRIMARY OBJECTIVES:
I. To determine whether the incidence of life-threatening GVHD can be reduced after unrelated
donor peripheral blood mononuclear cell (PBMC) hematopoietic cell transplantation (HCT) using
nonmyeloablative conditioning with earlier discontinuation of cyclosporine (CSP) and extended
administration of mycophenolate mofetil (MMF) in patients with hematologic malignancies and
metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To compare the incidence of acute and chronic GVHD to protocols 1463 and 1641.
II. To compare the utilization of corticosteroids to protocols 1463 and 1641.
III. To compare survival to that achieved under protocol 1463 and 1641.
OUTLINE:
CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on
days -4 to -2, and undergo total-body irradiation (TBI) on day 0.
TRANSPLANTATION: Patients undergo allogeneic PBMC transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to
80 with taper to day 150 and mycophenolate mofetil PO or IV thrice daily (TID) on days 0-30,
BID on days 31-150, and then taper to day 180. Treatment continues in the absence of
unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for 24 months and
then yearly for 5 years.
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