Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the 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 cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening
PRIMARY OBJECTIVES:
I. To determine the transplant related mortality (TRM) of this reduced-intensity
transplantation (RIT) combination, fludarabine (fludarabine phosphate), melphalan, and TBI in
a patient population usually not eligible for a full a myeloablative allogeneic hematopoietic
stem cell transplantation (HSCT).
SECONDARY OBJECTIVES:
I. To evaluate clinical response, progression free survival (PFS) at one year, engraftment
rate, and graft-versus-host disease (GvHD) incidence with the proposed RIT regimen across a
variety of hematological conditions.
II. Correlative studies will include chimerism analysis by molecular analysis and evaluation
of immune reconstitution by cytomegalovirus (CMV) dextramer analysis using flow cytometry.
OUTLINE: PREPARATIVE REGIMEN:
Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2
and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI twice daily (BID)
on day -1.
TRANSPLANTATION:
Patients undergo allogeneic PBSCT on day 0.
GvHD PROPHYLAXIS:
Patients receive tacrolimus IV or orally (PO) BID on days -1 to 100 with taper over 4-6
months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15-30 minutes
on days 1, 3, and 6. After completion of study treatment, patients are followed up
periodically.
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