Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Pilot Trial Of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan, And Low Dose Total Body Irradiation
This clinical trial is studying how well giving fludarabine phosphate and melphalan together with total-body irradiation followed by donor stem cell transplant works in treating patients with hematologic cancer or bone marrow failure disorders. Giving low doses of chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells or abnormal 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 or abnormal cells (graft-versus-tumor effect)
PRIMARY OBJECTIVES:
I. To determine the transplant related mortality (TRM) of this reduced intensity
transplantation (RIT) combination in a patient population that is usually not eligible for a
full myeloablative allogeneic transplant.
SECONDARY OBJECTIVES:
I. To evaluate engraftment, safety, clinical response, evidence of graft-versus-malignancy
effect/graft-versus-host disease (GVHD) and overall outcomes of treatment with our RIT
regimen across a variety of hematological conditions.
OUTLINE: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5
to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body
irradiation on day -1 and allogeneic stem cell transplantation on day 0.
Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis
congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of
melphalan.
After completion of study treatment, patients are followed up periodically.
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