Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
Induction of Mixed Hematopoietic Chimerism in Patients Using Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil
This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and donor stem cell transplant followed by cyclosporine, mycophenolate mofetil, and donor lymphocyte infusion in treating patients with hematopoietic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and total body irradiation (TBI) before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also keep the patient's immune response from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To estimate the risk of graft rejection associated with the addition of fludarabine
(fludarabine phosphate) to a non-myeloablative conditioning regimen for patients with
malignant diseases treatable by allogeneic stem cell transplantation and compare this rate to
that observed among patients previously treated without fludarabine.
II. To estimate the rate of grade acute II/IV graft-vs-host disease (GVHD) and chronic GVHD
in patients treated with low-dose total-body irradiation (TBI), fludarabine, peripheral blood
stem cell (PBSC) infusion and immunosuppression with cyclosporine and mycophenolate mofetil.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) on days - 4
to -2 and undergo low-dose TBI on day 0. (Note: Patients who have had an autologous
transplant within 90 days prior to day 0 will not receive fludarabine phosphate.)
PBSC INFUSION: Patients undergo allogeneic PBSC transplant on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine orally (PO) twice daily (BID) on days -3 to
35 with a taper to day 56. Patients receive mycophenolate mofetil PO BID on days 0-27.
POST TRANSPLANT DONOR LYMPHOCYTE INFUSION (DLI): Patients with stable mixed chimerism on day
56, and without evidence of GVHD, undergo DLI IV over 30 minutes on day 65. Patients without
a complete response, full donor chimerism, and GVHD after 2 months undergo further DLI at
higher cell numbers. Up to 6 DLIs may be given 65 days apart.
After completion of study treatment, patients are followed up at 4, 6, 12, 18 and 24 months
and then annually thereafter.
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