A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia
Current reduced intensity conditioning regimens have been able to decrease TRM (treatment
related mortality) but suffer from increased rates of disease relapse. Disease burden at
transplantation, as measured by percent myeloblasts, predicts relapse. Current regimens
employ fludarabine and busulfan with various adjutants, but these agents are not part of the
usual armamentarium used versus leukemia and have questionable anti-leukemic activity. By
substituting clofarabine and cytarabine, a combination with proven anti-leukemic activity in
the relapsed and refractory setting as well as activity versus MDS, as the back bone of the
regimen we hope overcome residual disease and improve post-transplant relapse rates.
Furthermore the principal toxicity of this regimen is myelosuppression, which should be
abrogated by the infusion of stem cells. Thymoglobulin is included due to its minimal
contribution to toxicity but significant benefits in engraftment, and controlling acute and
chronic GVHD, which are major contributors to TRM and disease specific activity in MDS.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the six-month treatment related mortality for a conditioning regimen composed of clofarabine, cytarabine, and thymoglobulin for allogeneic transplantation of myelodysplastic syndromes and acute myeloid leukemia.
Ravi Vij, M.D.
Washington Universtiy of St. Louis
United States: Institutional Review Board
|Ravi Vij, M.D.||St. Louis, Missouri 63110|