Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)

Summary

Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.

Timeline

Start

2009-10

Primary completion

2013-06

Completion

2013-06

Publications

• Chevallier P, Labopin M, Socie G, Tabrizi R, Furst S, Lioure B, Guillaume T, Delaunay J, de La Tour RP, Vigouroux S, El-Cheikh J, Blaise D, Michallet M, Bilger K, Milpied N, Moreau P, Mohty M. Results from a clofarabine-busulfan-containing, reduced-toxicity conditioning regimen prior to allogeneic stem cell transplantation: the phase 2 prospective CLORIC trial. Haematologica. 2014 Sep;99(9):1486-91. doi: 10.3324/haematol.2014.108563. Epub 2014 Jun 20.

Drugs

Indications