Allo-SCT conditioning for myelodysplastic syndrome and acute myeloid leukemia with clofarabine, cytarabine and ATG

Bone Marrow Transplant. 2009 Jul;44(1):13-7. doi: 10.1038/bmt.2008.423. Epub 2009 Jan 12.

Abstract

The application of myeloablative Allo-SCT is limited by its associated morbidity and mortality. Reduced-intensity conditioning regimens attempt to diminish these, but are associated with a higher risk of disease relapse. Given the evidence of activity of clofarabine and cytarabine in myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), we explored a novel reduced-intensity conditioning regimen based on this backbone. Patients received clofarabine 40 mg/m(2) i.v. on days -6 to -2, cytarabine 1 g/m(2) i.v. on days -6 to -2 and anti-thymocyte globulin (ATG) 1 mg/kg on day -4 and 2.5 mg/kg x 2 days on days -3 and -2. Seven patients were enrolled. Their median age was 54 years; three were with MDS and four with AML. The median duration of neutropenia was 14 days and that of thrombocytopenia was 22 days. Toxicities included hand-foot syndrome (57% grade 2), elevated alanine aminotransferase (ALT) (57% grade 3), elevated aspartate aminotransferase (AST) (86% grade 3) and hyperbilirubinemia (29% grade 3-5). No acute GVHD was observed. Enrollment to the trial was halted after three of the first seven patients expired on days +15, +26 and +32. Three of the four surviving patients have relapsed with a median TTP of 152 days. This regimen was not sufficiently immunosuppressive to ensure engraftment, and was associated with substantial morbidity and mortality.

Publication types

  • Clinical Trial

MeSH terms

  • Adenine Nucleotides / administration & dosage*
  • Adenine Nucleotides / adverse effects
  • Adult
  • Aged
  • Antilymphocyte Serum / administration & dosage*
  • Antilymphocyte Serum / adverse effects
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Arabinonucleosides / administration & dosage*
  • Arabinonucleosides / adverse effects
  • Clofarabine
  • Cytarabine / administration & dosage*
  • Cytarabine / adverse effects
  • Disease-Free Survival
  • Female
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Leukemia, Myeloid, Acute / mortality
  • Leukemia, Myeloid, Acute / therapy*
  • Male
  • Middle Aged
  • Myelodysplastic Syndromes / mortality
  • Myelodysplastic Syndromes / therapy*
  • Stem Cell Transplantation*
  • Survival Rate
  • Time Factors
  • Transplantation Conditioning / methods*
  • Transplantation, Homologous

Substances

  • Adenine Nucleotides
  • Antilymphocyte Serum
  • Antimetabolites, Antineoplastic
  • Arabinonucleosides
  • Immunosuppressive Agents
  • Cytarabine
  • Clofarabine