Autologous Hematopoietic Cell Transplantation for Acute Promyelocytic Leukemia After Relapse With Idarubicin and Busulfan Conditioning
Inclusion Criteria:
- Men or women between age 18-60 years old
- Acute promyelocytic leukemia after relapse with confirmed cytogenetics t(15;17) and
molecular analysis (PML-RARalpha)
- Mobilized peripheral CD34+ over 2x106/kg with negative PML-RAR alpha confirmed by
PCR
- European Cooperative Oncology Group performance status 0-3
- Serum bilirubin < 1.5x the upper limit of normal (ULN)
- Serum alanine transaminase (ALT)/aspartate transaminase values < 2.5 x ULN
- Subjects (or their legally acceptable representatives) must signed an informed
consent document indicating that they understanding the purpose of and procedures
required for the study and are willing to participate in the study
Exclusion Criteria:
- Woman of child bearing potential
- Serum creatinine > 400 Micromol/l after initial resuscitation patients with previous
Grade 2-4 peripheral neuropathy
- Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable
dose for at least 3 months before first dose of study drug)
- Uncontrolled or severe cardiovascular disease including myocardial infarction within
6 months of enrollment, uncontrolled angina, clinically significant pericardial
disease, or III-IV heart failure
- Known allergy to idarubicin