Risk Adapted Treatment for Primary AML in Adults up to the Age of 60 Years.
Induction chemotherapy: idarubicin (12mg/m2/day intravenous), intermediate-dose cytarabine
(500mg/m2/12h, intravenous) and etoposide (100mg/m2/day, intravenous) in 3+7+3 schedule.
This induction therapy is repeated if complete remission (CR) is not achieved after the
first course of treatment.
Consolidation therapy: mitoxantrone (12mg/m2/day, intravenous, days 4, 5 and 6) and
intermediate-dose cytarabine (500mg/m2/12h from day 1 to 6).
Risk-stratification according to cytogenetics, courses to CR and availability of an
- Patients in the favorable cytogenetics group [t(8;21), inv(16) or t(16;16)] are treated
with high-dose cytarabine (3g/m2/12h, intravenous, days 1, 3 and 5).
- Patients in intermediate cytogenetics group (normal karyotype and a single course to
achieve the CR) receive an autologous peripheral blood stem cell (PBSC) transplant,
regardless of having an HLA-identical sibling.
- The remaining patients are considered in the high-risk group and are treated with
autologous or allogeneic PBSC transplantation depending on the availability of a
sibling donor. In allotransplants, CD34+ cell selection of hematopoietic cells is
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate.
Analyze the efficacy and toxicity of IDICE (idarubicin, intermediate doses of ara-C and etoposide) to achieve complete remission.
Jorge Sierra, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spain: Comité Ético de Investigación Clínica