Risk Adapted Treatment for Primary AML in Adults, Based on Genetics and Minimal Residual Disease (MRD) in Patients up to the Age of 70 Years.
Induction chemotherapy: idarubicin (12mg/m2/day intravenous, days 1, 3 and 5),
intermediate-dose cytarabine (500mg/m2/12h, intravenous, days 1, 3 and 5) and etoposide
(100mg/m2/day, intravenous, from day 1 to 3) as in AML-99 trial (NCT01716793), with the
addition of subcutaneous G-CSF from day 0 to the last day of chemotherapy. This induction
therapy is repeated if complete remission (CR) is not achieved after the first course of
Consolidation therapy (as in AML-99 trial): mitoxantrone (12mg/m2/day, intravenous, days 4
to 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)] and
Leukocyte index <20 at diagnosis (LI=white blood cell count (WBC) x (blasts in bone
marrow/100) are treated with one course of high-dose cytarabine (3g/m2/12h,
intravenous, days 1, 3 and 5), but in case of LI>20 at diagnosis the intention is to
perform an autologous peripheral blood stem cell (PBSC) transplantation.
- Patients in intermediate risk group, with normal karyotype, a single course of
induction chemotherapy to achieve the CR, the absence of adverse molecular features
(FLT3-ITD or MLL-PTD) and low minimal residual disease levels after consolidation
(MRD<0,1%) receive an autologous PBSC transplant, regardless of having an HLA-identical
- The remaining patients defined as high-risk patients are treated with an allogeneic
stem cell transplantation. Depending on the age, if the patient has an HLA-identical
sibling donor, up to age of 50 years old it is performed with conventional conditioning
therapy and positive selection of CD34+, older patients receive a reduced intensity
- Very high risk patients without a sibling are allocated to unrelated donor (9-10/10).
Patients with adverse cytogenetics and/or FLT3-ITD without an adequate donor received
Mylotarg™ as "in vivo purging" followed by an autologous PBSC transplantation.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete remission rate (CRR)
Analyze the efficacy and toxicity of IDICE-G (idarubicin, intermediate doses of ara-C and etoposide) and G-CSF to achieve complete remission.
Jorge Sierra, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spain: Departament de Salut de la Generalitat de Catalunya