Risk-adapted Therapy for Adult Acute Myeloid Leukemia.
Status:
Completed
Trial end date:
2003-11-01
Target enrollment:
Participant gender:
Summary
In a protocol of treatment of AML used in 1994 for adults with AML up to the age of 50 years,
the Spanish CETLAM group showed a complete remission rate 75 % using the combination of
daunorubicin (60 mg/m2, 3 days) plus conventional dose cytarabine (100mg/m2/day in continuous
infusion during 7 days) and etoposide (100mg/m2 IV/day 3 days). If idarubicin (10 mg/m2, 3
days) was administered instead of daunorubicin, the complete remission (CR) rate in adults up
to 60 years was 75%. To improve the proportion of CRs and to decrease relapse rate appearing
in 50% of patients, the phase II AML-99 trial includes intermediate dose-cytarabine during
induction and risk-adapted post remission treatment based on the improvement in prognostic
characterization of AML and the implementation of novel transplantation techniques.
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias