drugset / Trial / NCT01716793

Risk-adapted Therapy for Adult Acute Myeloid Leukemia.

NCT01716793 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
1998-09
Primary completion
1998-09
Completion
2003-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 500 mg/m2 Intravenous
Subject Cytarabine Small molecule 3000 mg/m2 Intravenous