drugset / Trial / NCT00480064

Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

NCT00480064

Phase 3 Completed 360 enrolled French Innovative Leukemia Organisation
RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

Timeline

Start
1995-07
Primary completion
Completion
2007-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Subcutaneous
Subject Lomustine Small molecule 200 mg/m2