drugset / Trial / NCT00513305

Cytarabine in Combination With Arsenic Trioxide vs. Cytarabine Alone in Elderly Patients With Acute Myeloid Leukemia

NCT00513305

Phase 3 Terminated 67 enrolled Cephalon
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to determine whether low-dose cytarabine in combination with arsenic trioxide is more effective than low-dose cytarabine alone in achieving complete remission in elderly patients (≥60 years of age) with acute myeloid leukemia.

Timeline

Start
2007-10
Primary completion
2009-07
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cytarabine Small molecule 10 mg/m2 Subcutaneous
Comparator arsenic trioxide Small molecule 0.25 mg/kg Intravenous