drugset / Trial / NCT00008697

Arsenic Trioxide in Treating Patients With Refractory or Recurrent Acute Promyelocytic Leukemia

NCT00008697

RandomizedParallel-groupTreatment

Summary

The purpose of this study is to evaluate both the efficacy and toxicity of infusional arsenic trioxide in the treatment of patients with relapsed or refractory acute promyelocytic leukemia (APML). In addition, correlation between pharmacokinetic data and both therapeutic response and therapy-related toxicities will be sought.

Timeline

Start
1998-11
Primary completion
2002-04
Completion
2002-04

Drugs

EvaluationDrugModalityDoseRoute
Subject arsenic trioxide Small molecule 0.1 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.15 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.2 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.25 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.3 mg/kg Intravenous

Indications