drugset / Trial / NCT01755325

Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+

NCT01755325

Phase 3 Suspended 680 enrolled Junmin Li
RandomizedParallel-groupQuadruple-blindTreatment

Summary

It is an open-label, randomized, double blind, placebo-controlled parallel-group, multi-center study to evaluate the efficacy and safety of Compound realgar formula Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia in the chronic phase (CML-CP).

Timeline

Start
2012-11
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Compound Realgar Formula Realgar-Indigo Naturalis Unknown 65 mg/kg
Background Imatinib Small molecule 0.4 g