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+
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Compound Realgar Formula Realgar-Indigo Naturalis | Unknown | 65 mg/kg | — |
| Background | Imatinib | Small molecule | 0.4 g | — |