Trials / Suspended
SuspendedNCT01755325
Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+
Phase III Study of Compound Realgar Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult Patients With Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
- Status
- Suspended
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 680 (estimated)
- Sponsor
- Junmin Li · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Compound realgar natural indigo Tablet | Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd |
| DRUG | placebo |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2012-12-24
- Last updated
- 2018-04-25
Locations
13 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01755325. Inclusion in this directory is not an endorsement.