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

NCT01755325 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2018-04-25

No results posted yet for this study

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

  • Chronic Myelogenous Leukemia

Interventions

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

Sponsors & Collaborators

  • Junmin Li

    lead OTHER

Principal Investigators

  • Saijuan Chen, M.D. · Runjin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755325 on ClinicalTrials.gov