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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
680
Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks. imatinib,0.4g,qd
Union Hospital medical college Huazhong University of Science and Technology
Wuhan, Hubei, China
The NO.1 People's Hospital of Huaian
Huaian, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
To compare the rate of Major molecular response(MMR) at 12 months
Time frame: 12 months of follow-up from the start of treatment
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Nanjing, Jiangsu, China
First Hospital Affiliated to Suzhou University
Suzhou, Jiangsu, China
The FIrst Affiliated Hospital, College of Medicine, Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital, College of Medicine, Nanchang University
Nanchang, Jiangxi, China
The Tumor Hospital of Jiangxi
Nanchang, Jiangxi, China
The NO.1 Hospital of Nanchang
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Xijing Hospital-Fourth Military Medical University
Xi'an, Shan'xi, China
...and 3 more locations