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A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Summary
This trial is a multicenter, open label, randomized phase III clinical study that evaluates the efficacy of oral HS-10382 versus investigator selected TKIs (imatinib, nilotinib, dasatinib, and flumatinib) in newly diagnosed Ph+CML-CP adult participants. The TKI drug chosen by the investigators is the FDA/NMPA approved CML-CP first-line treatment drug: imatinib or nilotinib or dasatinib or flumatinib.
Official title: A Phase III, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of Oral HS-10382 Compared With Investigator-selected Tyrosine Kinase Inhibitors (TKIs) in Adult Patients With Newly Diagnosed Philadelphia Chromosome-positive Chronic-phase Chronic Myeloid Leukemia.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
408
Start Date
2026-12
Completion Date
2033-06
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
HS-10382
Comes in 40 mg tablets and taken orally
Imatinib
Comes in 100 mg tablets and taken orally
Dasatinib
Comes in 20 mg, 50 mg and 70 mg tablets and taken orally
Nilotinib
Comes in 150 mg capsules and taken orally
Flumatinib
Comes in 0.2 g tablets and taken orally
Locations (1)
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China