Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07885293
PHASE3

A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

HS-10382

Comes in 40 mg tablets and taken orally

DRUG

Imatinib

Comes in 100 mg tablets and taken orally

DRUG

Dasatinib

Comes in 20 mg, 50 mg and 70 mg tablets and taken orally

DRUG

Nilotinib

Comes in 150 mg capsules and taken orally

DRUG

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