Tests HS-10382 against standard drugs in adults newly diagnosed with chronic myeloid leukemia
Compares HS-10382 with imatinib, nilotinib, dasatinib or flumatinib in newly diagnosed chronic myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 3
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07885293
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Men or women who are ≥ 18 years old at the time of signing the informed consent form; The physical condition score (PS) of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1; First diagnosis of Ph+CML-CP within the first 3 months of randomization: positive for Ph chromosome t (9; 22) in bone marrow cytogenetics and/or positive for BCR/ABL fusion gene in molecular biology testing; Organ function testing meets protocol requirements and is deemed eligible; Female participants of childbearing age are willing to take appropriate contraceptive measures and should not breastfeed from the time of signing informed consent until 6 months after the last use of the study treatment; Male participants were willing to use barrier contraception (i.e. condoms) from the time of signing informed consent until 6 months after the last use of the study treatment. The TKI participants selected by the researchers can follow the contraceptive requirements in the TKI instructions; Female participants who have a negative blood pregnancy test result or documented evidence of no pregnancy risk; Voluntarily participate in this clinical trial, understand the research procedures, and be able to sign a written informed consent form.
Exclusion: History of acute or chronic pancreatitis (within 1 year prior to first administration) or long-term alcohol abuse; Previous participants with malignant tumors other than CML; Serious infections occurred within 4 weeks prior to the first administration; Major surgery (craniotomy/thoracotomy/laparotomy) within 12 weeks prior to first dose; Other toxicities from prior antineoplastic therapy with severity of Grade ≥2; Known to have major congenital or acquired hemorrhagic diseases unrelated to the disease under study; Impaired cardiac function or cardiac repolarization abnormality; Severe, uncontrolled, or active cardiovascular or cerebrovascular disease; Severe or uncontrolled diabetes mellitus; Severe or uncontrolled hypertension; Serious arteriovenous thrombosis events; History of splenectomy, solid organ or bone marrow/hematopoietic stem cell transplantation, excluding corneal transplantation; Presence of known active infectious disease; Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis; History of severe neurological or mental disorders; Have a history of severe allergies or allergic reactions to any components of HS-10382 and TKIs selected by the investigators; Any other condition deemed by the investigator to interfere with the participant's ability to participate in the study, not covered above; It is known that there is an accelerated or rapidly changing phase of CML; It is known that atypical CML (non P210 protein) exists; Known presence of central nervous system leukemia or primary chronic myelofibrosis (excluding secondary myelofibrosis grade 1 caused by CML); Clinically significant gastrointestinal dysfunction; Pregnant or lactating female participants, or those planning pregnancy during the study.