Starting soon
Phase 3
A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
Condition(s) studied
Chronic Myeloid Leukemia
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Inclusion Criteria:
1. Men or women who are ≥ 18 years old at the time of signing the informed consent form
2. The physical condition score (PS) of the Eastern Cooperative Oncology Group (ECOG) in the United States ranges from 0 to 1
3. 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
4. Organ function testing meets protocol requirements and is deemed eligible.
5. 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.
6. Female participants who have a negative blood pregnancy test result or documented evidence of no pregnancy risk.
7. Voluntarily participate in this clinical trial, understand the research procedures, and be able to sign a written informed consent form
Exclusion Criteria:
1. It is known that there is an accelerated or rapidly changing phase of CML
2. It is known that atypical CML (non P210 protein) exists
3. Known presence of central nervous system leukemia or primary chronic myelofibrosis (excluding secondary myelofibrosis grade 1 caused by CML)
4. History of acute or chronic pancreatitis (within 1 year prior to first administration) or long-term alcohol abuse
5. Known to have major congenital or acquired hemorrhagic diseases unrelated to the disease under study
6. Previous participants with malignant tumors other than CML.
7. Impaired cardiac function or cardiac repolarization abnormality.
8. Severe, uncontrolled, or active cardiovascular or cerebrovascular disease.
9. Severe or uncontrolled diabetes mellitus.
10. Severe or uncontrolled hypertension.
11. Serious arteriovenous thrombosis events.
12. History of splenectomy, solid organ or bone marrow/hematopoietic stem cell transplantation, excluding corneal transplantation.
13. Serious infections occurred within 4 weeks prior to the first administration.
14. Clinically significant gastrointestinal dysfunction.
15. Presence of known active infectious disease.
16. Hepatic encephalopathy, hepatorenal syndrome, or ≥ Child Pugh B-grade cirrhosis.
17. History of severe neurological or mental disorders.
18. Have a history of severe allergies or allergic reactions to any components of HS-10382 and TKIs selected by the investigators.
19. Major surgery (craniotomy/thoracotomy/laparotomy) within 12 weeks prior to first dose.
20. Other toxicities from prior antineoplastic therapy with severity of Grade ≥2.
21. Pregnant or lactating female participants, or those planning pregnancy during the study.
22. Any other condition deemed by the investigator to interfere with the participant's ability to participate in the study, not covered above.
Primary outcome measure(s)
- Percentage of Participants With Major Molecular Response (MMR) at Week 48 — At Week 48
Molecular response is assessed using BCR-ABL1 transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
Trial sites (1)
| Facility | City | Region | Status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology |
Wuhan |
China |
|
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