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

NCT07885293 | Not Yet Recruiting Phase 3

• 1 other identifier: HS-10382-301
• Study Type: interventional
• Target: 408
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Myeloid Leukemia

Keywords

Chronic Myeloid Leukemia (CML); BCR-ABL allosteric kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Major Molecular Response (MMR) 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).

  At Week 48

Secondary Outcomes (5)

• Major Molecular Response at Week 96

  At Week 96

• Major Molecular Response at Scheduled Data Collection Time Points

  Planned total follow-up duration of 5 years

• Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE)

  Planned total follow-up duration of 5 years

• Change From Baseline in EORTC QLQ-C30 Scales

  Planned total follow-up duration of 5 years

• Change From Baseline in EORTC QLQ-CML24 Scales

  Planned total follow-up duration of 5 years

Study Arms (2)

HS-10382

EXPERIMENTAL

Patients will take HS-10382 160mg BID under fasting conditions on ongoing basis; Patients will be randomized 1:1 versus Investigator selected TKIs

Drug: HS-10382

Investigator selected TKIs

ACTIVE COMPARATOR

Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Dasatinib 100 mg QD administered with or without a meal Nilotinib 300 mg BID administered under fasting conditions Flumatinib 600 mg QD administered under fasting conditions

Drug: Imatinib; Drug: Dasatinib; Drug: Nilotinib; Drug: Flumatinib

Interventions

HS-10382 DRUG

Comes in 40 mg tablets and taken orally

HS-10382

Imatinib DRUG

Comes in 100 mg tablets and taken orally

Investigator selected TKIs

Dasatinib DRUG

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

Investigator selected TKIs

Nilotinib DRUG

Comes in 150 mg capsules and taken orally

Investigator selected TKIs

Flumatinib DRUG

Comes in 0.2 g tablets and taken orally

Investigator selected TKIs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• History of acute or chronic pancreatitis (within 1 year prior to first administration) or long-term alcohol abuse
• Known to have major congenital or acquired hemorrhagic diseases unrelated to the disease under study
• Previous participants with malignant tumors other than CML.
• 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.
• Serious infections occurred within 4 weeks prior to the first administration.
• Clinically significant gastrointestinal dysfunction.
• Presence of known active infectious disease.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430048, China

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate; Dasatinib; nilotinib; flumatinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Thiazoles; Sulfur Compounds; Azoles

Central Study Contacts

Yu Hu, Ph.D

CONTACT

+86 13986183871; dr_huyu@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): June 1, 2033
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

CN (1)