A Phase 3 interventional study of HS-10382 and Imatinib in Chronic Myeloid Leukemia, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. (part of Hansoh Pharmaceutical Group Company Limited) · Phase 3, Interventional, and Treatment
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.
This study is a phase III, multi-center, open-label, randomized study of oral HS-10382 160 mg BID versus Investigator selected TKI (imatinib, nilotinib, dasatinib, or flumatinib) in adult patients with newly diagnosed Ph+ CML-CP.
Approximately 408 patients will be randomized in a 1:1 ratio to HS-10382 and Investigator selected TKI to join the treatment period.
Randomization will be stratified based on the following two stratification factors:
ELTS score (low versus intermediate versus high)
Pre-randomization selected TKI (imatinib versus 2G TKI (nilotinib or dasatinib or flumatinib)).
Prior to randomization, the Investigator, in consultation with the patient, considering the current treatment paradigm and patient characteristics and comorbidities, will make a selection of preference for imatinib or 2G TKI (nilotinib or dasatinib or flumatinib) if the patient is randomized to the comparator arm. The stratified randomization based on these two stratification factors will help to achieve a balance across the treatment arms for the possible comorbidities and baseline characteristics of patients enrolled in the study.
To further ensure that the distribution of patients, between imatinib and 2G TKIs (nilotinib or dasatinib or flumatinib), in the Investigator selected TKI arm is reflective of the use of these agents in clinical practice, the enrollment into the strata of imatinib versus 2G TKI (nilotinib or dasatinib or flumatinib) based on the pre-randomization selection of TKI will be managed by Interactive Response Technology to be approximately 50% versus 50%.
Duration of Study treatment: Patients on the study will continue to receive the assigned treatment until the End of Study, premature discontinuation due to treatment failure, disease progression or intolerance, due to Investigator or participant decision.
982 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.
This study's planned enrollment of 408 is above the median of 43 across 755 interventional studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 135 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
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
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
Comes in 40 mg tablets and taken orally
Comes in 100 mg tablets and taken orally
Comes in 20 mg, 50 mg and 70 mg tablets and taken orally
Comes in 150 mg capsules and taken orally
Comes in 0.2 g tablets and taken orally
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).
Time frame: At Week 48
Major Molecular Response at Week 96
Molecular response is assessed using BCR-ABL 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).
Time frame: At Week 96
Major Molecular Response at Scheduled Data Collection Time Points
Molecular response is assessed using BCR-ABL 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).
Time frame: Planned total follow-up duration of 5 years
Time to Discontinuation of Study Treatment Due to Adverse Events (TTDAE)
TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to Adverse Event (AE). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date.
Time frame: Planned total follow-up duration of 5 years
Change From Baseline in EORTC QLQ-C30 Scales
The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) assesses the quality of life of cancer patients. It consists of functioning scales, symptom scales, and the global health status quality of life (QoL) scale. A high score for functional and QoL items/scales from the QLQ-30 represents better function and QOL. A high score in symptoms items from QLQ-30 represents worse symptoms.
Time frame: Planned total follow-up duration of 5 years
Change From Baseline in EORTC QLQ-CML24 Scales
The QLQ-CML24 consists of multi-scale items: symptom burden, impact on worry/mood, impact on daily life, body image problems, satisfaction with care and information and satisfaction with social life. A higher score on most of the item scales in QLQ-CML24 reflects a larger impairment in the corresponding domain, with the exception of the satisfaction with care and information, and problems and satisfaction with social life, where a higher score reflects a higher level of satisfaction.
Time frame: Planned total follow-up duration of 5 years
Start is estimated for Dec 2026; primary completion for Jul 2029, 31 months later.
Of 26 phase 3 interventional studies under Leukemia, Myelogenous, Chronic, BCR-ABL Positive, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 79. This study's planned 31 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Embibatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive →
Jiangsu Hansoh Pharmaceutical Co., Ltd. →