Clinical Trials List
Protocol NumberHQP1351CG301
NCT Number(ClinicalTrials.gov Identfier)NCT06423911
Not yet recruiting
2025-04-18 - 2029-04-22
Phase III
Recruiting2
This is a Global, Multi-center, Open-label Randomized and Registrational Phase 3 Study of Olverembatinib (HQP1351) in Patients With Chronic Phase Chronic Myeloid Leukemia
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/06/12
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsai-Yun Chen
Co-Principal Investigator
- Sin-Syue Li Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
- 張力常 Division of General Internal Medicine
- Ya-Ping Chen Division of Hematology & Oncology
- 傅蓓安 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Myeloid Leukemia
Objectives
The purpose of Part A of this trial is to answer the following research questions:
1. What are the long-term response rates of olverembatinib compared to bosutinib at 24 and 96 weeks?
2. What are the other parameters of maximum efficacy of olverembatinib compared to bosutinib?
3. What is the safety profile of olverembatinib compared to bosutinib?
4. What changes in the BCR::ABL1 gene are unresponsive to treatment?
5. How does the BCR::ABL1 gene respond to olverembatinib?
6. How effective is olverembatinib compared to bosutinib?
The purpose of Part B of this trial is to answer the following questions:
1. What are the long-term response rates of olverembatinib at 24 and 96 weeks in patients with CML-CP harboring the T315I mutation?
2. What are the other parameters for maximizing the efficacy of Olverembatinib in CML-CP patients with the T315I mutation?
3. What is the safety profile of Olverembatinib in CML-CP patients with the T315I mutation?
4. What changes in the BCR::ABL1 gene are unresponsive to treatment?
5. How does the BCR::ABL1 gene respond to Olverembatinib?
6. How effective is Olverembatinib?
Test Drug
Tablets
Active Ingredient
Olverembatinib
Dosage Form
110
Dosage
10 mg/tablet
Endpoints
Part A: Randomized Controlled Group
Primary Objective
• Compare the primary molecular response (MMR) rate of olverembatinib compared to bosutinib at 24 weeks.
Part B: Single-Arm Group
Primary Objective
• Evaluate the MMR rate of olverembatinib at 24 weeks in patients with CML-CP harboring the T315I mutation.
Primary Objective
• Compare the primary molecular response (MMR) rate of olverembatinib compared to bosutinib at 24 weeks.
Part B: Single-Arm Group
Primary Objective
• Evaluate the MMR rate of olverembatinib at 24 weeks in patients with CML-CP harboring the T315I mutation.
Inclution Criteria
Inclusion Criteria:
Patients eligible for inclusion in this study must meet all of the following criteria.
Age ≥ 18 years old.
Diagnosis of CML-CP
Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Written informed consent obtained prior to any screening procedures.
Patients with adequate organ functions
Patients eligible for inclusion in this study must meet all of the following criteria.
Age ≥ 18 years old.
Diagnosis of CML-CP
Part A: Previously treated with at least two approved TKIs Part B: T315I mutation at screening.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Written informed consent obtained prior to any screening procedures.
Patients with adequate organ functions
Exclusion Criteria
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria.
For Part A only: T315I mutation at any time prior to starting study treatment.
Active infection that requires systemic drug therapy
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
Pregnant or nursing (lactating) women.
Patients eligible for this study must not meet any of the following criteria.
For Part A only: T315I mutation at any time prior to starting study treatment.
Active infection that requires systemic drug therapy
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs
Previous treatment with or known / suspected hypersensitivity to olverembatinib or any of its excipients.
Previous treatment with or known / suspected hypersensitivity to bosutinib or any of its excipients.
Pregnant or nursing (lactating) women.
The Estimated Number of Participants
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Taiwan
6 participants
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Global
333 participants
