Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
Study Details
Study Description
Brief Summary
The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: olverembatinib 40mg, taken orally once every other day of a 28-day cycle |
Drug: olverembatinib
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test. [12 months]
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Secondary Outcome Measures
- The proportion of patients with MMR at 3, 6, 9 months. [3, 6, 9 months.]
- The proportion of patients with MR 4.0 at 3, 6, 9, 12 months. [3, 6, 9, 12 months.]
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
- Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. [3, 6, 9, 12 months.]
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
- Progression free survival (PFS) [12 months]
PFS is defined as the interval between the first dose date and the first date at which the criteria for progression are met, or death.
- Overall survive (OS) [12 months]
OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.
- Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib. [12 months.]
Evaluation of adverse events (AEs), serious AEs (SAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years and ≤75 years.
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Diagnosis of CML-CP.
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ECOG performance of 0-2.
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Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT <2.5x ULN, creatinine <1.5x ULN.
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Resistance and/or intolerance of at least two second-generation TKIs.
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Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Exclusion Criteria:
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Known to be allergic to study drug ingredients or their analogues.
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History of undergone major surgery within 4 weeks.
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Patients unwilling or unable to comply with the protocol.
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Pregnant or breast-feeding patients.
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patients with other malignant tumor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shenzhen Second People's Hospital | Shenzhen | Guangdong | China | 518035 |
Sponsors and Collaborators
- Shenzhen Second People's Hospital
Investigators
- Study Chair: Xin Du, Phd, Shenzhen Second People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OLV20220331