Status:
UNKNOWN
Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
Lead Sponsor:
Shenzhen Second People's Hospital
Conditions:
Olverembatinib
Chronic Myeloid Leukemia, Chronic Phase
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 a...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and ≤75 years.
- Diagnosis of CML-CP.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin \<1.5xULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
- Resistance and/or intolerance of at least two second-generation TKIs.
- 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
- Known to be allergic to study drug ingredients or their analogues.
- History of undergone major surgery within 4 weeks.
- Patients unwilling or unable to comply with the protocol.
- Pregnant or breast-feeding patients.
- patients with other malignant tumor.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05311943
Start Date
July 1 2022
End Date
June 30 2025
Last Update
July 29 2022
Active Locations (1)
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1
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China, 518035