Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.
NCT05311943 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2022-07-29
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.
Conditions
- Olverembatinib
- Chronic Myeloid Leukemia, Chronic Phase
- Tyrosine Kinase Inhibitors
Interventions
- DRUG
-
olverembatinib
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Sponsors & Collaborators
-
Shenzhen Second People's Hospital
lead OTHER
Principal Investigators
-
Xin Du, Phd · Shenzhen Second People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-01
- Primary Completion
- 2024-06-30
- Completion
- 2025-06-30
Countries
- China
Study Locations
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