Status:
UNKNOWN
Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure
Lead Sponsor:
Shenzhen Second People's Hospital
Collaborating Sponsors:
Hainan General Hospital
Sanya Central Hospital
Conditions:
Flumatinib
Chronic Myeloid Leukemia, Chronic Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.
Detailed Description
A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ i...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Diagnosis of CML-CP with Ph+.
- ECOG performance of 0-2.
- Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
- Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%.
- 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
- Previously documented T315I mutation.
- History of TKI treatments except of imatinib.
- 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 :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04677439
Start Date
January 1 2021
End Date
December 30 2023
Last Update
March 16 2022
Active Locations (1)
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1
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China, 518035