Status:
NOT_YET_RECRUITING
A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
CML, Chronic Phase
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Flumatinib is an orally available TKI with high selectivity and potency against BCR-ABL1 kinase. It's a multi-center, open-label, real world study to explore the efficacy and safety of Flumatinib vers...
Detailed Description
The purpose of this study is to investigate the long-term efficacy and safety of Flumatinib versus Imatinib in newly diagnosed CML-CP patients to the provide the real world evidence for the clinical t...
Eligibility Criteria
Inclusion
- Men or women aged more than or equal to (≥) 18 years.
- Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
- Eastern Cooperative Oncology Group (ECOG) performance status: 0\~2.
- Signed and dated Informed Consent Form.
Exclusion
- Patients with previously documented T315I mutation.
- Received BCR-ABL TKI(s) treatment before enrollment.
- Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
- Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
- Pregnant or lactating female.
Key Trial Info
Start Date :
April 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT05367765
Start Date
April 30 2022
End Date
April 30 2028
Last Update
May 10 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Hematology and Oncology, Harbin The First Hospital
Harbin, Heilongjiang, China, 201203