A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Evaluating the Efficacy and Safety of Flumatinib Versus Imatinib for in Patients With Newly Diagnosed Chronic Myeloid Leukemia (CML)-in Chronic Phase (CP): A Multicenter, Open-label, Real World Study
1 other identifier
interventional
2,400
1 country
1
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 versus Imatinib as the first line therapy in patients with chronic myleiod leukemia(CML) in chronic phase(CP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 5, 2022
CompletedFirst Posted
Study publicly available on registry
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
May 10, 2022
April 1, 2022
5 years
May 5, 2022
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major molecular response (MMR) rate at 12 months
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
12 months
Secondary Outcomes (7)
MMR rate of high-risk population treated at the end of 12 months
12 months
MMR rate at 6, 24 and 36 Months
6, 24 and 36 Months
Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months
6, 12, 24 and 36 Months
Percentage of participants with transformation-free survival (TFS)
up to 60 Months
Percentage of participants with progression free survival (PFS)
up to 60 Months
- +2 more secondary outcomes
Study Arms (2)
Flumatinib mesylate tablets
EXPERIMENTALImatinib mesylate tablets
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology and Oncology, Harbin The First Hospital
Harbin, Heilongjiang, 201203, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Ma
Institute of Hematology and Oncology, Harbin The First Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2022
First Posted
May 10, 2022
Study Start
April 30, 2022
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
May 10, 2022
Record last verified: 2022-04