A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flumatinib, Imatinib.
- Who it may be relevant to
- Registry conditions: CML, Chronic Phase. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
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 treatment of CML-CP in China.
The overall design is a multicenter, prospective, observational study. The study plans to enroll 2,400 newly diagnosed CML-CP subjects.The primary efficacy endpoint is the rate of major molecular response (MMR) , as measured by RQ-PCR at 12 months. Hematologic response, molecular response and cytogenetic response will be assessed at baseline and a certain frequency after treatment, until study completion. (A month is defined as 28 days)
Interventions
- Drug Flumatinib
Flumatinib 600mg orally daily - Drug Imatinib
Imatinib 400mg orally daily (Reference drug instructions)
Primary outcome measures
- Major molecular response (MMR) rate at 12 months [Time frame: 12 months]
Secondary outcome measures (7)
- MMR rate of high-risk population treated at the end of 12 months [Time frame: 12 months]
- MMR rate at 6, 24 and 36 Months [Time frame: 6, 24 and 36 Months]
- Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months [Time frame: 6, 12, 24 and 36 Months]
- Percentage of participants with transformation-free survival (TFS) [Time frame: up to 60 Months]
- Percentage of participants with progression free survival (PFS) [Time frame: up to 60 Months]
- Percentage of participants with overall survival (OS) [Time frame: up to 60 Months]
- Incidence and severity of adverse events (AE) [Time frame: From baseline until 28 days after the last dose]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology and Oncology, Harbin The First Hospital — Harbin
Identifiers
NCT: NCT05367765 · HS-10096-401