Imatinib: Imatinib 400mg orally daily (Reference drug instructions)
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Men or women aged more than or equal to (≥) 18 years.
2. Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
3. Eastern Cooperative Oncology Group (ECOG) performance status: 0\~2.
4. Signed and dated Informed Consent Form.
Exclusion Criteria:
1. Patients with previously documented T315I mutation.
2. Received BCR-ABL TKI(s) treatment before enrollment.
3. Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
4. Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
5. Pregnant or lactating female.
Primary outcome measure(s)
Major molecular response (MMR) rate at 12 months — 12 months MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Oncology, Harbin The First Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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