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).
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,400
Flumatinib 600mg orally daily
Imatinib 400mg orally daily (Reference drug instructions)
Institute of Hematology and Oncology, Harbin The First Hospital
Harbin, Heilongjiang, China
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
Time frame: 12 months
MMR rate of high-risk population treated at the end of 12 months
* High-risk population：Sokal score\>1.2 * MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
Time frame: 12 months
MMR rate at 6, 24 and 36 Months
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
Time frame: 6, 24 and 36 Months
Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months
Cytogenetic response (CyR) is based on the prevalence of Ph+ cells in metaphase from bone marrow (BM) sample. CCyR is defined as 0% Ph+ metaphases in the bone marrow.
Time frame: 6, 12, 24 and 36 Months
Percentage of participants with transformation-free survival (TFS)
TFS was defined as the time between the first dose and the date of transition to AP/BP or the last efficacy assessment during treatment.
Time frame: up to 60 Months
Percentage of participants with progression free survival (PFS)
PFS is defined as the time from the first dose to the date of earliest transition to AP/BC, or the date of death from any cause.
Time frame: up to 60 Months
Percentage of participants with overall survival (OS)
OS was defined as the time between the first dose and the date of death from any cause.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 60 Months
Incidence and severity of adverse events (AE)
Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, and NCI CTCAE v5.0.
Time frame: From baseline until 28 days after the last dose