Clinical trial NCT05367765: A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: CML, Chronic Phase
Keywords: Chronic Myeloid Leukemia
Flumatinib
BCR-ABL TKI
Real World
Prospective
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-10
Enrollment: 2400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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)

Eligibility criteria: 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 outcomes:
measure: Major molecular response (MMR) rate at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: MMR rate of high-risk population treated at the end of 12 months
timeFrame: 12 months
measure: MMR rate at 6, 24 and 36 Months
timeFrame: 6, 24 and 36 Months
measure: Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months
timeFrame: 6, 12, 24 and 36 Months
measure: Percentage of participants with transformation-free survival (TFS)
timeFrame: up to 60 Months
measure: Percentage of participants with progression free survival (PFS)
timeFrame: up to 60 Months
measure: Percentage of participants with overall survival (OS)
timeFrame: up to 60 Months
measure: Incidence and severity of adverse events (AE)
timeFrame: From baseline until 28 days after the last dose
Other outcomes:
Locations:
city: Harbin
country: China
facility: Institute of Hematology and Oncology, Harbin The First Hospital
state: Heilongjiang
Study officials:
affiliation: Institute of Hematology and Oncology, Harbin The First Hospital
name: Jun Ma
role: PRINCIPAL_INVESTIGATOR
References: