A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Hansoh Pharma

Status and phase: Not yet enrolling; Phase 4

Conditions: CML, Chronic Phase

Treatments: Drug: Flumatinib; Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05367765

HS-10096-401

Details and patient eligibility

About

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).

Full 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)

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

Flumatinib mesylate tablets

Experimental group

Treatment:

Drug: Flumatinib

Imatinib mesylate tablets

Active Comparator group

Treatment:

Drug: Imatinib