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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-30

Study Completion Date

2028-04-30

Brief Summary

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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).

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Detailed Description

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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)

Conditions

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CML, Chronic Phase

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Flumatinib mesylate tablets

Group Type EXPERIMENTAL

Flumatinib

Intervention Type DRUG

Flumatinib 600mg orally daily

Imatinib mesylate tablets

Group Type ACTIVE_COMPARATOR

Imatinib

Intervention Type DRUG

Imatinib 400mg orally daily (Reference drug instructions)

Interventions

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Flumatinib

Flumatinib 600mg orally daily

Intervention Type DRUG

Imatinib

Imatinib 400mg orally daily (Reference drug instructions)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No