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

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05367765

Collaborator

(none)

2,400

Enrollment

Location

Arms

Anticipated Duration (Months)

33.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
CML, Chronic Phase	Drug: Flumatinib Drug: Imatinib	Phase 4

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)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 30, 2022

Anticipated Primary Completion Date :

Apr 30, 2027

Anticipated Study Completion Date :

Apr 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flumatinib mesylate tablets	Drug: Flumatinib Flumatinib 600mg orally daily
Active Comparator: Imatinib mesylate tablets	Drug: Imatinib Imatinib 400mg orally daily (Reference drug instructions)

Arm

Intervention/Treatment

Experimental: Flumatinib mesylate tablets

Drug: Flumatinib

Flumatinib 600mg orally daily

Active Comparator: Imatinib mesylate tablets

Drug: Imatinib

Imatinib 400mg orally daily (Reference drug instructions)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

MMR rate of high-risk population treated at the end of 12 months [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.
MMR rate at 6, 24 and 36 Months [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.
Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months [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.
Percentage of participants with transformation-free survival (TFS) [up to 60 Months]
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.
Percentage of participants with progression free survival (PFS) [up to 60 Months]
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.
Percentage of participants with overall survival (OS) [up to 60 Months]
OS was defined as the time between the first dose and the date of death from any cause.
Incidence and severity of adverse events (AE) [From baseline until 28 days after the last dose]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women aged more than or equal to (≥) 18 years.
Patients with Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis..
Eastern Cooperative Oncology Group (ECOG) performance status: 0~2.
Signed and dated Informed Consent Form.

Exclusion Criteria:

Patients with previously documented T315I mutation.
Received BCR-ABL TKI(s) treatment before enrollment.
Any treatment with anti-CML therapy over 2 weeks or hematopoietic stem cell transplantation before enrollment
Participated in other clinical trials that might affect the efficacy and safety of CML during this study.
Pregnant or lactating female.