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

CML, Chronic Phase Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05367765
• Other study ID #: HS-10096-401
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 30, 2022
• Est. completion date: April 30, 2028

Study information

• Verified date: April 2022
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Jun Ma
• Phone: 13304518000
• Email: majun0322[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2400
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CML, Chronic Phase
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Flumatinib
Flumatinib 600mg orally daily
• Imatinib
Imatinib 400mg orally daily (Reference drug instructions)

Locations

Country	Name	City	State
China	Institute of Hematology and Oncology, Harbin The First Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	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.	12 months
Secondary	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.	6, 24 and 36 Months
Secondary	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.	6, 12, 24 and 36 Months
Secondary	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.	up to 60 Months
Secondary	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.	up to 60 Months
Secondary	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.	up to 60 Months
Secondary	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.	From baseline until 28 days after the last dose