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

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: CML, Chronic Phase
• Intervention / Treatment: Drug: Flumatinib; Drug: Imatinib

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 Type: Interventional
• Enrollment (Anticipated): 2400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Ma; Phone Number: 13304518000; Email: majun0322@126.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 201203
      • Institute of Hematology and Oncology, Harbin The First Hospital
      • Contact: Jun Ma; Phone Number: 13304518000; Email: majun0322@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Jun Ma, Institute of Hematology and Oncology, Harbin The First Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2022
• Primary Completion (Anticipated): April 30, 2027
• Study Completion (Anticipated): April 30, 2028

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic Myeloid Leukemia; Prospective; Real World; Flumatinib; BCR-ABL TKI
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate; HH-GV-678
• Other Study ID Numbers: HS-10096-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No