Back to resultsA Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
Primary Purpose
CML, Chronic Phase
Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Flumatinib
Imatinib
Sponsored by
About this trial
This is an interventional treatment trial for CML, Chronic Phase focused on measuring Chronic Myeloid Leukemia, Flumatinib, BCR-ABL TKI, Real World, Prospective
Eligibility Criteria
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.
Sites / Locations
- Institute of Hematology and Oncology, Harbin The First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Flumatinib mesylate tablets
Imatinib mesylate tablets
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05367765
First Posted
May 5, 2022
Last Updated
May 5, 2022
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05367765
Brief Title
A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2022 (Anticipated)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CML, Chronic Phase
Keywords
Chronic Myeloid Leukemia, Flumatinib, BCR-ABL TKI, Real World, Prospective
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Flumatinib mesylate tablets
Arm Type
Experimental
Arm Title
Imatinib mesylate tablets
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Flumatinib
Intervention Description
Flumatinib 600mg orally daily
Intervention Type
Drug
Intervention Name(s)
Imatinib
Intervention Description
Imatinib 400mg orally daily (Reference drug instructions)
Primary Outcome Measure Information:
Title
Major molecular response (MMR) rate at 12 months
Description
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MMR rate of high-risk population treated at the end of 12 months
Description
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.
Time Frame
12 months
Title
MMR rate at 6, 24 and 36 Months
Description
MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale as measured by RQ-PCR.
Time Frame
6, 24 and 36 Months
Title
Complete Cytogenetic Response(CCyR) rate at 6, 12, 24 and 36 Months
Description
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.
Time Frame
6, 12, 24 and 36 Months
Title
Percentage of participants with transformation-free survival (TFS)
Description
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.
Time Frame
up to 60 Months
Title
Percentage of participants with progression free survival (PFS)
Description
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.
Time Frame
up to 60 Months
Title
Percentage of participants with overall survival (OS)
Description
OS was defined as the time between the first dose and the date of death from any cause.
Time Frame
up to 60 Months
Title
Incidence and severity of adverse events (AE)
Description
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.
Time Frame
From baseline until 28 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Ma
Phone
13304518000
Email
majun0322@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ma
Organizational Affiliation
Institute of Hematology and Oncology, Harbin The First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Hematology and Oncology, Harbin The First Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
201203
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Ma
Phone
13304518000
Email
majun0322@126.com
12. IPD Sharing Statement
Learn more about this trial
A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
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