A Real World Study of the Efficacy and Safety of Flumatinib Versus Imatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT05367765 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2400
Last updated 2022-05-10
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).
Conditions
- CML, Chronic Phase
Interventions
- DRUG
-
Flumatinib
Flumatinib 600mg orally daily
- DRUG
-
Imatinib
Imatinib 400mg orally daily (Reference drug instructions)
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jun Ma · Institute of Hematology and Oncology, Harbin The First Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-30
- Primary Completion
- 2027-04-30
- Completion
- 2028-04-30
Countries
- China
Study Locations
More Related Trials
-
Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
NCT04739826 ·Status: RECRUITING
-
Study of HS-10382 Combination in Patients With Chronic Myeloid Leukemia (CML)
NCT06530810 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
NCT04971226 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients
NCT02511340 ·Status: UNKNOWN ·Phase: PHASE2
-
Study to Evaluate Nilotinib in Chronic Myelogenous Leukemia (CML) Patients With SubOptimal Response
NCT01043874 ·Status: COMPLETED ·Phase: PHASE4
-
Compare Bosutinib To Imatinib In Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive CML
NCT00574873 ·Status: COMPLETED ·Phase: PHASE3
-
Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
NCT05071482 ·Status: TERMINATED ·Phase: PHASE4
-
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)
NCT00171899 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Imatinib in Chronic Myelogenous Patients Older Than 70 Years
NCT00219752 ·Status: COMPLETED ·Phase: PHASE2
-
Randomized Study Comparing the Effect of Dasatinib and Imatinib on Malignant Stem Cells in Chronic Myeloid Leukemia
NCT00852566 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Imatinib and Nilotinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase
NCT02272777 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
NCT00333840 ·Status: COMPLETED ·Phase: PHASE3
-
Nilotinib and Imatinib Mesylate in Treating Patients With Early Chronic Phase Chronic Myelogenous Leukemia
NCT00769327 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
NCT03578367 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
NCT01221376 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
NCT00362466 ·Status: TERMINATED ·Phase: PHASE3
-
Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib
NCT00644878 ·Status: TERMINATED ·Phase: PHASE2
-
Study of Chinese Newly Diagnosed Participants With Philadelphia Chromosome-Positive (Ph+) Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
NCT03509896 ·Status: COMPLETED
-
Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
NCT00519090 ·Status: TERMINATED ·Phase: PHASE3
-
Temsirolimus and Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia
NCT00101088 ·Status: TERMINATED ·Phase: PHASE1
-
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia (CML) Patients With Complete Cytogenetic Response After Imatinib as First Line Therapy
NCT00896129 ·Status: COMPLETED
-
Non-interventional Treatment Patterns Study in Chronic Phase Chronic Myelogenous Leukemia (CP-CML)
NCT01394666 ·Status: COMPLETED
-
Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia
NCT00103844 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT03654768 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs
NCT03459534 ·Status: RECRUITING ·Phase: PHASE3