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

Status Not yet recruiting

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).

Clinical Trial 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

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT05367765
Study type	Interventional
Source	Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact	Jun Ma
Phone	13304518000
Email	majun0322@126.com
Status	Not yet recruiting
Phase	Phase 4
Start date	April 30, 2022
Completion date	April 30, 2028

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06409936` - PEARL Study: PotEntial of Asciminib in the eaRly Treatment of CML	Phase 2
Recruiting	`NCT05353205` - A Study of the Efficacy and Safety of Flumatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.	Phase 4
Not yet recruiting	`NCT06121765` - Metabolic Alternation and Clinicohematological Characteristic in Chronic Phase CML in Patient Treated With TKI
Not yet recruiting	`NCT06423911` - A Phase 3 Registrational Study of Olverembatinib (HQP1351) in Patients With CML	Phase 3
Recruiting	`NCT03459534` - A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs	Phase 3
Completed	`NCT03885830` - Precision Dosing of Tyrosine Kinase Inhibitors in CML Patients
Completed	`NCT04883125` - Value of Using Pioglitazone in Chronic Myeloid Leukemia Treatment	Phase 2
Recruiting	`NCT02949570` - Study to Assess Efficacy and Safety of Inecalcitol in Imatinib-Treated Residual Chronic Myeloid Leukaemia: INIM Study	Phase 2
Recruiting	`NCT05367700` - A Study of HS-10382 in Patients With Chronic Myeloid Leukemia.	Phase 1