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

• Status: Not yet recruiting
• Trial end date: 2028-04-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Treatments: HH-GV-678; Imatinib Mesylate

Criteria

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.