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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Flumatinib
  • Imatinib

Treatment groups

2,400 Participants
are divided into 2 treatment groups