Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia

Nanfang Hospital, Southern Medical University

Status: Enrolling

Conditions: Validity and Safety

Study type: Observational

Funder types: Other

Identifiers

NCT04591197

HS-NF-2020

Details and patient eligibility

About

The overall survival (OS)of Chronic myeloid leukemia (CML) has been significantly improved since the advent of Tyrosine kinase inhibitors (TKIs) .Nevertheless, there still exists a amount of patients who has poor response or intolerance for TKI drugs( Imatinib, dasatinib, nilotinib). Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib,and it aslo has better security when compared to other TKIs(Imatinib, dasatinib, nilotinib).It will be a better chioce for CML patients.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old, both male and female;
2. New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
3. Within half a year after diagnosis of CML;
4. Previous TKIs treatment was less than 2 weeks;
5. The pregnant test of female patients was negative (within 7 days before medication before enrollment);
6. Informed consent of the patient or his legal representative

Exclusion criteria

1. T315I mutation is known to exist;
2. Rare atypical transcript types that cannot be standardized internationally;
3. Received TKI drugs for more than 2 weeks before enrollment;
4. Received interferon therapy for more than 3 months before enrollment;
5. Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
6. patients who participate in other clinical studies at the same time;
7. patients who having had major surgery or not recovered from surgery within 4 weeks;
8. patients who having history of malignant tumor
9. Woman who is pregnant or nursing
10. Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) > 3;
11. Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
12. A clear history of neurological or psychiatric disorders, including epilepsy or dementia