Validity and Safety
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MMR rates at 12 months | 12 monts | MMR(BCR/ABL(IS)\<0.1%) at 12 months after treating |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VEMR rates at 4 weeks | 4 weeks | VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating |
Countries
China
Contacts
Primary ContactNa Xu, doctor
Outcome results
None listed