Clinical trial · Observational
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia
Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Validity and Safety | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MMR rates at 12 months
- timeFrame
- 12 monts
- description
- MMR(BCR/ABL(IS)\<0.1%) at 12 months after treating
Secondary outcomes (1)
- measure
- VEMR rates at 4 weeks
- timeFrame
- 4 weeks
- description
- VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available