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

Recruiting

• Conditions: Validity and Safety

• Registration Number: NCT04591197
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Study Start: 2020-12-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MMR rates at 12 months	12 monts	MMR(BCR/ABL(IS)\<0.1%) at 12 months after treating

Secondary Outcome Measures

Name	Time	Method
VEMR rates at 4 weeks	4 weeks	VEMR((BCR-ABL1/ABL1≤ 40% on the International Scale) at 4weeks after treating

Trial Locations

Locations (1)

NanfangH; 🇨🇳 Guangzhou, Guangdong, China