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

NCT ID: NCT04591197

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-09
• Study Completion Date: 2024-12-30

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.

Conditions

Validity and Safety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

xuna

Associate chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NanfangH

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Na Xu, doctor

Role: CONTACT

sprenaa@163.com

18620698390

Facility Contacts

xu na, doctor

Role: primary

sprenaa@163.com

18620698390

Other Identifiers

HS-NF-2020

Identifier Type: -

Identifier Source: org_study_id