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

Validity and Safety Clinical Trial

Official title:

Flumatinib Efficacy and Safety for New Diagnosed Chronic Phase Chronic Myeloid Leukemia : A Prospective, Multi-center, Single Arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591197
• Other study ID #: HS-NF-2020
• Status: Recruiting
• Start date: December 9, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Na Xu, doctor
• Phone: 18620698390
• Email: sprenaa[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid, Chronic-Phase
• Validity and Safety

Locations

Country	Name	City	State
China	NanfangH	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MMR rates at 12 months	MMR(BCR/ABL(IS)<0.1%) at 12 months after treating	12 monts
Secondary	VEMR rates at 4 weeks	VEMR((BCR-ABL1/ABL1= 40% on the International Scale) at 4weeks after treating	4 weeks