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

NCT04591197 | Unknown

• 1 other identifier: HS-NF-2020
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• MMR rates at 12 months

  MMR(BCR/ABL(IS)\<0.1%) at 12 months after treating

  12 monts

Secondary Outcomes (1)

• VEMR rates at 4 weeks

  4 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

New diagnosed CML-CP patients who are more than 18 years old.

You may qualify if:

• Age ≥ 18 years old, both male and female;
• New Diagnosed Chronic Phase Chronic Myeloid Leukemia.
• Within half a year after diagnosis of CML;
• Previous TKIs treatment was less than 2 weeks;
• The pregnant test of female patients was negative (within 7 days before medication before enrollment);
• Informed consent of the patient or his legal representative

You may not qualify if:

• T315I mutation is known to exist;
• Rare atypical transcript types that cannot be standardized internationally;
• Received TKI drugs for more than 2 weeks before enrollment;
• Received interferon therapy for more than 3 months before enrollment;
• Received other anti-CML drugs (except hydroxyurea) for more than 2 weeks or surgical treatment (including hematopoietic stem cell transplantation)
• patients who participate in other clinical studies at the same time;
• patients who having had major surgery or not recovered from surgery within 4 weeks;
• patients who having history of malignant tumor
• Woman who is pregnant or nursing
• Eastern Cooperative Oncology Group Physical Performance Status Score (ECOG PS) \> 3;
• Patients known to be allergic or contraindicated to the study drug (APIs and/or excipients).
• A clear history of neurological or psychiatric disorders, including epilepsy or dementia

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanfangH

Guangzhou, Guangdong, 510515, China

RECRUITING

Central Study Contacts

Na Xu, doctor

CONTACT

18620698390; sprenaa@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 19, 2020
• Study Start: December 9, 2020
• Primary Completion: January 1, 2024
• Study Completion: December 30, 2024
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

CN (1)