FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor（TKI）Stopping in Chronic Myeloid Leukemia

CML Clinical Trial

— NTU-CML-001  

Official title:

A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152537
• Other study ID #: AHNTU-CML-001
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Affiliated Hospital of Nantong University
• Contact: Hong Liu, Doctorate
• Phone: +8613951300660
• Email: hongliu63[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For patients with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved a stable deep molecular response (DMR) using BCR-ABL1 tyrosine kinase inhibitors (TKIs), treatment-free remission (TFR) following TKI cessation is an emerging goal. However, about half of the patients relapsed after TKI discontinuation. There is no definite examinations to predict the outcome of TKI discontinuation. Investigators aim to study the relationship between FLOR3 SNP rs139130389 and the outcome of TKI discontinuation.

Description:

Investigators aim to detect FOLR3 SNP rs139130389, and establish its correlation with patients' treatment response, remission time, TKI resistance and the outcome of TKI stopping.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient signs the informed consent form

2. Age over 18, male or female

3. The patient was diagnosed as chronic phase of CML.

4. ECoG score 0-2

5. Receive TKI treatment for at least 4 years and continuously obtain MR4 or mr4.5 for at least 3 years.

6. The subjects fully understand and comply with the requirements of the research scheme and are willing to complete the research as planned.

Exclusion Criteria:

NA

Related Conditions & MeSH terms

• CML
• Folate
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Locations

Country	Name	City	State
China	Affliated Hospital of Nantong University	Nantong

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	treatment-free remission or relapse	Observe whether the patients were in remission or relapse 1 year after drug withdrawal	1 year