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

NCT ID: NCT05152537

Last Updated: 2022-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Folate CML Treatment-free Remission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Hospital of Nantong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Liu, Doctorate

Role: STUDY_CHAIR

Affiliated Hospital of Nantong University

Locations

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Affliated Hospital of Nantong University

Nantong, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Liu, Doctorate

Role: CONTACT

+8613951300660

Lu Zhou, Doctorate

Role: CONTACT

18761720268

Facility Contacts

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Hong N Liu, Doctorate

Role: primary

+8613951300660

Lu Zhou, Doctorate

Role: backup

18761720268

Other Identifiers

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AHNTU-CML-001

Identifier Type: -

Identifier Source: org_study_id

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