NTU-CML-001: FLOR3 Gene Polymorphism in Predicting Outcomes of Tyrosine Kinase Inhibitor(TKI)Stopping in Chronic Myeloid Leukemia

Sponsor
Affiliated Hospital of Nantong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05152537
Collaborator
(none)
15
1
35
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    15 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multicenter Prospective Cohort Study of FLOR3 Gene Polymorphism in Predicting Outcomes of TKI-stopping in Chronic Myeloid Leukemia
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. treatment-free remission or relapse [1 year]

      Observe whether the patients were in remission or relapse 1 year after drug withdrawal

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Affliated Hospital of Nantong University Nantong China

    Sponsors and Collaborators

    • Affiliated Hospital of Nantong University

    Investigators

    • Study Chair: Hong Liu, Doctorate, Affiliated Hospital of Nantong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Affiliated Hospital of Nantong University
    ClinicalTrials.gov Identifier:
    NCT05152537
    Other Study ID Numbers:
    • AHNTU-CML-001
    First Posted:
    Dec 10, 2021
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Affiliated Hospital of Nantong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 3, 2022