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Dasatinib Down-regulates the Expression of PD-1 and Enhances Killing pH + Leukemia Stem Cells

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04991532
Collaborator
(none)
324
Enrollment
1
Location
17.4
Anticipated Duration (Months)
18.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Research on the mechanism of dasatinib down-regulates the expression of PD-1 in CMV-activated NKG2C+NK cells and enhances killing pH + leukemia stem cells.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Some patients with CML can withdraw from TKIs after treatment, and the mechanism might be related to the effect of memory NK cells on anti-Ph+ leukemic stem cells (LSCs). Dasatinib affects immune through several pathways including the expression of PD1 in immune cells. Our previous work showed increased NKG2C+ NK cells were found in cases with CMV-DNA+ who suffered Ph+ leukemia and received Dasatinib, and these memory NK cells have anti-LSCs activity. We hypothesize that: CMV infection activates NKG2C+ memory NK cells proliferation; Dasatinib down-regulates the expression of PD1 in PD1+NKG2C+ NK cell subsets and then enhances anti-LSCs activity of these cells. In this study, the effect of Dasatinib on CMV-activated NKG2C+ cell subsets and its mechanism will be studies. Besides, the different NKG2C+ cell subsets on LSCs will be compared. This study might be helpful to clarify the mechanism of TKI withdrawal and to offer foundation for CMV and Ph+ ALL treatment strategies

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    324 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Research on the Mechanism of Dasatinib Down-regulates the Expression of PD-1 in CMV-activated NKG2C+NK Cells and Enhances Killing pH + Leukemia Stem Cells.
    Actual Study Start Date :
    Jun 20, 2021
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Dasatinib group

    the CML patient treated with dasatinib
    Imatinib group

    the CML patient treated with imatinib

    Outcome Measures

    Primary Outcome Measures

    1. NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years [2 years]

      NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age >18 years old, gender is not limited

    2. CML-CP patients treated with TKIs

    3. No pregnancy was planned during the treatment

    Exclusion Criteria:

    1.The researcher judged that it was not suitable to participate in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Hematology,Nanfang Hospital, Southern Medical University Guangzhou Guangdong China 510515

    Sponsors and Collaborators

    • Nanfang Hospital of Southern Medical University

    Investigators

    • Principal Investigator: Dan Xu, Nanfang Hospital of Southern Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dan Xu, professor, Nanfang Hospital of Southern Medical University
    ClinicalTrials.gov Identifier:
    NCT04991532
    Other Study ID Numbers:
    • NFEC-2021-130
    First Posted:
    Aug 5, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive

    Study Results

    No Results Posted as of Aug 5, 2021