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

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ClinicalTrials.gov Identifier: NCT04991532
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Dan Xu, Nanfang Hospital of Southern Medical University

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
Chronic Myeloid Leukemia

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

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Study Type : Observational
Estimated 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 : June 20, 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022


Group/Cohort
Dasatinib group
the CML patient treated with dasatinib
Imatinib group
the CML patient treated with imatinib



Primary Outcome Measures :
  1. NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years [ Time Frame: 2 years ]
    NK cells and T cell activation subsets in CML-CP patients treated with TKI for 2 years



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CML-CP patients treated with TKIs
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04991532


Contacts
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Contact: Dan Xu +86-20-61641615 522111156@qq.com
Contact: Weixiang Lu +86-20-61641615 522111156@qq.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Dan Xu    +86-20-61641615    522111156@qq.com   
Contact: weixiang lu    +86-20-61641615    522111156@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: Dan Xu Nanfang Hospital of Southern Medical University
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Responsible Party: Dan Xu, professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04991532    
Other Study ID Numbers: NFEC-2021-130
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases