NCT04991532

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

August 3, 2021

Last Update Submit

August 4, 2021

Conditions

Chronic Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

    2 years

Study Arms (2)

Dasatinib group

the CML patient treated with dasatinib

Imatinib group

the CML patient treated with imatinib

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CML-CP patients treated with TKIs

You may qualify if:

  • Age \>18 years old, gender is not limited
  • CML-CP patients treated with TKIs
  • No pregnancy was planned during the treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Dan Xu

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Xu

CONTACT

+86-20-61641615522111156@qq.com

Weixiang Lu

CONTACT

+86-20-61641615522111156@qq.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 5, 2021

Study Start

June 20, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)