Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation
1 other identifier
observational
200
1 country
1
Brief Summary
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedOctober 5, 2020
September 1, 2020
6.8 years
November 28, 2016
September 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Immune Reconstitution differences between two group
1 year
Secondary Outcomes (7)
Cumulative incidence of Infection differences between two group
1 year
Cumulative incidence of acute GVHD differences between two group
100 day
Cumulative incidence of chronic GVHD differences between two group
1 year
Cumulative incidence of TRM differences between two group
1 year
Cumulative incidence of relapse differences between two group
1 year
- +2 more secondary outcomes
Study Arms (2)
experimental group
MMF withdrawal by engraftment post haplo-SCT
control group
MMF withdrawal by 2 month post haplo-SCT
Interventions
Eligibility Criteria
AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
You may qualify if:
- AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation
You may not qualify if:
- NR or refractory AML/ALL before transplantation donors from mother or collateral related
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044, China
Related Publications (2)
Zhao XY, Yu XX, Xu ZL, Cao XH, Huo MR, Zhao XS, Chang YJ, Wang Y, Zhang XH, Xu LP, Liu KY, Huang XJ. Donor and host coexpressing KIR ligands promote NK education after allogeneic hematopoietic stem cell transplantation. Blood Adv. 2019 Dec 23;3(24):4312-4325. doi: 10.1182/bloodadvances.2019000242.
PMID: 31869417DERIVEDKong Y, Wang Y, Zhang YY, Shi MM, Mo XD, Sun YQ, Chang YJ, Xu LP, Zhang XH, Liu KY, Huang XJ. Prophylactic oral NAC reduced poor hematopoietic reconstitution by improving endothelial cells after haploidentical transplantation. Blood Adv. 2019 Apr 23;3(8):1303-1317. doi: 10.1182/bloodadvances.2018029454.
PMID: 31015207DERIVED
Biospecimen
PB of patients post transplantation
Study Officials
- STUDY CHAIR
Xiaojun Huang, M.D., PhD
Peking University People's Hospital
Central Study Contacts
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
November 28, 2016
First Posted
November 30, 2016
Study Start
March 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
October 5, 2020
Record last verified: 2020-09