Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

• Conditions: Natural Killer Cell Mediated Immunity
• Interventions: Drug: MMF

• Registration Number: NCT02978274
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.

Detailed Description

Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-05
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation

Exclusion Criteria

• NR or refractory AML/ALL before transplantation donors from mother or collateral related

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	MMF	MMF withdrawal by 2 month post haplo-SCT
experimental group	MMF	MMF withdrawal by engraftment post haplo-SCT

Primary Outcome Measures

Name	Time	Method
Immune Reconstitution differences between two group	1 year

Secondary Outcome Measures

Name	Time	Method
Cumulative incidence of TRM differences between two group	1 year
OS differences between two group	1 year
Cumulative incidence of chronic GVHD differences between two group	1 year
Cumulative incidence of Infection differences between two group	1 year
Cumulative incidence of relapse differences between two group	1 year
DFS differences between two group	1 year
Cumulative incidence of acute GVHD differences between two group	100 day

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China