Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

September 30, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital

Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University Institute of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
experimental group
MMF withdrawal by engraftment post haplo-SCT
Drug: MMF
MMF withdrawal by engraftment post haplo-SCT
Drug: MMF
MMF withdrawal by 2 month post haplo-SCT
control group
MMF withdrawal by 2 month post haplo-SCT
Drug: MMF
MMF withdrawal by engraftment post haplo-SCT
Drug: MMF
MMF withdrawal by 2 month post haplo-SCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune Reconstitution differences between two group
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cumulative incidence of Infection differences between two group
Time Frame: 1 year
1 year
Cumulative incidence of acute GVHD differences between two group
Time Frame: 100 day
100 day
Cumulative incidence of chronic GVHD differences between two group
Time Frame: 1 year
1 year
Cumulative incidence of TRM differences between two group
Time Frame: 1 year
1 year
Cumulative incidence of relapse differences between two group
Time Frame: 1 year
1 year
DFS differences between two group
Time Frame: 1 year
1 year
OS differences between two group
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria

November 29, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016PHB038-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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