Natural Killer Cells Reconstitution Kinetics Post Haploid... | NCT02978274

Studies
Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

NCT02978274

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Oct 5, 2020Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Natural Killer Cell Mediated Immunity

Interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Nov 28, 2016

First Submission Date that Met QC Criteria

Nov 29, 2016

First Posted Date

Nov 30, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2020

Last Update Posted Date

Oct 5, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaojun Huang,MD, Professor, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group		MMF withdrawal by engraftment post haplo-SCT	Drug: MMF
control group		MMF withdrawal by 2 month post haplo-SCT	Drug: MMF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MMF	Drug	MMF withdrawal by engraftment post haplo-SCT	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immune Reconstitution differences between two group		1 year

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangyu Zhao, M.D., PhD	Contact	+8610-88325949		xyz80421@126.com

Overall Officials

Name	Affiliation	Role
Xiaojun Huang, M.D., PhD	Peking University People's Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Institute of Hematology	Recruiting	Beijing	Beijing Municipality	100044	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31869417	Derived	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.
31015207	Derived