Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

NCT ID: NCT02978274

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Natural Killer Cell Mediated Immunity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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experimental group

MMF withdrawal by engraftment post haplo-SCT

MMF

Intervention Type DRUG

MMF withdrawal by engraftment post haplo-SCT

control group

MMF withdrawal by 2 month post haplo-SCT

MMF

Intervention Type DRUG

MMF withdrawal by 2 month post haplo-SCT

Interventions

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MMF

MMF withdrawal by engraftment post haplo-SCT

Intervention Type DRUG

MMF

MMF withdrawal by 2 month post haplo-SCT

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiaojun Huang,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaojun Huang, M.D., PhD

Role: STUDY_CHAIR

Peking University People's Hospital

Locations

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Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiangyu Zhao, M.D., PhD

Role: CONTACT

+8610-88325949

Facility Contacts

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Xiangyu Zhao, M.D., PhD

Role: primary

+8610-88325949

References

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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.

Reference Type DERIVED
PMID: 31869417 (View on PubMed)

Kong 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.

Reference Type DERIVED
PMID: 31015207 (View on PubMed)

Other Identifiers

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2016PHB038-01

Identifier Type: -

Identifier Source: org_study_id

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