Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

• Sponsor: Peking University People's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02978274
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 93
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Natural Killer Cell Mediated Immunity	Drug: MMF; Drug: MMF

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation
• Actual Study Start Date: Mar 1, 2015
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Immune Reconstitution differences between two group [1 year]

Secondary Outcome Measures

1. Cumulative incidence of Infection differences between two group [1 year]

2. Cumulative incidence of acute GVHD differences between two group [100 day]

3. Cumulative incidence of chronic GVHD differences between two group [1 year]

4. Cumulative incidence of TRM differences between two group [1 year]

5. Cumulative incidence of relapse differences between two group [1 year]

6. DFS differences between two group [1 year]

7. OS differences between two group [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Institute of Hematology	Beijing	Beijing	China	100044

Sponsors and Collaborators

• Peking University People's Hospital

Investigators

• Study Chair: Xiaojun Huang, M.D., PhD, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xiaojun Huang,MD, Professor, Peking University People's Hospital
• ClinicalTrials.gov Identifier: NCT02978274
• Other Study ID Numbers: 2016PHB038-01
• First Posted: Nov 30, 2016
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

No Results Posted as of Oct 5, 2020