NCT02412423

Brief Summary

In "beijing model" for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in "beijing model".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 5, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

April 5, 2015

Last Update Submit

September 15, 2020

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • rate of acute GVHD

    participants will be followed for an expected average of 365 days

Secondary Outcomes (3)

  • rate of non-relapse mortality

    participants will be followed for an expected average of 365 days

  • rate of relapse

    participants will be followed for an expected average of 365 days

  • probability of survival

    participants will be followed for an expected average of 365 days

Study Arms (1)

treatment group

EXPERIMENTAL

post-transplantation cyclophosphamide

Drug: post-transplantation cyclophosphamide

Interventions

post-transplantation cyclophosphamideDRUG
treatment group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • haploidentical patients from maternal or collateral donors

You may not qualify if:

  • uncontrolled infection before transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

Related Publications (1)

  • Wang Y, Wu DP, Liu QF, Xu LP, Liu KY, Zhang XH, Yu WJ, Xu Y, Huang F, Huang XJ. Low-dose post-transplant cyclophosphamide and anti-thymocyte globulin as an effective strategy for GVHD prevention in haploidentical patients. J Hematol Oncol. 2019 Sep 3;12(1):88. doi: 10.1186/s13045-019-0781-y.

    PMID: 31481121DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director

Study Record Dates

First Submitted

April 5, 2015

First Posted

April 9, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

March 1, 2017

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations

CN(1)