Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors

September 15, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital
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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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, China, 100044
        • Peking University People's Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • haploidentical patients from maternal or collateral donors

Exclusion Criteria:

  • uncontrolled infection before transplant

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

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
post-transplantation cyclophosphamide
Drug: post-transplantation cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of acute GVHD
Time Frame: participants will be followed for an expected average of 365 days
participants will be followed for an expected average of 365 days

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of non-relapse mortality
Time Frame: participants will be followed for an expected average of 365 days
participants will be followed for an expected average of 365 days
rate of relapse
Time Frame: participants will be followed for an expected average of 365 days
participants will be followed for an expected average of 365 days
probability of survival
Time Frame: participants will be followed for an expected average of 365 days
participants will be followed for an expected average of 365 days

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

March 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

April 5, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015PHB016-01

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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