A Multicentre, Retrospective Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors

November 24, 2021 updated by: Prof. Franca Fagioli, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors

The primary endpoint of the study was the acute GvHD incidence, the secondary endpoints were chronic GvHD incidence, overall survival (OS), transplant related mortality (TRM) incidence, relapse incidence (RI) and neutrophil and platelets engraftment after GvHD prophylaxis with ATG-CSA-MTX or PTCy-MMF-FK506

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

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

  • Italy
      • Turin, Italy, 10126
        • AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

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

Sampling Method

Probability Sample

Study Population

Patients (children and adults) having HSCT from a one-antigen mismatch unrelated donors and treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017

Description

Inclusion Criteria:

  • children and adults)
  • HSCT from a one-antigen mismatch unrelated donors
  • Treated at the Centro Trapianti Metropolitano di Torino between 2012 to 2017

Exclusion Criteria: none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acute GvHD incidence
Time Frame: 2012-2017
2012-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

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 (Actual)

July 7, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allo MM HSCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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