A Multicentre, Retrospective Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors
Sponsor
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna (Other)
Overall Status
Completed
CT.gov ID
NCT04598789
Collaborator
(none)
61
1
13.8
4.4
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
61 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Study to Evaluate the Outcome of HSCT Mismatch Unrelated Donors
Actual Study Start Date
:
Jul 7, 2020
Actual Primary Completion Date
:
Jun 30, 2021
Actual Study Completion Date
:
Sep 1, 2021
Outcome Measures
Primary Outcome Measures
- acute GvHD incidence [2012-2017]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita | Turin | Italy | 10126 |
Sponsors and Collaborators
- Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Prof. Franca Fagioli,
Director,
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
ClinicalTrials.gov Identifier:
NCT04598789
Other Study ID Numbers:
- Allo MM HSCT
First Posted:
Oct 22, 2020
Last Update Posted:
Nov 26, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: