A Multicentre, Retrospective Study to Evaluate the Outcom... | NCT04598789

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

NCT04598789

Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Status

Completed

Last Update Posted

Nov 26, 2021Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Leukemia, Myeloid

Interventions

no intervention

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2020Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Sep 1, 2021Actual

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Oct 16, 2020

First Posted Date

Oct 22, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2021

Last Update Posted Date

Nov 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Franca Fagioli, Director, Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaPrincipal Investigator

Lead Sponsor

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'AnnaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention, observational study

Measure	Description	Time Frame
acute GvHD incidence		2012-2017

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita		Turin		10126	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35092128	Derived	Berger M, Barone M, Spadea M, Saglio F, Pessolano R, Fagioli F. HSCT with mismatched unrelated donors: Bone marrow versus peripheral blood stem cells sources in pediatric patients. Pediatr Transplant. 2022 Jun;26(4):e14233. doi: 10.1111/petr.14233. Epub 2022 Jan 28.

ID	Term
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases