NCT04598789

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

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

July 7, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

October 16, 2020

Last Update Submit

November 24, 2021

Conditions

Leukemia, Myeloid

Outcome Measures

Primary Outcomes (1)

  • acute GvHD incidence

    2012-2017

Interventions

no interventionOTHER

no intervention, observational study

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita

Turin, 10126, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35092128DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 22, 2020

Study Start

July 7, 2020

Primary Completion

June 30, 2021

Study Completion

September 1, 2021

Last Updated

November 26, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

IT(1)