A Prospective Observational Study for Evaluating CGVHD
GITMO-GVCrOSy
1 other identifier
observational
248
1 country
27
Brief Summary
Prospective, observational, multicentre, spontaneous, non-interventional study This study will evaluate all consecutive patients who develop chronic graft-versus-host disease, reported by the Italian GITMO centers according to a standardized Web platform for real-time, onsite data collection. The platform for data collection will be based on a software prototype developed by the Clinica di Ematologia di Ancona Transplant Center for the management of patients with chronic graft-versus-host disease. This software has been integrated with algorithms that automatically determine: severity of chronic graft-versus-host disease and overall response according to the 2015 NIH consensus criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
27 active sites
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
First Submitted
Initial submission to the registry
December 6, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2016
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2022
CompletedNovember 25, 2022
November 1, 2022
5.2 years
December 6, 2016
November 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Failure free survival (FFS)
To estimate the failure free survival measured from the start of 1st line immunosuppressive treatment for cGVHD, defined as the probability of survival free of any of the following events: cGVHD progression, need of a new immunosuppressive treatment, need of treatment dose escalation, relapse of the underlying hematological disease, severe (CTCAE grade 3-4) toxicity.
Measured from the start of 1st line immunosuppressive treatment for cGVHD until the date of first documented progression or date of death from any cause whichever came first, assessed up to 1 years from transplant
Secondary Outcomes (8)
Response rate (RR)
3 and 6 months
Incidence and grade of cGVHD
at 1 year from transplant
relapse
1 year from transplant
non-relapse mortality
1 year from transplant
treatment change
measured from the start of first-line and subsequent treatment lines for 1 year
- +3 more secondary outcomes
Study Arms (1)
Patients with cGVHD
All consecutive patients undergoing allogenic stem cell transplant for any underlying disease who develop chronic graft-versus-host disease (cGVHD)
Eligibility Criteria
All consecutive patients undergoing sllogenic stem cell transplant for any underlyng disease who develop chronic graft-versus-host disease (cGVHD)
You may qualify if:
- Any age
- All patients who develop cGVHD (any grade) by the NIH criteria after allogeneic transplantation
- Written and signed informed consent
You may not qualify if:
- Absence of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Azienda Ospedaliera SS Antonio e Biagio
Alessandria, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona, Italy
Policlinico di Bari-Ematologia con trapianti
Bari, Italy
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo, Italy
Ospedale San Orsola
Bologna, Italy
Ospedale Regionale Generale- Divisione Ematologia
Bolzano, Italy
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia, Italy
Ospedale Ferrarotto - Ematologia
Catania, Italy
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo, Italy
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
Florence, Italy
Ospedale Gaslini
Genova, Italy
Osp. Card. Panico
Lecce, Italy
Ospedale Maggiore - Policlinico
Milan, Italy
Ospedale San Raffaele
Milan, Italy
CTMO Fond MBBM Clinica pediatrica
Monza, Italy
Uoc Sit Tmo
Napoli, Italy
Azienda ospedaliera Universitaria di Parma
Parma, Italy
Ospedale G. Da Saliceto di Piacenza
Piacenza, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria, Italy
Arciospedale S. M. Novella
Reggio Emilia, Italy
Cattedra di Ematologia - Policlinico Umberto I
Roma, Italy
A.O.U. Citta della Salute e della Scienza
Torino, Italy
Ospedale Regina Margherita
Torino, Italy
A.O. Santa Maria della Misericordia
Udine, Italy
Policlinico GB Rossi
Verona, Italy
Ospedale S. Bortolo-Divisione Ematologia
Vicenza, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Attilio Olivieri, MD
AOU Ospedali Riuniti di Ancona
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2016
First Posted
December 14, 2016
Study Start
September 1, 2017
Primary Completion
November 22, 2022
Study Completion
November 22, 2022
Last Updated
November 25, 2022
Record last verified: 2022-11