Chronic Graft-Versus-Host DiseaseGITMO-GVCrOSyNCT02991846
A Prospective Observational Study for Evaluating CGVHD
An observational study of Chronic Graft-Versus-Host Disease, run by Gruppo Italiano Trapianto di Midollo Osseo at 27 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Graft-Versus-Host Disease
- How many people
- 248 participants
- Where
- 27 sitesItaly
- Study dates
- 1 Sep 2017to 22 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing sllogenic stem cell transplant for any underlyng disease who develop chronic graft-versus-host disease (cGVHD)
Who may be able to join
- Any age
- All patients who develop cGVHD (any grade) by the NIH criteria after allogeneic transplantation
- Written and signed informed consent
Who cannot join
- Absence of informed consent
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
Azienda Ospedaliera SS Antonio e Biagio
Alessandria
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Ancona
Policlinico di Bari-Ematologia con trapianti
Bari
Divisione di Ematologia - Ospedali Papa Giovanni XXIII
Bergamo
Ospedale San Orsola
Bologna
Ospedale Regionale Generale- Divisione Ematologia
Bolzano
AO Spedali Civili di Brescia- USD - TMO Adulti
Brescia
Ospedale Ferrarotto - Ematologia
Catania
S.C. Ematologia - Azienda Ospedaliera S. Croce e Carle
Cuneo
Cattedra di Ematologia - Azienda Ospedaliera di Careggi
Florence
Ospedale Gaslini
Genova
Osp. Card. Panico
Lecce
Ospedale Maggiore - Policlinico
Milan
Ospedale San Raffaele
Milan
CTMO Fond MBBM Clinica pediatrica
Monza
Uoc Sit Tmo
Naples
Azienda ospedaliera Universitaria di Parma
Parma
Ospedale G. Da Saliceto di Piacenza
Piacenza
Azienda Ospedaliero Universitaria Pisana
Pisa
Centro Unico Regionale Trapianti di Midollo Osseo - Ospedale Bianchi-Melacino-Morelli
Reggio Calabria
Arciospedale S. M. Novella
Reggio Emilia
Cattedra di Ematologia - Policlinico Umberto I
Roma
A.O.U. Citta della Salute e della Scienza
Torino
Ospedale Regina Margherita
Torino
A.O. Santa Maria della Misericordia
Udine
Policlinico GB Rossi
Verona
Ospedale S. Bortolo-Divisione Ematologia
Vicenza
About this study
Official title: A Prospective Observational Study for Evaluating Incidence, Severity and Outcomes of Chronic Graft-versus-Host Disease According to 2015 NIH Consensus Criteria
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.
Read the detailed description
Chronic Graft-versus-Host Disease represents the first cause of transplant-related mortality and reduced quality of life after transplant (HSCT). The epidemiology of Chronic Graft-versus-Host Disease is largely unknown; moreover, diagnosis of Chronic Graft-versus-Host Disease can be easily missed because its onset is often late in the post-transplant period, requires specific follow up, and general practitioners are usually not familiar with this entity. Successful treatment of Chronic Graft-versus-Host Disease represents an unmet clinical need in the field of allogeneic transplantation. Steroids are standard treatment, but up to 60% of the patients will require second-line treatment but there is no standard second-line treatment for Chronic Graft-versus-Host Disease steroid refractory. To help standardise the management Chronic Graft-versus-Host Disease, the NIH Consortium proposed consensus definitions for diagnosis, scoring and response criteria in 2006 revised in 2015 which offers a shared framework to study this rare disease. These criteria are not yet validated and thus not suitable for clinical trials.
This study is prospective, observational, multicentre, spontaneous, non-interventional study that 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, on-site data collection. The platform for data collection will be based on a software prototype developed by the 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 by the 2015 NIH consensus criteria. Historical controls to compare Chronic Graft-versus-Host Disease incidence, toxicities, response rate and hard outcomes will be used.
The aim of this project is to evaluate prospectively the long-term effectiveness of different therapies by the hard outcome "failure free survival" commonly considered the most reliable one. The failure free survival is the result of a number of factors that influence the treatment failure and has been shown a reliable predictor of long-term survival. Main cause of failure is the change in immunosuppressive treatment although recurrent disease, treatment toxicity and mortality from Chronic Graft-versus-Host Disease (or other infectious complications) also contribute to failure free survival. Second, we aim to evaluate the prognostic ability of the latest NIH response criteria to predict main hard survival outcomes and to assess their suitability as a tool for decision-making that ultimately leads to treatment changes. Finally, we aim to evaluate the feasibility of the use of an electronic tool for data collection in daily clinical practice.
- Conditions
- Chronic Graft-Versus-Host Disease
- Keywords
- chronic graft-versus-host disease cGVHD, Hematopoietic stem cell transplantation HSCT, NIH consensus criteria, GITMO
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cGVHD | All consecutive patients undergoing allogenic stem cell transplant for any underlying disease who develop chronic graft-versus-host disease (cGVHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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)
Global and organ-specific response rate (RR), evaluated 3 and 6 months after starting systemic treatment, by the 2015 NIH criteria
Measured: 3 and 6 months
Incidence and grade of cGVHD
Incidence and grade of cGVHD, by the 2015 NIH criteria at 1 year after Hematopoietic stem cell transplantation (HSCT)
Measured: at 1 year from transplant
relapse
Cumulative incidence of relapse of underlying haematological malignancy
Measured: 1 year from transplant
non-relapse mortality
Cumulative incidence of non-relapse mortality (NRM), defined as any death not due to disease relapse or progression
Measured: 1 year from transplant
treatment change
Cumulative incidence of treatment change, measured from the start of first-line and subsequent treatment lines
Measured: measured from the start of first-line and subsequent treatment lines for 1 year
Successful withdrawal of immunosuppressive treatment
Cumulative incidence of successful withdrawal of immunosuppressive treatment, measured from the start of first-line and subsequent treatment lines.
Measured: Measured from the start of firs-tline and subsequent treatment lines for 1 year
Overall Survival
Overall Survival, measured from cGVHD diagnosis.
Measured: measured from cGVHD diagnosis until 1 year
Severe Adverse Events (SAE) and Toxicities
Incidence of Severe Adverse Events (SAE), toxicities (by the Common Terminology Criteria for Adverse Events - CTCAE), infections during treatments.
Measured: Measured from first treatment for cGVHD until 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start1 Sep 2017
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Trapianto di Midollo Osseo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Attilio Olivieri, MD, Principal investigator, AOU Ospedali Riuniti di Ancona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991846
- Sponsor's protocol ID
- GITMO-GVCrOSy
- Acronym
- GITMO-GVCrOSy
- Status last verified
- Nov 2022
- First submitted
- 6 Dec 2016
- Last updated
- 25 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study for Evaluating Incidence, Severity and Outcomes of Chronic Graft-versus-Host Disease According to 2015 NIH Consensus Criteria
- ClinicalTrials.gov ID
- NCT02991846
- Acronym / sponsor ID
- GITMO-GVCrOSy / GITMO-GVCrOSy
- Conditions
- Chronic Graft-Versus-Host Disease
- Keywords
- chronic graft-versus-host disease cGVHD, Hematopoietic stem cell transplantation HSCT, NIH consensus criteria, GITMO
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Gruppo Italiano Trapianto di Midollo OsseoUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic Graft-versus-Host Disease represents the first cause of transplant-related mortality and reduced quality of life after transplant (HSCT). The epidemiology of Chronic Graft-versus-Host Disease is largely unknown; moreover, diagnosis of Chronic Graft-versus-Host Disease can be easily missed because its onset is often late in the post-transplant period, requires specific follow up, and general practitioners are usually not familiar with this entity. Successful treatment of Chronic Graft-versus-Host Disease represents an unmet clinical need in the field of allogeneic transplantation. Steroids are standard treatment, but up to 60% of the patients will require second-line treatment but there is no standard second-line treatment for Chronic Graft-versus-Host Disease steroid refractory. To help standardise the management Chronic Graft-versus-Host Disease, the NIH Consortium proposed consensus definitions for diagnosis, scoring and response criteria in 2006 revised in 2015 which offers a shared framework to study this rare disease. These criteria are not yet validated and thus not suitable for clinical trials.
This study is prospective, observational, multicentre, spontaneous, non-interventional study that 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, on-site data collection. The platform for data collection will be based on a software prototype developed by the 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 by the 2015 NIH consensus criteria. Historical controls to compare Chronic Graft-versus-Host Disease incidence, toxicities, response rate and hard outcomes will be used.
The aim of this project is to evaluate prospectively the long-term effectiveness of different therapies by the hard outcome "failure free survival" commonly considered the most reliable one. The failure free survival is the result of a number of factors that influence the treatment failure and has been shown a reliable predictor of long-term survival. Main cause of failure is the change in immunosuppressive treatment although recurrent disease, treatment toxicity and mortality from Chronic Graft-versus-Host Disease (or other infectious complications) also contribute to failure free survival. Second, we aim to evaluate the prognostic ability of the latest NIH response criteria to predict main hard survival outcomes and to assess their suitability as a tool for decision-making that ultimately leads to treatment changes. Finally, we aim to evaluate the feasibility of the use of an electronic tool for data collection in daily clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cGVHD | – | –All consecutive patients undergoing allogenic stem cell transplant for any underlying disease who develop chronic graft-versus-host disease (cGVHD) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing sllogenic stem cell transplant for any underlyng disease who develop chronic graft-versus-host disease (cGVHD)
Key inclusion criteria (3 listed)
- Any age
- All patients who develop cGVHD (any grade) by the NIH criteria after allogeneic transplantation
- Written and signed informed consent
Key exclusion criteria (1 listed)
- Absence of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Failure free survival (FFS)
Time frame: 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
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.
8 secondary outcomes
Response rate (RR)
Time frame: 3 and 6 months
Incidence and grade of cGVHD
Time frame: at 1 year from transplant
relapse
Time frame: 1 year from transplant
non-relapse mortality
Time frame: 1 year from transplant
treatment change
Time frame: measured from the start of first-line and subsequent treatment lines for 1 year
Successful withdrawal of immunosuppressive treatment
Time frame: Measured from the start of firs-tline and subsequent treatment lines for 1 year
Overall Survival
Time frame: measured from cGVHD diagnosis until 1 year
Severe Adverse Events (SAE) and Toxicities
Time frame: Measured from first treatment for cGVHD until 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2022.
Related trials for Chronic Graft-Versus-Host Disease
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Natural History Study of Clinical and Biological Factors Determining Outcomes in Chronic Graft-Versus-Host Disease
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Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingPhase 4
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
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Active, not recruitingObservational study
Improving Outcomes Assessment in Chronic GVHD
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Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Attilio Olivieri, MD principal investigator
AOU Ospedali Riuniti di Ancona
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Graft-Versus-Host Disease, run by Gruppo Italiano Trapianto di Midollo Osseo at 27 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure free survival (FFS) (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.