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A Prospective Observational Study for Evaluating CGVHD (GITMO-GVCrOSy)

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ClinicalTrials.gov Identifier: NCT02991846
Recruitment Status : Recruiting
First Posted : December 14, 2016
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Trapianto di Midollo Osseo

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.

Condition or disease
Chronic Graft-Versus-Host Disease

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study for Evaluating Incidence, Severity and Outcomes of Chronic Graft-versus-Host Disease According to 2015 NIH Consensus Criteria
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022


Group/Cohort
Patients with cGVHD
All consecutive patients undergoing allogenic stem cell transplant for any underlying disease who develop chronic graft-versus-host disease (cGVHD)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Response rate (RR) [ Time Frame: 3 and 6 months ]
    Global and organ-specific response rate (RR), evaluated 3 and 6 months after starting systemic treatment, by the 2015 NIH criteria

  2. Incidence and grade of cGVHD [ Time Frame: at 1 year from transplant ]
    Incidence and grade of cGVHD, by the 2015 NIH criteria at 1 year after Hematopoietic stem cell transplantation (HSCT)

  3. relapse [ Time Frame: 1 year from transplant ]
    Cumulative incidence of relapse of underlying haematological malignancy

  4. non-relapse mortality [ Time Frame: 1 year from transplant ]
    Cumulative incidence of non-relapse mortality (NRM), defined as any death not due to disease relapse or progression

  5. treatment change [ Time Frame: measured from the start of first-line and subsequent treatment lines for 1 year ]
    Cumulative incidence of treatment change, measured from the start of first-line and subsequent treatment lines

  6. Successful withdrawal of immunosuppressive treatment [ Time Frame: Measured from the start of firs-tline and subsequent treatment lines for 1 year ]
    Cumulative incidence of successful withdrawal of immunosuppressive treatment, measured from the start of first-line and subsequent treatment lines.

  7. Overall Survival [ Time Frame: measured from cGVHD diagnosis until 1 year ]
    Overall Survival, measured from cGVHD diagnosis.

  8. Severe Adverse Events (SAE) and Toxicities [ Time Frame: Measured from first treatment for cGVHD until 1 year ]
    Incidence of Severe Adverse Events (SAE), toxicities (by the Common Terminology Criteria for Adverse Events - CTCAE), infections during treatments.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients undergoing sllogenic stem cell transplant for any underlyng disease who develop chronic graft-versus-host disease (cGVHD)
Criteria

Inclusion Criteria:

  • Any age
  • All patients who develop cGVHD (any grade) by the NIH criteria after allogeneic transplantation
  • Written and signed informed consent

Exclusion Criteria:

  • Absence of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991846


Contacts
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Contact: Attilio Olivieri, MD +390715964226 a.olivieri@univpm.it
Contact: Sonia Mammoliti +390105554423 trialoffice@gitmo.it

Locations
Show Show 53 study locations
Sponsors and Collaborators
Gruppo Italiano Trapianto di Midollo Osseo
Investigators
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Principal Investigator: Attilio Olivieri, MD AOU Ospedali Riuniti di Ancona
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Responsible Party: Gruppo Italiano Trapianto di Midollo Osseo
ClinicalTrials.gov Identifier: NCT02991846    
Other Study ID Numbers: GITMO-GVCrOSy
First Posted: December 14, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Keywords provided by Gruppo Italiano Trapianto di Midollo Osseo:
chronic graft-versus-host disease cGVHD
Hematopoietic stem cell transplantation HSCT
NIH consensus criteria
GITMO
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases