Observational studyBone marrow transplantation2026
Early software-assisted response predicts survival in a prospective cohort of 258 newly diagnosed cGvHD patients.
Observational study in Bone marrow transplantation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02991846 (A Prospective Observational Study for Evaluating Incidence, Severity and Outcomes of Chronic Graft-versus-Host Disease According to 2015 NIH Consensus Criteria), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Observational Study for Evaluating Incidence, Severity and Outcomes of Chronic Graft-versus-Host Disease According to 2015 NIH Consensus Criteria
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Corrections and comments
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Authors and funding
34 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Two hundred and fifty-eight patients with newly diagnosed cGVHD have been enrolled in a multicenter study (NCT02991846). Primary endpoint was failure free survival (FFS); secondary endpoints were ORR at 6 and 12 months after best available therapy (BAT) and OS. Response evaluation was supported by a software (Crosy) collecting cGvHD master data. Software-assisted (SA) response and clinician-based (CB) evaluation, according to NIH criteria, have been performed in parallel at 6 and 12 months. Among 258 patients, 200 needed systemic therapy (ST); 167 were evaluable for response; ORR according to SA was 62% (CR:19%; PR: 43%), and 65% (CR: 23%; PR: 42%) according to the CB evaluation; overall agreement was 66%. In multivariate analysis, only 6-month SA response significantly predicted OS, being more effective in capturing Mixed Responses, compared to CB evaluation. After 12 months 23% of patients were able to stop ST: significantly more patients who maintained ST1 stopped ST (39%) than those who requested a ST1 change (9,5%); (p < 0.001). The 2-year FFS of patients receiving ST was 67%; 2-year OS was 85%: 32 patients (18%) died (30 due to cGVHD progression or causes coexisting with cGvHD). SA evaluation of response in cGVHD is reliable and predicts FFS.
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