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EBMT 2018 | The NIH Chronic GvHD Consensus Response Criteria for clinical trials

In this video, Steven Pavletic, MD, MS, from the National Cancer Institute, Bethesda, MD, speaks about measuring organ and overall responses in patients with chronic graft-versus-host disease (GvHD), using the NIH Consensus Response Criteria. Dr Pavletic was speaking at the European Society for Blood and Marrow Transplantation (EBMT) 2018 Annual Meeting, held in Lisbon, Portugal

Transcript (edited for clarity)

I’m going back to this because when those criteria were developed, our investigators who worked on that took lots of heat from the field like, you’re creating something that’s very complicated, we had to do that and it’s not that complicated, but now we have a tool that is reproducible, they can serve for clinical trials, a regulatory pathway approval. So those criteria are very stringent, so 68% using image criteria, it’s probably much higher if you use the old investigator driven criteria...

I’m going back to this because when those criteria were developed, our investigators who worked on that took lots of heat from the field like, you’re creating something that’s very complicated, we had to do that and it’s not that complicated, but now we have a tool that is reproducible, they can serve for clinical trials, a regulatory pathway approval. So those criteria are very stringent, so 68% using image criteria, it’s probably much higher if you use the old investigator driven criteria.
Second, toxicity profile was acceptable, it was not negligible, about one third of patients had to stop treatment because of side effects, side effects were not surprising. They are what is usually seen with ibrutinib, but some patients had to stop the drug.
Then third, there was a quite high proportion of responders that were able to stay on maintained response beyond six months. Well, it’s another very important aspect, that responses were not all the responses, but they were durable. High proportion of patients as well were able to taper corticosteroids, and then using secondary endpoints, the symptom scale will tell us how much patients are suffering from symptoms of chronic graph versus host disease, those signals as well approved.
All this led to this trial, that we think is historical because it was for so many years our goal to have a first drug ever approved, but this is really what we now expect, signalling and opening the gate to come in with the new trials, bigger trials, different drugs, new drug combinations, they can really exert authentic and even more improved benefit in this patient population.

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