So already, there is a US intergroup study led by the Children’s Oncology Group that follows very nicely from our non-randomized Phase II study. And in this trial, patients are stratified according to favorable or unfavorable according to the EORTC criteria, and then receive or are PET stratified. So the PET-2 negative patients are randomized to standard of care...
So already, there is a US intergroup study led by the Children’s Oncology Group that follows very nicely from our non-randomized Phase II study. And in this trial, patients are stratified according to favorable or unfavorable according to the EORTC criteria, and then receive or are PET stratified. So the PET-2 negative patients are randomized to standard of care. They would get four total cycles of ABVD. The patients who are on the experimental arm start with two cycles of ABVD. And if they’re negative, then they get four cycles of rituximab plus nivolumab. In the PET-positive patients, after two cycles of ABVD, they get standard of care with escalated BEACOPP and radiation versus BV-Nivo plus radiation. Similar design for the unfavorable, though in the standard arm PET negative, they get six total cycles of chemotherapy. So I think this is a really important study and it’s randomized and it will really tell us, you know, do we need to incorporate these therapies? The thing about early stage Hodgkin lymphoma is the majority of patients do very well with chemotherapy or combined modality therapy. So we really have to make sure that we’re not causing excess toxicity by adding in these agents. We need to do quality of life assessments. And we will be collecting samples to look at circulating tumor DNA because I think this is, again, where the field is heading. You know, really being able to identify those patients who become negative early and then significantly peel back on the amount of treatment they need. So I think we’re going to, it’s a very large study, 1,875 planned patients. So it’s really going to be an amazing result and data that’s going to shape the field moving forward.
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