From my study is a phase 3 randomized double-blind placebo study aimed to compare standard treatment which is rituximab CHOP for high-risk diffuse large B-cell lymphoma with a novel treatment with R-CHOP with addition of tafasitamab, an anti-CD19 monoclonal antibody, and lenalidomide. The biological background of the study was to add two agents to standard R-CHOP and lenalidomide is an immunomodulating agent that can increase the NK cells to cooperate with the antibody activity...
From my study is a phase 3 randomized double-blind placebo study aimed to compare standard treatment which is rituximab CHOP for high-risk diffuse large B-cell lymphoma with a novel treatment with R-CHOP with addition of tafasitamab, an anti-CD19 monoclonal antibody, and lenalidomide. The biological background of the study was to add two agents to standard R-CHOP and lenalidomide is an immunomodulating agent that can increase the NK cells to cooperate with the antibody activity. So we randomized all over the world almost 900 patients and only high-risk patients based on international prognostic index high-risk intermediate and high-risk, and also patients with a short time from the diagnosis to start of treatment within 20 days because this recognizes a group of patients with poor prognosis. After three years of follow-up, the study met its primary endpoint about progression-free survival. It was a significant reduction in the risk of progression or deaths for the patients randomized to the experimental arm, with a 25% reduction of risk of progression. And also there was a benefit in terms of event-free survival. A key point that this benefit was observed across all subtypes of diffuse large B-cell lymphoma, in GCB subtypes and also ABC subtypes. And also we observed a benefit for the experimental study for high-risk patients like double-hit lymphoma, even if it’s a small group, but it’s interesting, it’s a good signal to have a new treatment also for these patients.
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