Phase 2 Study of Pembrolizumab and Chemotherapy for Frail Adults with Newly Diagnosed Classical Hodgkin Lymphoma Ineligible for Standard Anthracycline Treatment

What this Trial Is About

Researchers are evaluating how well pembrolizumab combined with chemotherapy drugs gemcitabine, brentuximab vedotin, and dacarbazine works in treating frail patients with newly diagnosed classical Hodgkin lymphoma who cannot receive standard anthracycline-based treatment. This phase II trial explores the use of immunotherapy with pembrolizumab to help the immune system attack cancer cells, alongside chemotherapy agents that target and kill lymphoma cells. The study aims to find effective alternative treatments and assess their safety in this vulnerable patient group. Participants receive treatment in several phases. First, for up to 8 cycles, they get pembrolizumab and gemcitabine intravenously every 21 days. If their disease does not progress, some then receive maintenance therapy with pembrolizumab every 42 days for up to 4 cycles. If the disease progresses, patients move to salvage therapy with pembrolizumab, brentuximab vedotin, and dacarbazine every 21 days for up to 12 cycles. Throughout the study, patients will undergo scans like PETCT and may have heart and lung function tests. During the trial, researchers monitor patients closely, collecting blood samples and assessing physical performance. They measure outcomes such as complete metabolic response, overall response, progression-free survival, duration of response, and overall survival up to 24 months. Safety is also evaluated by tracking adverse events. Follow-up visits occur at 30 days, then at 12, 18 for salvage therapy patients, and 24 months after treatment completion to observe long-term effects and patient health.

Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Standard Treatment