AHOD2131: A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Brief description of study

This study is about patients who have recently been diagnosed with early-stage classical Hodgkin lymphoma (cHL). The researchers want to compare two treatment approaches: one uses a targeted drug called Brentuximab Vedotin (Bv) together with a PD-1 blocker called Nivolumab, and the other uses a standard chemotherapy treatment with or without radiation therapy. The main aim is to see how long it takes for the cancer to get worse (progression-free survival) in patients who get the standard treatment compared to those who get the targeted treatment. Patients will be chosen randomly to receive either the standard chemotherapy or the targeted treatment based on the results of a PET/CT scan after they've had two rounds of ABVD (chemotherapy treatment which uses the four drugs Doxorubicin, Bleomycin, Vinblastine and Dacarbazine) chemotherapy. The patients will be divided into groups based on how risky their disease is, and those who test positive on the PET/CT scan will also get radiation therapy. Along with measuring the progression-free survival, the study will also look at how the targeted treatment affects the patients in the short term and long term. This includes looking at any side effects they have, how their overall quality of life is, and how long they survive for up to 12 years.

Clinical Study Identifier: s23-00586
ClinicalTrials.gov Identifier: NCT05675410
Principal Investigator: Chana Glasser.

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