AHOD2131: A Randomized Phase 3 Response-Adapted Trial Comparing Standard Therapy to Immuno-oncology for Children & Adults with Newly Diagnosed Stage I and II Hodgkin Lymphoma
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Introduction Chemotherapy with or without radiotherapy (RT) is a standard frontline treatment for early-stage (ES) classic Hodgkin lymphoma (cHL). Toxicities due to conventional chemotherapy and RT are of concern, as incidence of cHL peaks in adolescents and young adults. Novel immunotherapy (IO) agents offer new potential frontline therapies in ES cHL that aim to improve progression-free survival (PFS) and maintain overall survival (OS), while minimizing morbidity and late effects. Methods AHOD2131 was developed collaboratively between pediatric and medical oncologists in the National Cancer Institute’s National Clinical Trial Network (NCTN) groups, aiming to harmonize IO-based treatment approaches for ES cHL. Study champions from North American (NA) cooperative groups [COG, SWOG, ECOG-ACRIN, Alliance, NRG] and experts in imaging, radiation oncology, lymphoma biology and patient-reported outcomes (PRO) were included. The resulting COG-led trial represents the largest ES cHL trial in the history of NA cooperative groups and the first to enroll patients across the age continuum. Results AHOD2131 (NCT05675410) is a randomized, phase 3 trial for patients ages 5 to 60 years with newly diagnosed stage I/II cHL, comparing the addition of brentuximab vedotin (Bv) with nivolumab to standard chemotherapy+/- involved site RT (ISRT). AHOD2131 was activated in April 2023 with a target enrollment of 1875 patients over 5 years. As of 28 May 2025, 336 sites have activated and 503 participants have enrolled. 241 (49%) patients are< 18 years of age. The primary objective is to compare PFS through a response-adapted, superiority design with either standard therapy or IO (Bv+nivolumab). Enrollment is stratified based on favorable or unfavorable risk features at registration. Based on response assessment by PET/CT (central review) after 2 cycles of ABVD, patients will be designated PET2 positive (slow early response [SER]) or PET2 negative (rapid early response [RER]). Patients with SER receive systemic therapy and ISRT while those with RER receive systemic therapy only. Key secondary endpoints include a non-inferiority comparison of 12-year OS and longitudinal PRO measures assessing health related quality of life, with 11 additional secondary endpoints and 10 exploratory aims. Conclusion AHOD2131 aims to evaluate an IO approach and establish a harmonized standard of care for ES cHL across the age continuum in the NCTN. Publication History Article published online: 02 December 2025 © 2025. Thieme. All rights reserved. Georg Thieme Verlag KG Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- AHOD2131: A Randomized Phase 3 Response-Adapted Trial Comparing Standard Therapy to Immuno-oncology for Children & Adults with Newly Diagnosed Stage I and II Hodgkin Lymphoma
- Date Crossref
- 01/12/2025
- Éditeur
- Georg Thieme Verlag KG
- Type
- proceedings-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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s Hospital London Health Sciences Centre — Western University, London Health Sciences Centre et Children's Hospital of Western Ontario, avec 9 autres affiliations.
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