New Phase 3 Clinical Trial Opens for Pediatric, Adult Hodgkin Lymphoma Patients

While an estimated 95% of “younger” patients diagnosed with Hodgkin lymphoma are still alive and into survivorship within five years of their diagnosis, their long-term health suffers from the aggressive treatment needed to fight the disease.

November 10, 2025

Roswell Park Comprehensive Cancer Center

Overview

A new Phase 3 clinical trial (AHOD2131) is evaluating whether adding immunotherapy can reduce the intensity and long-term toxicities of conventional chemotherapy and radiation in pediatric and adult patients with stage 1 or 2 Hodgkin lymphoma. The trial aims to maintain high survival rates while minimizing treatment-related complications.

Background

Hodgkin lymphoma has excellent short-term survival, with over 95% of younger patients alive at five years post-diagnosis. However, aggressive treatments often cause severe long-term complications such as secondary cancers and cardiovascular disease, increasing mortality over decades. Current therapies include chemotherapy regimens like ABVD and radiation, both contributing to toxicity. There is a critical need to develop treatment protocols that reduce these risks without compromising efficacy.

Data Highlights

Trial Feature	Details
Patient Population	Stage 1 or 2 Hodgkin lymphoma, ages 5-60
Trial Type	Phase 3, randomized
Standard Arm	ABVD chemotherapy cycles based on risk and response
Experimental Arm	4 cycles brentuximab vedotin + nivolumab immunotherapy
Radiation Therapy	Involved site RT for ~15% with slow early response
Accrual Goal	1,875 patients over 5 years
Sites	300+ including Roswell Park

Key Findings

Long-term mortality in Hodgkin lymphoma survivors is increased due to treatment-related toxicities.
AHOD2131 trial incorporates immunotherapy (brentuximab vedotin + nivolumab) to reduce chemotherapy and radiation exposure.
Patients start with 2 cycles of ABVD, then PET CT determines rapid vs slow responders for treatment randomization.
Only about 15% of patients are expected to require radiation therapy, a significant reduction from historical rates.
The trial includes correlative studies using PET volumetrics and AI to better assess treatment response.
Patient-reported outcomes are collected to evaluate regimen tolerability.

Clinical Implications

This trial may establish a new standard of care by reducing exposure to toxic chemotherapy agents and radiation, potentially lowering the incidence of long-term complications in early-stage Hodgkin lymphoma patients. Clinicians should consider referring eligible patients aged 5 to 60 for enrollment to access this promising immunotherapy-based approach. Monitoring response with advanced imaging and patient-reported outcomes will enhance personalized treatment decisions.

Conclusion

The AHOD2131 trial represents a significant effort to improve long-term survivorship in Hodgkin lymphoma by integrating immunotherapy to minimize treatment toxicity while maintaining excellent cure rates. Its large scale and collaborative design offer hope for safer, more effective therapies.