NCT02661503

HD21 for Advanced Stages

HD21 for Advanced Stages Treatment Optimization Trial in the First-line Treatment of Advanced Stage Hodgkin Lymphoma; Comparison of 6 Cycles of Escalated BEACOPP With 6 Cycles of BrECADD

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Primary objective of the trial is to demonstrate non-inferior efficacy of six cycles of BrECADD compared to six cycles of escalated BEACOPP, each followed by radiotherapy to PET-positive residual lesions ≥2.5 cm, in terms of progression free survival (efficacy objective). If non-inferior efficacy can be shown, the co-primary objective is to further demonstrate reduced toxicity of the BrECADD treatment compared to the escalated BEACOPP treatment measured by treatment related morbidity (TRMorbidity objective).

Conditions

• Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Bleomycin
DRUG	Etoposide
DRUG	Doxorubicin
DRUG	Cyclophosphamide
DRUG	Vincristine
DRUG	Procarbazine
DRUG	Prednisone
DRUG	Brentuximab Vedotin
DRUG	Dacarbazine
DRUG	Dexamethasone

Timeline

• Start date: 2016-07-01
• Primary completion: 2022-12-01
• Completion: 2025-09-01
• First posted: 2016-01-22
• Last updated: 2024-05-13

Locations

1 site across 1 country: Germany