HD21 for Advanced Stages

• Status: Recruiting
• Trial end date: 2025-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Antibodies, Monoclonal; BB 1101; Bleomycin; Brentuximab Vedotin; Cyclophosphamide; Dacarbazine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Etoposide; Etoposide phosphate; Prednisone; Procarbazine; Vincristine

Criteria

Inclusion Criteria:

• Histologically proven classical Hodgkin lymphoma

• First diagnosis, no previous treatment, 18 to 60 years of age

• Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV

Exclusion Criteria:

• Composite lymphoma or nodular lymphocyte-predominant Hodgkin lymphoma

• Previous malignancy (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)

• Prior chemotherapy or radiotherapy