Classical Hodgkin Lymphoma
Conditions
Brief 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).
Interventions
DRUGBleomycin
DRUGEtoposide
DRUGDoxorubicin
DRUGCyclophosphamide
DRUGVincristine
DRUGProcarbazine
DRUGPrednisone
DRUGBrentuximab Vedotin
DRUGDacarbazine
DRUGDexamethasone
Sponsors
University of Cologne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | 5 years |
| Treatment Related Morbidity | during 6 cycles of chemotherapy (21-day cycles) |
Countries
Germany
Outcome results
None listed