Hodgkin Lymphoma
Conditions
Brief summary
The Purpose of this trial is: * to determine complete response rate (CRR) after six cycles of chemotherapy * to determine complete remission rate (CR/CRr) as final treatment outcome after completion of treatment
Interventions
DRUGEtoposide
DRUGCyclophosphamide
DRUGDoxorubicin
DRUGPrednisone
DRUGProcarbazine
DRUGDexamethasone
DRUGDacarbazine
DRUGBrentuximab Vedotin
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, age: 18-60 years * Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease
Exclusion criteria
* Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL) * Previous malignancy * Prior chemotherapy or radiation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate (RR) after six cycles of chemotherapy | 18 weeks |
| Complete remission rate (CR/CRr) as final treatment outcome after completion of treatment | 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate | 2 years |
| Progression Free Survival (PFS) | 2 years |
| Relative dose intensity | 18 weeks |
| Dose reduction rate | 18 weeks |
| Overall survival (OS) | 2 years |
Countries
Germany
Outcome results
None listed