Advanced stage Hodgkin Lymphoma
Conditions
Brief summary
Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient). The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause.
Detailed description
FDG-PET result (positive/negative) after 1 cycle of BrAVD (central assessment), Response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT, Progression-free survival (where progression, relapse and death from any cause are considered events), Overall survival, Safety and tolerability, Response according to RECIL 2017
Interventions
DRUGDACARBAZINE
DRUGDOXORUBICIN
DRUGDEXAMETHASONE
DRUGVINBLASTINE
DRUGCYCLOPHOSPHAMIDE
DRUGETOPOSIDE
Sponsors
European Organisation For Research And Treatment Of Cancer
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Modified progression-free survival rate at 2 years after start of treatment (2yr-mPFS for each patient). The following are considered events for the primary endpoint: progression/relapse; start of new treatment for cHL when not in CR after completing protocol treatment; death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| FDG-PET result (positive/negative) after 1 cycle of BrAVD (central assessment), Response according to Lugano Criteria at end of protocol treatment i.e. after chemotherapy and after radiotherapy (if administered), as defined by FDG-PET/CT, Progression-free survival (where progression, relapse and death from any cause are considered events), Overall survival, Safety and tolerability, Response according to RECIL 2017 | — |
Countries
Belgium, Denmark, Netherlands, Poland, Portugal, Slovakia, Spain
Outcome results
None listed