Hodgkin lymphoma
Conditions
Brief summary
Progression free survival probability at 2 years. PFS is defined as time from registration to progression or death from any cause, whichever comes first.
Detailed description
ORR, mCR and mPR rates (as assessed by FDG-PET/CT) after 2 and 4 cycles of tislelizumab in combination with GP chemotherapy induction., Rate of CTCAE grade 3/4 toxicities of tislelizumab in combination with GP chemotherapy., Rate of CTCAE grade 2 to 4 immune related toxicities of tislelizumab in combination with GP chemotherapy., Rate of CTCAE grade 3/4 toxicities of tislelizumab consolidation treatment., PFS as time-to-event outcome., EFS defined as time from registration to start new HL treatment, progression or death from any cause, whichever comes first., DFS defined as time from start of consolidation therapy to relapse or death from any cause, whichever comes first., OS defined as time from registration to death from any cause.
Interventions
DRUGTislelizumab
DRUGGEMCITABINE
DRUGCISPLATIN
DRUGPEGFILGRASTIM
Sponsors
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival probability at 2 years. PFS is defined as time from registration to progression or death from any cause, whichever comes first. | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, mCR and mPR rates (as assessed by FDG-PET/CT) after 2 and 4 cycles of tislelizumab in combination with GP chemotherapy induction., Rate of CTCAE grade 3/4 toxicities of tislelizumab in combination with GP chemotherapy., Rate of CTCAE grade 2 to 4 immune related toxicities of tislelizumab in combination with GP chemotherapy., Rate of CTCAE grade 3/4 toxicities of tislelizumab consolidation treatment., PFS as time-to-event outcome., EFS defined as time from registration to start new HL treatment, progression or death from any cause, whichever comes first., DFS defined as time from start of consolidation therapy to relapse or death from any cause, whichever comes first., OS defined as time from registration to death from any cause. | — |
Countries
Belgium, Denmark, Netherlands
Outcome results
None listed