follicular lymphoma (FL) and marginal zone lymphoma (MZL)
Conditions
Brief summary
PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014). PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
Detailed description
* PFS by INV assessment in the overall population (FL and MZL populations). * PET-CR rate by INV in the FDG-avid FL population, defined as a complete metabolic response at any time after start of treatment. *OS in the FL population.
Interventions
DRUGRevlimid 10 mg hard capsules
DRUG0.9% saline solution for infusion. The placebo (250 mL infusion container with 0.9% (w/v) sodium chloride for injection) is being sourced locally from commercial market and delivered to an unblinded pharmacy.
DRUGRevlimid 5 mg hard capsules
DRUGRevlimid 15 mg hard capsules
Sponsors
Incyte Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS by investigator (INV) assessment in the FL population, using Lugano 2014 criteria (Cheson et al 2014). PFS is defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| * PFS by INV assessment in the overall population (FL and MZL populations). * PET-CR rate by INV in the FDG-avid FL population, defined as a complete metabolic response at any time after start of treatment. *OS in the FL population. | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden
Outcome results
None listed