Beschreibung

INCMOR 0208-301 - Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

Studientherapie

Treatment Group A:
· Tafasitamab 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 (every second week) of Cycles 4 to 12. Cycle length 28 days.
Plus
· Rituximab (including biosimilars) 375 mg/m2 IV every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle from Cycle 2 to 5.
Plus
· Lenalidomide (including generics) 20 mg PO once daily on Days 1 to 21 of every 28-day cycle for 12 cycles.
Treatment Group B:
· Tafasitamab placebo (0.9% saline solution) IV on Days 1, 8, 15, and 22 of Cycles 1 to 3 and on Days 1 and 15 (every second week) of Cycles 4 to 12. Cycle length 28 days.
Plus
· Rituximab (including biosimilars) 375 mg/m2 IV every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle from Cycles 2 to 5.
Plus
· Lenalidomide (including generics) 20 mg PO once daily on Days 1 to 21 of every 28-day cycle for 12 cycles.