A 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.
- Promotor: Incyte. IP: Norma Gutiérrez. Data manager: Eva Díez.
- Periodo de inclusión:
- Diseño y tratamiento:
- Fase 3. Objetivo principal:
- Fármaco en investigación: tafasitamab + R2.
- Tratamiento experimental: Randomization 1:1 ratio. Treatment period (twelve 28-day cycles).
- Tafasitamab/placebo 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: 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. 30 minutes after the tafasitamab/placebo infusion is completed.Plus
- Lenalidomide : 20 mg PO once daily on Days 1 to 21 of every 28-day cycle for 12 cycles.
- Premedication: Acetaminophen (eg, 650-1000 mg), diphenhydramine hydrochloride (eg, 50-100 mg), and glucocorticosteroids (eg, 100 mg IV prednisone or prednisolone or equivalent) 30 to 60 minutes prior to starting each infusion. Mandatory for the first cycle.
- Prophylaxis of VTE is mandatory for all participants: aspirin 70-325 mg PO daily or low molecular weight heparin.
- Medicación concomitante. Profilaxis antitrombótica.
- Inclusion Criteria:
- Histologically confirmed Grade 1, 2, or 3a FL or histologically confirmed nodal MZL, splenic MZL, or extranodal MZL of the MALT (CD19+ and CD20+ by flow cytometry or immunohistochemistry) as assessed locally.
- At least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy such as rituximab monotherapy or chemotherapy plus immunotherapy with rituximab or obinutuzumab. At least 6 doses of anti-CD20 immunotherapy must have been given in prior therapy (Pending amendment to change to 4)
- Exclusion Criteria:
- Prior use of lenalidomide in combination with rituximab.
- Known CNS lymphoma involvement.
- Known seropositive for HIV. Occult or prior HBV infection (negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable. Antiviral prophylaxis may be administered.
Alejandro Martín García-Sancho (amartingar@usal.es)
Norma Gutiérrez Gutiérrez (normagu@usal.es)
Dolores Caballero Barrigón (cabarri@usal.es)
Hospital Universitario de Salamanca, IBSAL, CIBERONC
