A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti-CD19 Monoclonal Antibody Tafasitamab and the PI3K Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia (topMIND).
- Promotor: Incyte. IP: Norma Gutiérrez. Data manager: Manuel Delgado.
- Periodo de inclusión: 100 pacientes en 5 cohortes.
- Diseño y tratamiento:
- Fase 1b/2a. Objetivo principal: Tasa de respuestas (fase 2).
- Fármaco en investigación: tafasitamab + parsaclisib (inh PI3K).
- Tratamiento experimental: Ciclos de 28 días hasta progresión. Tafasitamab will be administered at 12 mg/kg IV on Days 1, 8, 15, and 22 of Cycles 1 through 3 and then Days 1 and 15 of each 28-day cycle from Cycle 4 onward. Parsaclisib will be self-administered at a dose of 20 mg QD for 8 weeks, followed by a dose of 2.5 mg QD thereafter.
- Medicación concomitante. Profilaxis de PJ y CMV.
- Población. R/R DLBCL, R/R MCL, R/R FL, R/R MZL, or R/R CLL/SLL. Participants must have been adequately pretreated and have failed to respond to at least 2 prior lines of systemic antilymphoma/antileukemia therapy. Exclusión si tratamiento anti-CD19 previo (incluido CAR).
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
