55
Participants
Start Date
September 5, 2025
Primary Completion Date
June 15, 2027
Study Completion Date
December 15, 2028
Acalabrutinib + R-CHOP standard of care
Acalabrutinib will be administered 100 mg twice per day (BID) orally (PO) until disease progression if medically appropriate, along with R-CHOP standard of care up to six 21-day cycles of the induction phase.
Acalabrutinib combination with Rituximab
If the subject achieves response during the induction phase, acalabrutinib will be administered 100 mg BID PO until disease progression and rituximab 375 mg/m2 on Day 1 of every other 28-day cycle for a maximum of 12 additional doses.
Acalabrutinib monotherapy
If the subject does not achive response during the induction phase, monotherapy acalabrutinib will be administered 100 mg BID PO until disease progression.
RECRUITING
Research Site, A Coruña
RECRUITING
Research Site, Donostia / San Sebastian
RECRUITING
Research Site, Madrid
NOT_YET_RECRUITING
Research Site, Madrid
RECRUITING
Research Site, Madrid
NOT_YET_RECRUITING
Research Site, Madrid
WITHDRAWN
Research Site, Majadahonda
RECRUITING
Research Site, Alcorcón
NOT_YET_RECRUITING
Research Site, Málaga
RECRUITING
Research Site, Gijón
NOT_YET_RECRUITING
Research Site, Vigo
NOT_YET_RECRUITING
Research Site, Salamanca
RECRUITING
Research Site, Santa Cruz de Tenerife
NOT_YET_RECRUITING
Research Site, Santander
RECRUITING
Research Site, Seville
RECRUITING
Research Site, Valencia
RECRUITING
Research Site, Valencia
RECRUITING
Research Site, Badalona
RECRUITING
Research Site, Barcelona
NOT_YET_RECRUITING
Research Site, Barcelona
RECRUITING
Research Site, Burgos
RECRUITING
Research Site, Palma de Mallorca
Lead Sponsor
Apices Soluciones S.L.
INDUSTRY
AstraZeneca
INDUSTRY