85
Participants
Start Date
December 29, 2020
Primary Completion Date
December 1, 2025
Study Completion Date
December 1, 2028
ibrutinib, venetoclax, obinutuzumab
Patients will receive 3 cycles lead-in with ibrutinib 420 mg/day. Here-after, patients will continue with 13 induction cycles (including one bridging cycle) combining ibrutinib 420 mg/day and venetoclax 400 mg/day (including a ramp up of 5 weeks). Patients who are not in CR or who have detectable MRD after 15 cycles (3 cycles lead-in and 12 cycles induction) will continue with 6 intensification cycles ibrutinib in combination with obinutuzumab day 1, 2, 8, 15 for the first cycle and with obinutuzumab day 1 for the following 5 cycles.
ibrutinib, venetoclax
Patients will receive 3 cycles lead-in with ibrutinib 420 mg/day. Here-after, patients will continue with 13 induction cycles (including one bridging cycle) combining ibrutinib 420 mg/day and venetoclax 400 mg/day (including a ramp up of 5 weeks). Patients who are in CR or have no detectable MRD will be observed.
DK-Aalborg-AALBORGUH, Aalborg
DK-Herlev-HERLEV, Herlev
DK-Odense-OUH, Odense
DK-Roskilde-ROSKILDE, Roskilde
NL-Almere-FLEVOZIEKENHUIS, Almere Stad
NL-Amersfoort-MEANDERMC, Amersfoort
NL-Amsterdam-AMC, Amsterdam
NL-Amsterdam-VUMC, Amsterdam
NL-Dordrecht-ASZ, Dordrecht
NL-Ede-ZGV, Ede
NL-Eindhoven-CATHARINA, Eindhoven
NL-Enschede-MST, Enschede
NL-Gouda-GROENEHART, Gouda
NL-Groningen-UMCG, Groningen
NL-Hilversum-TERGOOI, Hilversum
NL-Hoofddorp-SPAARNEGASTHUIS, Hoofddorp
NL-Roermond-LZR, Roermond
NL-Rotterdam-IKAZIA, Rotterdam
NL-Sittard-Geleen-ZUYDERLAND, Sittard
NL-Sneek-ANTONIUSSNEEK, Sneek
NL-Terneuzen-ZORGSAAM, Terneuzen
NL-Den Haag-HAGA, The Hague
NL-Den Haag-HMCWESTEINDE, The Hague
NL-Tilburg-ETZ, Tilburg
NL-Uden-BERNHOVEN, Uden
NL-Utrecht-UMCUTRECHT, Utrecht
NL-Zwolle-ISALA, Zwolle
Nordic Lymphoma Group
NETWORK
Stichting Hemato-Oncologie voor Volwassenen Nederland
OTHER