CLL Induction Treatment With Venetoclax and Ibrutinib, Followed by Ibrutinib and Obinutuzumab in Patients With MRD.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

December 29, 2020

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2028

Conditions
CLL
Interventions
DRUG

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.

DRUG

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.

Trial Locations (27)

Unknown

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

All Listed Sponsors
collaborator

Nordic Lymphoma Group

NETWORK

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER