A Prospective, Multicenter, Phase-II Trial of Ibrutinib Plus Venetoclax in Patients With Creatinine Clearance >= 30 ml/Min Who Have Relapsed or Refractory Chronic Lymphocytic Leukemia (RR-CLL) With or Without TP53 Aberrations

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

June 23, 2017

Primary Completion Date

June 30, 2021

Study Completion Date

June 21, 2026

Conditions
Chronic Lymphocytic Leukemia in RelapseChronic Lymphocytic Leukemia in Remission
Interventions
DRUG

Ibrutinib + Venetoclax 15 cycles

"Cycle 1 + 2: 420 mg ibrutinib, day 1-28 \

DRUG

Ibrutinib until progression/relapse

420mg ibrutinib daily until progression/relapse

DRUG

Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles

"Cycle 1: 420 mg ibrutinib \

Trial Locations (49)

Unknown

BE-Antwerpen-ZNASTUIVENBERG, Antwerp

BE-Brugge-AZBRUGGE, Bruges

BE-Bruxelles-STLUC, Brussels

BE-Haine-Saint-Paul-JOLIMONT, Haine-Saint-Paul

BE-Leuven-UZLEUVEN, Leuven

DK-Aalborg-AALBORGUH, Aalborg

DK-Copenhagen-RIGSHOSPITALET, Copenhagen

DK-Herlev-HERLEV, Herlev

DK-Holstebro-HOLSTEBRO, Holstebro

DK-Odense-OUH, Odense

DK-Roskilde-ROSKILDE, Roskilde

FI-Helsinki-HUS, Helsinki

FI-Jyvaskyla-KSSHP, Jyväskylä

FI-Kuopio-KYS, Kuopio

FI-Tampere-TAYS, Tampere

FI-Turku-TYKS, Turku

NL-Alkmaar-NWZ, Alkmaar

NL-Amersfoort-MEANDERMC, Amersfoort

NL-Amsterdam-AMC, Amsterdam

NL-Amsterdam-AVL, Amsterdam

NL-Amsterdam-VUMC, Amsterdam

NL-Arnhem-RIJNSTATE, Arnhem

NL-Breda-AMPHIA, Breda

NL-Delft-RDGG, Delft

NL-Dordrecht-ASZ, Dordrecht

NL-Enschede-MST, Enschede

NL-Gouda-GROENEHART, Gouda

NL-Groningen-UMCG, Groningen

NL-Heerlen-ATRIUMMC, Heerlen

NL-Helmond-ELKERLIEK, Helmond

NL-Nieuwegein-ANTONIUS, Nieuwegein

NL-Nijmegen-CWZ, Nijmegen

NL-Rotterdam-ERASMUSMC, Rotterdam

NL-Rotterdam-MAASSTADZIEKENHUIS, Rotterdam

NL-Sittard-Geleen-ZUYDERLAND, Sittard

NL-Sneek-ANTONIUSSNEEK, Sneek

NL-Den Haag-HAGA, The Hague

NL-Tilburg-ETZ, Tilburg

NL-Uden-BERNHOVEN, Uden

NL-Utrecht-UMCUTRECHT, Utrecht

NL-Zaandam-ZAANSMC, Zaandam

NL-Zwolle-ISALA, Zwolle

NO-Lørenskog-AKERSHUS, Lørenskog

NO-Trondheim-STOLAV, Trondheim

SE-Boras-SASBORAS, Borås

SE-Linköping-REGIONOSTERGOTLAND, Linköping

SE-Luleå-SUNDERBY, Luleå

SE-Lund-SUH, Lund

SE-Uppsala-UPPSALAUH, Uppsala

All Listed Sponsors
collaborator

Nordic CLL Study Group

UNKNOWN

lead

Stichting Hemato-Oncologie voor Volwassenen Nederland

OTHER