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Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial.

Authors :
Liberati A.M.
Fogliatto L.M.
Niemann C.U.
Weinkove R.
Robinson S.
Kipps T.J.
Tausch E.
Schary W.
Ritgen M.
Wendtner C.-M.
Kreuzer K.-A.
Eichhorst B.
Stilgenbauer S.
Hallek M.
Fischer K.
Le Du K.
Pinilla-Ibarz J.
Zhang C.
Tandon M.
Sinha A.
Fink A.-M.
Robrecht S.
Samoylova O.
Sivcheva L.
Opat S.
Al-Sawaf O.
Liberati A.M.
Fogliatto L.M.
Niemann C.U.
Weinkove R.
Robinson S.
Kipps T.J.
Tausch E.
Schary W.
Ritgen M.
Wendtner C.-M.
Kreuzer K.-A.
Eichhorst B.
Stilgenbauer S.
Hallek M.
Fischer K.
Le Du K.
Pinilla-Ibarz J.
Zhang C.
Tandon M.
Sinha A.
Fink A.-M.
Robrecht S.
Samoylova O.
Sivcheva L.
Opat S.
Al-Sawaf O.
Publication Year :
2020

Abstract

Background: Venetoclax plus obinutuzumab has been established as a fixed-duration treatment regimen for patients with chronic lymphocytic leukaemia. We compared the long-term efficacy after treatment cessation of the combination of venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia. Method(s): CLL14 is a multicentre, randomised, open-label, phase 3 trial done at 196 sites in 21 countries. Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30-69 mL/min, or both. Patients were randomly assigned (1:1) via a web and voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region. Patients received either venetoclax plus obinutuzumab (oral venetoclax initiated on day 22 of cycle 1 [28-day cycles], with a 5-week dose ramp-up [20 mg, 50 mg, 100 mg, and 200 mg, then 400 mg daily for 1 week], thereafter continuing at 400 mg daily until completion of cycle 12; combined with intravenous obinutuzumab for six cycles starting with 100 mg on day 1 and 900 mg on day 2 [or 1000 mg on day 1], 1000 mg on days 8 and day 15 of cycle 1, and subsequently 1000 mg on day 1 of cycles 2 through 6) or chlorambucil plus obinutuzumab (oral chlorambucil at 0.5 mg/kg bodyweight on days 1 and 15 of each cycle for 12 cycles combined with the same obinutuzumab regimen). The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. Patient enrolment is complete, and the study is registered with ClinicalTrails.gov, NCT02242942. Finding(s): Between Aug 7, 2015, and Aug 4, 2016, 432 patients were enrolled and randomly assigned to

Details

Database :
OAIster
Publication Type :
Electronic Resource
Accession number :
edsoai.on1305125742
Document Type :
Electronic Resource