Langerbeins, Petra, Zhang, Can, Robrecht, Sandra, Cramer, Paula, Fuerstenau, Moritz, Al-Sawaf, Othman, von Tresckow, Julia, Fink, Anna-Maria, Kreuzer, Karl-Anton, Vehling-Kaiser, Ursula, Tausch, Eugen, Mueller, Lothar, Eckart, Michael Josef, Schlag, Rudolf, Freier, Werner, Gaska, Tobias, Balser, Christina, Reiser, Marcel, Stauch, Martina, Wendtner, Clemens-Martin, Fischer, Kirsten, Stilgenbauer, Stephan, Eichhorst, Barbara and Hallek, Michael (2021). The CLL12 trial: ibrutinib vs placebo in treatment-naive, early-stage chronic lymphocytic leukemia. Blood, 139 (2). S. 177 - 188. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 1528-0020

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Abstract

Observation is the current standard of care for patients with early-stage asymptomatic chronic lymphocytic leukemia (CLL), as chemotherapy-based interventions have failed to prolong survival. We hypothesized that early intervention with ibrutinib would be well tolerated and lead to superior disease control in a subgroup of early-stage patients with CLL. The phase 3, double-blind, placebo-controlled CLL12 trial randomly assigned asymptomatic, treatment-naive Binet stage A CLL patients at increased risk of progression in a 1:1 ratio to receive ibrutinib (n = 182) or placebo (n = 181) at a dose of 420 mg daily. At a median follow-up of 31 months, the study met its primary endpoint by significantly improv-ing event-free survival in the ibrutinib group (median, not reached vs 47.8 months; hazard ratio = 0.25; 95% confidence interval = 0.14-0.43, P < .0001). Compared with placebo, ibrutinib did not increase overall toxicity, yielding similar incidence and severity of adverse events (AEs). The most common serious AEs were atrial fibrillation, pneumonia, and rash in the ibrutinib group, and basal cell carcinoma, pneumonia, and myocardial infarction in the placebo group. Ibrutinib-associated risk for bleeding (33.5%) was decreased by prohibiting the use of oral anticoagulants through an amendment of the study protocol and by avoiding CYP3A4 drug-drug interactions. Ibrutinib confirms efficacy in CLL patients at an early stage with an increased risk of progression. However, the results do not justify changing the current stan-dard of watch and wait.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhang, CanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robrecht, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fuerstenau, MoritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Al-Sawaf, OthmanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vehling-Kaiser, UrsulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tausch, EugenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, LotharUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eckart, Michael JosefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schlag, RudolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Freier, WernerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaska, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balser, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reiser, MarcelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stauch, MartinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-594677
DOI: 10.1182/blood.2021010845
Journal or Publication Title: Blood
Volume: 139
Number: 2
Page Range: S. 177 - 188
Date: 2021
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 1528-0020
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PROGNOSTIC INDEX; SURVIVAL; GUIDELINES; VENETOCLAX; RITUXIMABMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/59467

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