Publikation: Zeitschriftenartikel

Obinutuzumab (GA-101), ibrutinib, and venetoclax (GIVe) frontline treatment for high-risk chronic lymphocytic leukemia

Grunddaten
Abstract
Autoren
Einrichtung

Grunddaten

Titel	Obinutuzumab (GA-101), ibrutinib, and venetoclax (GIVe) frontline treatment for high-risk chronic lymphocytic leukemia
Erscheinungsjahr	2022
Seiten (von – bis)	1318 – 1329
Band	139
Heft-Nr.	9
Jahr	2022
Publikationsform	Elektronische Ressource
Publikationsart	Zeitschriftenartikel
Sprache	Englisch
DOI	10.1182/blood.2021013208
Letzte Änderung	11.01.2023 06:02:13
Bearbeitungsstatus	durch UB Rostock abschließend validiert
Dauerhafte URL	http://purl.uni-rostock.de/fodb/pub/68912
Links zu Katalogen

Abstract

Despite considerable treatment advances with targeted therapies for patients with chronic lymphocytic leukemia (CLL) deemed high-risk [del(17p) and/or TP53 mutation], the outcome is still inferior compared with other CLL patients. Combining multiple agents with distinct mechanisms of action may further improve outcomes. CLL2-GIVe is an open-label, multicenter trial which enrolled patients with previously untreated CLL with del(17p) and/or TP53 mutation. Patients received induction therapy with obinutuzumab (GA-101), ibrutinib, and venetoclax (GIVe) for cycles 1 through 6 and consolidation therapy with venetoclax and ibrutinib for cycles 7 through 12. Ibrutinib monotherapy was continued for cycles 13 through 36 in patients not reaching a complete response (CR) with serial undetectable minimal residual disease (uMRD) after consolidation. The primary endpoint was CR rate at cycle 15 (final restaging). Secondary endpoints included MRD, survival, and safety. All 41 patients enrolled between September 2016 and August 2018 received study treatment and were included in efficacy and safety populations. With a CR rate of 58.5% at cycle 15, the primary endpoint was met (95% CI: 42.1-73.7; P < .001). At final restaging, 78.0% of patients had uMRD in peripheral blood (PB); 65.9% of patients had uMRD in bone marrow (BM). Estimated progression-free survival (PFS) and overall survival (OS) rates at 24 months were both 95.1%. Adverse events were reported in all patients; most were low grade (grade 3: 23.9%). Two deaths were reported (cardiac failure and ovarian carcinoma), neither related to study treatment. The CLL2-GIVe treatment regimen has a manageable safety profile and is a first-line treatment of good efficacy for patients with high-risk CLL.

Autoren

Huber, Henriette

Edenhofer, Simone

von Tresckow, Julia

Robrecht, Sandra

Zhang, Can

Tausch, Eugen

Schneider, Christof

Bloehdorn, Johannes

Fürstenau, Moritz

Dreger, Peter

Ritgen, Matthias

Illmer, Thomas

Illert, Anna L.

Dürig, Jan

Böttcher, Sebastian

Niemann, Carsten U.

Kneba, Michael

Fink, Anna-Maria

Fischer, Kirsten

Döhner, Hartmut

Hallek, Michael

Eichhorst, Barbara

Stilgenbauer, Stephan

Einrichtung

UMR/ZIM/Klinik III, Hochschulambulanz, Hämatologie und Onkologie