Cramer, Paula, von Tresckow, Julia, Robrecht, Sandra, Bahlo, Jasmin, Furstenau, Moritz ORCID: 0000-0002-6593-0140, Langerbeins, Petra, Pflug, Natali, Al-Sawaf, Othman ORCID: 0000-0001-9895-0570, Heinz, Werner J., Vehling-Kaiser, Ursula, Durig, Jan, Tausch, Eugen, Hensel, Manfred, Sasse, Stephanie, Fink, Anna-Maria, Fischer, Kirsten, Kreuzer, Karl-Anton, Boettcher, Sebastian, Ritgen, Matthias, Kneba, Michael, Wendtner, Clemens-Martin, Stilgenbauer, Stephan, Eichhorst, Barbara and Hallek, Michael (2021). Bendamustine followed by ofatumumab and ibrutinib in chronic lymphocytic leukemia: primary endpoint analysis of a multicenter, open-label, phase II trial (CLL2-BIO). Haematologica, 106 (2). S. 543 - 555. PAVIA: FERRATA STORTI FOUNDATION. ISSN 0390-6078

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Abstract

The introduction of targeted agents has revolutionized the treatment of chronic lymphocytic leukemia but only few patients achieve a complete remission and minimal residual disease negativity with ibrutinib monotherapy. This multicenter, investigator-initiated, phase II study is evaluating sequential treatment with two cycles of bendamustine debulking for patients with a higher tumor load, followed by ofatumumab and ibrutinib induction and maintenance treatment. An all-comer population, irrespective of prior treatment, physical fitness and genetic factors, was included. The primary endpoint was the investigator-assessed overall response rate at the end of induction treatment. Of 66 patients enrolled, one patient with early treatment discontinuation was excluded from the efficacy analysis as predefined by the protocol. Thirty-nine patients (60%) were treatment-naive and 26 patients (40%) had relapsed/refractory chronic lymphocytic leukemia, 21 patients (32%) had a del(17p) and/or TP53 mutation and 45 patients (69%) had unmutated IGHV status. At the end of the induction, 60 of 65 patients (92%) responded and nine (14%) achieved minimal residual disease negativity (<10(-4)) in peripheral blood. No unexpected or cumulative toxicities occurred. The most common grade 3 or 4 adverse events, according to the Common Toxicity Criteria, were neutropenia, anemia, infusion-related reactions, and diarrhea. This sequential treatment of bendamustine debulking, followed by ofatumumab and ibrutinib was well tolerated without unexpected safety signals and showed a good efficacy with an overall response rate of 92%. Ongoing maintenance treatment aims at deeper responses with minimal residual disease negativity. However, ibrutinib should still be used as a single agent outside clinical trials.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Cramer, PaulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
von Tresckow, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Robrecht, SandraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bahlo, JasminUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Furstenau, MoritzUNSPECIFIEDorcid.org/0000-0002-6593-0140UNSPECIFIED
Langerbeins, PetraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pflug, NataliUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Al-Sawaf, OthmanUNSPECIFIEDorcid.org/0000-0001-9895-0570UNSPECIFIED
Heinz, Werner J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vehling-Kaiser, UrsulaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Durig, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tausch, EugenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hensel, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sasse, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fink, Anna-MariaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, KirstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boettcher, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ritgen, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kneba, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wendtner, Clemens-MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stilgenbauer, StephanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eichhorst, BarbaraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hallek, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-598046
DOI: 10.3324/haematol.2019.223693
Journal or Publication Title: Haematologica
Volume: 106
Number: 2
Page Range: S. 543 - 555
Date: 2021
Publisher: FERRATA STORTI FOUNDATION
Place of Publication: PAVIA
ISSN: 0390-6078
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
MINIMAL RESIDUAL DISEASE; INITIAL THERAPY; RITUXIMAB; CHEMOIMMUNOTHERAPY; CYCLOPHOSPHAMIDE; FLUDARABINE; VENETOCLAX; RESISTANCE; BTK; OUTCOMESMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/59804

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