Universität zu Köln

Robak, Tadeusz, Hellmann, Andrzej, Kloczko, Janusz, Loscertales, Javier, Lech-Maranda, Ewa ORCID: 0000-0001-9592-0851, Pagel, John M., Mato, Anthony, Byrd, John C., Awan, Farrukh T., Hebart, Holger, Garcia-Marco, Jose A., Hill, Brian T., Hallek, Michael, Eisenfeld, Amy J., Stromatt, Scott C. and Jaeger, Ulrich (2017). Randomized phase 2 study of otlertuzumab and bendamustine versus bendamustine in patients with relapsed chronic lymphocytic leukaemia. Br. J. Haematol., 176 (4). S. 618 - 629. HOBOKEN: WILEY. ISSN 1365-2141

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Abstract

Otlertuzumab (TRU-016) is a humanized anti-CD37 protein therapeutic that triggers direct caspase-independent apoptosis of malignant B cells and induces antibody-dependent cell-mediated cytotoxicity. Patients with relapsed chronic lymphocytic leukaemia (CLL) received either otlertuzumab (20mg/kg) weekly by IV infusion for two 28-day cycles then every 14days for four 28-day cycles and IV bendamustine (70mg/m(2)) on Days 1 and 2 of each cycle for up to six 28-day cycles or bendamustine alone. Thirty-two patients were treated with otlertuzumab and bendamustine and 33 with bendamustine alone. Overall response rate according to the International Workshop on Chronic Lymphocytic Leukaemia criteria was 69% in the otlertuzumab and bendamustine arm and 39% in the bendamustine alone arm (P=0025). Median progression-free survival (PFS) was 159months in the otlertuzumab and bendamustine arm and 102months in the bendamustine alone arm (P=00192). There was a higher incidence of pyrexia (34% vs. 12%) and neutropenia (59% vs. 39%) with the combination but this did not result in a higher incidence of severe (grade 3/4) infections (13% vs. 27%). This combination significantly increased the response rate and prolonged the PFS over single agent bendamustine in patients with relapsed or refractory CLL.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Robak, Tadeusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Hellmann, Andrzej UNSPECIFIED UNSPECIFIED UNSPECIFIED Kloczko, Janusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Loscertales, Javier UNSPECIFIED UNSPECIFIED UNSPECIFIED Lech-Maranda, Ewa UNSPECIFIED orcid.org/0000-0001-9592-0851 UNSPECIFIED Pagel, John M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mato, Anthony UNSPECIFIED UNSPECIFIED UNSPECIFIED Byrd, John C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Awan, Farrukh T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hebart, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Garcia-Marco, Jose A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hill, Brian T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Eisenfeld, Amy J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stromatt, Scott C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Jaeger, Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-240310
DOI:	10.1111/bjh.14464
Journal or Publication Title:	Br. J. Haematol.
Volume:	176
Number:	4
Page Range:	S. 618 - 629
Date:	2017
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1365-2141
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language QUANTITATIVE FLOW-CYTOMETRY; II TRIAL; RITUXIMAB; FLUDARABINE; ANTIBODIES; DIAGNOSIS; PROTEIN; TOLERABILITY; CHLORAMBUCIL; COMBINATION Multiple languages Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/24031