Universität zu Köln

von Tresckow, Julia, Cramer, Paula, Bahlo, Jasmin, Robrecht, Sandra, Langerbeins, Petra, Fink, Anna-Maria, Al-Sawaf, Othman, Illmer, Thomas, Klaproth, Holger, Estenfelder, Sven, Ritgen, Matthias, Fischer, Kirsten, Wendtner, Clemens-Martin, Kreuzer, Karl-Anton, Stilgenbauer, Stephan, Boettcher, Sebastian, Eichhorst, Barbara F. and Hallek, Michael (2019). CLL2-BIG: sequential treatment with bendamustine, ibrutinib and obinutuzumab (GA101) in chronic lymphocytic leukemia. Leukemia, 33 (5). S. 1161 - 1173. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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Abstract

Obinutuzumab (GA101) and ibrutinib show excellent efficacy for treatment of chronic lymphocytic leukemia (CLL). Preclinical investigations and a complementary safety profile were in support of testing their combined use. The exploratory CLL2-BIG-trial evaluated a sequential combination therapy following a recently proposed strategy. Two courses of bendamustine were used for debulking in patients with a high tumor load, followed by six courses of induction therapy with ibrutinib and GA101, followed by an MRD-triggered maintenance phase. The results of a pre-planned analysis at the end of the induction phase are presented. 61 patients were included, 30 previously untreated and 31 with relapsed/refractory CLL. 44 patients received bendamustine. During induction, neutropenia (14.8%) and thrombocytopenia (13.1%) were the most common CTC grade 3 and 4 events. One fatality (duodenitis) occurred. The overall response rate was 100%. 54.1% of patients achieved a partial remission, 41% a clinical complete remission (cCR) without confirmation by CT scan or bone marrow (BM) biopsy according to protocol and 4.9% a cCR with incomplete recovery of the BM. 29 patients (47.5%) had no detectable (<10(-4)) minimal residual disease assessed by flow cytometry in peripheral blood. In conclusion, the BIG regimen is a safe and highly effective therapy for CLL.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code von Tresckow, Julia UNSPECIFIED UNSPECIFIED UNSPECIFIED Cramer, Paula UNSPECIFIED UNSPECIFIED UNSPECIFIED Bahlo, Jasmin UNSPECIFIED UNSPECIFIED UNSPECIFIED Robrecht, Sandra UNSPECIFIED UNSPECIFIED UNSPECIFIED Langerbeins, Petra UNSPECIFIED UNSPECIFIED UNSPECIFIED Fink, Anna-Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Al-Sawaf, Othman UNSPECIFIED UNSPECIFIED UNSPECIFIED Illmer, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Klaproth, Holger UNSPECIFIED UNSPECIFIED UNSPECIFIED Estenfelder, Sven UNSPECIFIED UNSPECIFIED UNSPECIFIED Ritgen, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED Wendtner, Clemens-Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Kreuzer, Karl-Anton UNSPECIFIED UNSPECIFIED UNSPECIFIED Stilgenbauer, Stephan UNSPECIFIED UNSPECIFIED UNSPECIFIED Boettcher, Sebastian UNSPECIFIED UNSPECIFIED UNSPECIFIED Eichhorst, Barbara F. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-149949
DOI:	10.1038/s41375-018-0313-8
Journal or Publication Title:	Leukemia
Volume:	33
Number:	5
Page Range:	S. 1161 - 1173
Date:	2019
Publisher:	NATURE PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	1476-5551
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PREVIOUSLY UNTREATED PATIENTS; MINIMAL RESIDUAL DISEASE; PHASE-II TRIAL; 1ST-LINE TREATMENT; PLUS CHLORAMBUCIL; RITUXIMAB; CLL; CHEMOIMMUNOTHERAPY Multiple languages Oncology; Hematology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/14994