title: A phase 2, multicenter study investigating ofatumumab and bendamustine combination in patients with untreated or relapsed CLL.
abstract: The purpose of this study is to assess the safety and efficacy of the combination of ofatumumab and bendamustine in patients with previously untreated or relapsed chronic lymphocytic leukemia. Patients received IV ofatumumab (cycle 1: 300 mg day 1 and 1,000 mg day 8; cycles 2-6: 1,000 mg on day 1 every 28 days) and IV bendamustine 90 mg m(-2) (previously untreated) or 70 mg m(-2) (relapsed) on days 1 and 2 of each 28-day cycle, for up to 6 cycles. Forty-four previously untreated and 53 relapsed patients were enrolled. Median age was 62.5 years (previously untreated) and 68 years (relapsed); relapsed patients had received a median of 1 (range 1-11) prior therapy. The investigator-assessed overall response rate was 95% (43% complete response [CR]) for the previously untreated, and 74% (11% CR) for the relapsed patients. The regimen was well tolerated with 89% (previously untreated) and 85% (relapsed patients) receiving all 6 cycles. No unexpected toxicities were reported. Grade 3/4 events occurred in 57% of previously untreated, and 72% of relapsed patients. At ∼29 months' follow-up, the median progression-free survival (PFS) was not reached for the previously untreated population, and the 28-month PFS estimate was 72.3%. The median PFS for the relapsed population was 22.5 months (95% CI: 14.0-27.3 months). The combination of ofatumumab and bendamustine was well tolerated and effective in these previously untreated or relapsed populations. Am. J. Hematol. 91:900-906, 2016. © 2016 Wiley Periodicals, Inc.
authors.affiliation: Sarah Cannon Research Institute, Tennessee.
authors.forename: Ian W
authors.initials: IW
authors.lastname: Flinn
authors.affiliation: Department of Propaedeutic Internal Medicine, Laiko Hospital, University of Athens, Athens, Greece.
authors.forename: Panayiotis
authors.initials: P
authors.lastname: Panayiotidis
authors.affiliation: Raisa Gorbacheva Memorial Institute of Children Oncology, Hematology and Transplantation, Pavlov State Medical University, St. Petersburg, Russian Federation.
authors.forename: Boris
authors.initials: B
authors.lastname: Afanasyev
authors.affiliation: Department of Development and Regeneration, Universitair Ziekenhuizen Leuven, Leuven, Belgium.
authors.forename: Ann
authors.initials: A
authors.lastname: Janssens
authors.affiliation: Department of Cancer Prevention, School of Public Health, Silesian Medial University, Katowice, Poland.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Grosicki
authors.affiliation: Department of Hematology, Institute of Health Sciences Pomeranian Academy, Slupsk, Poland.
authors.forename: Wojciech
authors.initials: W
authors.lastname: Homenda
authors.affiliation: Department of Internal Medicine - Hematology, Faculty of Medicine in Hradec Kralove, University Hospital and Charles University in Prague, Hradec Kralove, Czech Republic.
authors.forename: Lukas
authors.initials: L
authors.lastname: Smolej
authors.affiliation: Department and Clinic of Haematology, Blood Neoplasms, and Bone Marrow Transplantation, Akademia Medyczna We Wroclawiu, Wroclaw, Poland.
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Kuliczkowski
authors.affiliation: Department of Internal Medicine - Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.
authors.forename: Michael
authors.initials: M
authors.lastname: Doubek
authors.affiliation: Department of Hematology, Novosibirsk State Regional Clinical Hospital, Novosibirsk, Russian Federation.
authors.forename: Natalia
authors.initials: N
authors.lastname: Domnikova
authors.affiliation: Global Clinical Development, Novartis, Uxbridge, United Kingdom.
authors.forename: Sarah L
authors.initials: SL
authors.lastname: West
authors.affiliation: Statistics, Novartis, Research Triangle Park, North Carolina.
authors.forename: Chai-Ni
authors.initials: CN
authors.lastname: Chang
authors.affiliation: Global Clinical Development, Novartis, Uxbridge, United Kingdom.
authors.forename: Alison M
authors.initials: AM
authors.lastname: Barker
authors.affiliation: Global Clinical Development, Novartis, King of Prussia, Pennnsylvania.
authors.forename: Ira V
authors.initials: IV
authors.lastname: Gupta
authors.affiliation: Global Clinical Development, Novartis, Uxbridge, United Kingdom.
authors.forename: Oliver J
authors.initials: OJ
authors.lastname: Wright
authors.affiliation: Department of Internal Medicine, Universitair Ziekenhuis Gent, Gent, Belgium.
authors.forename: Fritz
authors.initials: F
authors.lastname: Offner
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000069461:Bendamustine Hydrochloride; C527517:ofatumumab