title: Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study.
abstract: The treatment of relapsed/refractory chronic lymphocytic leukemia (CLL) remains a challenging clinical issue. An important treatment option is the use of high-dose corticosteroids. The purpose of this clinical trial was to determine the efficacy and toxicity of an ofatumumab-dexamethasone (O-Dex) combination in relapsed or refractory CLL. The trial was an open-label, multicenter, nonrandomized, Phase II study. The O-Dex regimen consisted of intravenous ofatumumab (Cycle 1: 300 mg on day 1, 2,000 mg on days 8, 15, and 22; Cycles 2-6: 1,000 mg on days 1, 8, 15, and 22) and oral dexamethasone (40 mg on days 1-4 and 15-18; Cycles 1-6). The O-Dex regimen was given until best response, or a maximum of six cycles. Thirty-three patients (pts) were recruited. Twenty-four (73%) pts completed at least three cycles of therapy. The remaining nine pts were prematurely discontinued owing to Grade 3/4 infections (seven pts), disease progression (one pt), or uncontrollable diabetes mellitus (one pt). Overall response rates/complete remissions (ORR/CR) were achieved in 22/5 pts (67/15%). The median progression-free survival (PFS) was 10 months. In pts with p53 defects (n = 8), ORR/CR were achieved in 5/2 pts (63/25%) with a median PFS of 10.5 months. The median overall survival (OS) was 34 months. The Grades 3-5 infectious toxicity in 33% of pts represented the most frequent side effect during the treatment period. In conclusion, the O-Dex regimen shows a relatively high ORR and CR with promising findings for PFS and OS. The study was registered at www.clinicaltrials.gov (NCT01310101).
authors: Department of Internal Medicine-Hematology and Oncology, University Hospital Brno, Brno, Czech Republic; Central European Institute of Technology (CEITEC), Masaryk University Brno, Brno, Czech Republic.
authors: Michael
authors: M
authors: Doubek
authors: Yvona
authors: Y
authors: Brychtova
authors: Anna
authors: A
authors: Panovska
authors: Ludmila
authors: L
authors: Sebejova
authors: Olga
authors: O
authors: Stehlikova
authors: Jana
authors: J
authors: Chovancova
authors: Jitka
authors: J
authors: Malcikova
authors: Jana
authors: J
authors: Smardova
authors: Karla
authors: K
authors: Plevova
authors: Pavlina
authors: P
authors: Volfova
authors: Martin
authors: M
authors: Trbusek
authors: Marek
authors: M
authors: Mraz
authors: Denisa
authors: D
authors: Bakesova
authors: Jakub
authors: J
authors: Trizuljak
authors: Marketa
authors: M
authors: Hadrabova
authors: Petra
authors: P
authors: Obrtlikova
authors: Josef
authors: J
authors: Karban
authors: Lukas
authors: L
authors: Smolej
authors: Alexandra
authors: A
authors: Oltova
authors: Eva
authors: E
authors: Jelinkova
authors: Sarka
authors: S
authors: Pospisilova
authors: Jiri
authors: J
authors: Mayer
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003907:Dexamethasone / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D006801:Humans; D015451:Leukemia, Lymphocytic, Chronic, B-Cell / Q000188:drug therapy* / Q000235:genetics / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009154:Mutation; D012008:Recurrence; D016019:Survival Analysis; D016159:Tumor Suppressor Protein p53 / Q000235:genetics
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D016159:Tumor Suppressor Protein p53; D003907:Dexamethasone; C527517:ofatumumab