2015
Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study
DOUBEK, Michael, Yvona BRYCHTOVÁ, Anna PANOVSKÁ, Ludmila ŠEBEJOVÁ, Olga STEHLÍKOVÁ et. al.Basic information
Original name
Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study
Authors
DOUBEK, Michael (203 Czech Republic, guarantor, belonging to the institution), Yvona BRYCHTOVÁ (203 Czech Republic), Anna PANOVSKÁ (203 Czech Republic), Ludmila ŠEBEJOVÁ (203 Czech Republic), Olga STEHLÍKOVÁ (203 Czech Republic), Jana CHOVANCOVÁ (203 Czech Republic), Jitka MALČÍKOVÁ (203 Czech Republic, belonging to the institution), Jana ŠMARDOVÁ (203 Czech Republic), Karla PLEVOVÁ (203 Czech Republic, belonging to the institution), Pavlína VOLFOVÁ (203 Czech Republic), Martin TRBUŠEK (203 Czech Republic, belonging to the institution), Marek MRÁZ (203 Czech Republic, belonging to the institution), Denisa BAKEŠOVÁ (703 Slovakia), Jakub TRIZULJAK (703 Slovakia), Markéta HADRABOVÁ (203 Czech Republic), Petra OBRTLÍKOVÁ (203 Czech Republic), Josef KARBAN (203 Czech Republic), Lukáš SMOLEJ (203 Czech Republic), Alexandra OLTOVÁ (203 Czech Republic), Eva JELÍNKOVÁ (203 Czech Republic), Šárka POSPÍŠILOVÁ (203 Czech Republic, belonging to the institution) and Jiří MAYER (203 Czech Republic, belonging to the institution)
Edition
American Journal of Hematology, Hoboken, Wiley-Blackwell, 2015, 0361-8609
Other information
Language
English
Type of outcome
Article in a journal
Field of Study
30200 3.2 Clinical medicine
Country of publisher
United States of America
Confidentiality degree
is not subject to a state or trade secret
References:
Impact factor
Impact factor: 5.000
RIV identification code
RIV/00216224:14740/15:00082873
Organization unit
Central European Institute of Technology
UT WoS
000353393300020
Keywords in English
HIGH-DOSE METHYLPREDNISOLONE; RITUXIMAB; COMBINATION; FLUDARABINE; IBRUTINIB; EFFICACY; THERAPY; CD20
Tags
International impact, Reviewed
Changed: 23/12/2015 08:58, Martina Prášilová
Abstract
V originále
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 (NCT01310101). Am. J. Hematol. 90:417-421, 2015. (c) 2015 Wiley Periodicals, Inc.