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@article{1299395,
author = {Doubek, Michael and Brychtová, Yvona and Panovská, Anna and Šebejová, Ludmila and Stehlíková, Olga and Chovancová, Jana and Malčíková, Jitka and Šmardová, Jana and Plevová, Karla and Volfová, Pavlína and Trbušek, Martin and Mráz, Marek and Bakešová, Denisa and Trizuljak, Jakub and Hadrabová, Markéta and Obrtlíková, Petra and Karban, Josef and Smolej, Lukáš and Oltová, Alexandra and Jelínková, Eva and Pospíšilová, Šárka and Mayer, Jiří},
article_location = {Hoboken},
article_number = {5},
doi = {http://dx.doi.org/10.1002/ajh.23964},
keywords = {HIGH-DOSE METHYLPREDNISOLONE; RITUXIMAB; COMBINATION; FLUDARABINE; IBRUTINIB; EFFICACY; THERAPY; CD20},
language = {eng},
issn = {0361-8609},
journal = {American Journal of Hematology},
title = {Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study},
url = {http://onlinelibrary.wiley.com/doi/10.1002/ajh.23964/epdf},
volume = {90},
year = {2015}
}
TY - JOUR
ID - 1299395
AU - Doubek, Michael - Brychtová, Yvona - Panovská, Anna - Šebejová, Ludmila - Stehlíková, Olga - Chovancová, Jana - Malčíková, Jitka - Šmardová, Jana - Plevová, Karla - Volfová, Pavlína - Trbušek, Martin - Mráz, Marek - Bakešová, Denisa - Trizuljak, Jakub - Hadrabová, Markéta - Obrtlíková, Petra - Karban, Josef - Smolej, Lukáš - Oltová, Alexandra - Jelínková, Eva - Pospíšilová, Šárka - Mayer, Jiří
PY - 2015
TI - Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study
JF - American Journal of Hematology
VL - 90
IS - 5
SP - 417-421
EP - 417-421
PB - Wiley-Blackwell
SN - 03618609
KW - HIGH-DOSE METHYLPREDNISOLONE
KW - RITUXIMAB
KW - COMBINATION
KW - FLUDARABINE
KW - IBRUTINIB
KW - EFFICACY
KW - THERAPY
KW - CD20
UR - http://onlinelibrary.wiley.com/doi/10.1002/ajh.23964/epdf
L2 - http://onlinelibrary.wiley.com/doi/10.1002/ajh.23964/epdf
N2 - 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.
ER -
DOUBEK, Michael, Yvona BRYCHTOVÁ, Anna PANOVSKÁ, Ludmila ŠEBEJOVÁ, Olga STEHLÍKOVÁ, Jana CHOVANCOVÁ, Jitka MALČÍKOVÁ, Jana ŠMARDOVÁ, Karla PLEVOVÁ, Pavlína VOLFOVÁ, Martin TRBUŠEK, Marek MRÁZ, Denisa BAKEŠOVÁ, Jakub TRIZULJAK, Markéta HADRABOVÁ, Petra OBRTLÍKOVÁ, Josef KARBAN, Lukáš SMOLEJ, Alexandra OLTOVÁ, Eva JELÍNKOVÁ, Šárka POSPÍŠILOVÁ a Jiří MAYER. Ofatumumab added to dexamethasone in patients with relapsed or refractory chronic lymphocytic leukemia: Results from a phase II study. \textit{American Journal of Hematology}. Hoboken: Wiley-Blackwell, 2015, roč.~90, č.~5, s.~417-421. ISSN~0361-8609. Dostupné z: https://dx.doi.org/10.1002/ajh.23964.
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