Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F11%3A00053916" target="_blank" >RIV/00216224:14110/11:00053916 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11150/11:10107703 RIV/65269705:_____/11:#0001233 RIV/00179906:_____/11:10107703
Výsledek na webu
<a href="http://dx.doi.org/10.1016/S1470-2045(11)70150-4" target="_blank" >http://dx.doi.org/10.1016/S1470-2045(11)70150-4</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S1470-2045(11)70150-4" target="_blank" >10.1016/S1470-2045(11)70150-4</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial
Popis výsledku v původním jazyce
Background Bortezomib and rituximab have shown additive activity in preclinical models of lymphoma, and have been shown to be active and generally well tolerated in a randomised phase 2 study in patients with follicular and marginal zone lymphoma. We compared the efficacy and safety of rituximab alone or combined with bortezomib in patients with relapsed or refractory follicular lymphoma in a phase 3 setting. Methods In this multicentre phase 3 trial, rituximab-naive or rituximab-sensitive patients aged18 years or older with relapsed grade 1 or 2 follicular lymphoma were randomly assigned (1: 1) to receive five 35-day cycles consisting of intravenous infusions of rituximab 375 mg/m(2) on days 1, 8, 15, and 22 of cycle 1, and on day 1 of cycles 2-5, either alone or with bortezomib 1 . 6 mg/m(2), administered by intravenous injection on days 1, 8, 15, and 22 of all cycles. Randomisation was stratified by FLIPI score, previous use of rituximab, time since last therapy, and region.
Název v anglickém jazyce
Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial
Popis výsledku anglicky
Background Bortezomib and rituximab have shown additive activity in preclinical models of lymphoma, and have been shown to be active and generally well tolerated in a randomised phase 2 study in patients with follicular and marginal zone lymphoma. We compared the efficacy and safety of rituximab alone or combined with bortezomib in patients with relapsed or refractory follicular lymphoma in a phase 3 setting. Methods In this multicentre phase 3 trial, rituximab-naive or rituximab-sensitive patients aged18 years or older with relapsed grade 1 or 2 follicular lymphoma were randomly assigned (1: 1) to receive five 35-day cycles consisting of intravenous infusions of rituximab 375 mg/m(2) on days 1, 8, 15, and 22 of cycle 1, and on day 1 of cycles 2-5, either alone or with bortezomib 1 . 6 mg/m(2), administered by intravenous injection on days 1, 8, 15, and 22 of all cycles. Randomisation was stratified by FLIPI score, previous use of rituximab, time since last therapy, and region.
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FD - Onkologie a hematologie
OECD FORD obor
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Návaznosti výsledku
Projekt
—
Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2011
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Lancet Oncology
ISSN
1470-2045
e-ISSN
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Svazek periodika
12
Číslo periodika v rámci svazku
8
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
12
Strana od-do
773-784
Kód UT WoS článku
000293272100028
EID výsledku v databázi Scopus
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