First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10337187" target="_blank" >RIV/00064165:_____/16:10337187 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/16:10337187
Result on the web
<a href="http://dx.doi.org/10.1016/S1470-2045(16)30051-1" target="_blank" >http://dx.doi.org/10.1016/S1470-2045(16)30051-1</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S1470-2045(16)30051-1" target="_blank" >10.1016/S1470-2045(16)30051-1</a>
Alternative languages
Result language
angličtina
Original language name
First-line chemoimmunotherapy with bendamustine and rituximab versus fludarabine, cyclophosphamide, and rituximab in patients with advanced chronic lymphocytic leukaemia (CLL10): an international, open-label, randomised, phase 3, non-inferiority trial
Original language description
Background: Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab is the standard therapy for physically fit patients with advanced chronic lymphocytic leukaemia. This international phase 3 study compared the efficacy and tolerance of the standard therapy with a potentially less toxic combination consisting of bendamustine and rituximab. Methods: Treatment-naive fit patients with chronic lymphocytic leukaemia (aged 33-81 years) without del(17p) were enrolled after undergoing a central screening process. Patients were randomly assigned (1:1) with a computer-generated randomisation list using randomly permuted blocks with a block size of eight and were stratified according to participating country and Binet stage. Patients were allocated to receive six cycles of intravenous fludarabine (25 mg/m2 per day) and cyclophosphamide (250 mg/m2 per day) for the first 3 days or to intravenous bendamustine (90 mg/m2 per day) for the first 2 days of each cycle. Rituximab 375 mg/m2 was given intravenously in both groups on day 0 of cycle 1 and subsequently was given at 500 mg/m2 during the next five cycles on day 1. The primary endpoint was progression-free survival with the objective to assess non-inferiority of bendamustine and rituximab to the standard therapy. We aimed to show that the 2-year progression-free survival with bendamustine and rituximab was not 67.5% or less with a corresponding non-inferiority margin of 1.388 for the hazard ratio (HR) based on the 90.4% CI. The final analysis was done by intention to treat. The study is registered with ClinicalTrials.gov, number NCT%2000769522.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FD - Oncology and haematology
OECD FORD branch
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Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Lancet Oncology
ISSN
1470-2045
e-ISSN
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Volume of the periodical
17
Issue of the periodical within the volume
7
Country of publishing house
US - UNITED STATES
Number of pages
15
Pages from-to
928-942
UT code for WoS article
000378947100058
EID of the result in the Scopus database
2-s2.0-84969523604