Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064165%3A_____%2F16%3A10329989" target="_blank" >RIV/00064165:_____/16:10329989 - isvavai.cz</a>
Alternative codes found
RIV/00216224:14110/16:00091731 RIV/00216208:11110/16:10329989 RIV/00216208:11150/16:10329989 RIV/00216208:11120/16:43912200 and 4 more
Result on the web
<a href="http://dx.doi.org/10.1016/S2352-3026(16)30045-X" target="_blank" >http://dx.doi.org/10.1016/S2352-3026(16)30045-X</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/S2352-3026(16)30045-X" target="_blank" >10.1016/S2352-3026(16)30045-X</a>
Alternative languages
Result language
angličtina
Original language name
Rituximab maintenance versus observation alone in patients with chronic lymphocytic leukaemia who respond to first-line or second-line rituximab-containing chemoimmunotherapy: final results of the AGMT CLL-8a Mabtenance randomised trial
Original language description
Background: In many patients with chronic lymphocytic leukaemia requiring treatment, induction therapy with rituximab plus chemotherapy improves outcomes compared with chemotherapy alone. In this study we aimed to investigate the potential of rituximab maintenance therapy to prolong disease control in patients who respond to rituximab-containing induction regimens. Methods: In this randomised, international, multicentre, open-label, phase 3 clinical trial, we enrolled patients who had achieved a complete response (CR), CR with incomplete bone marrow recovery (CRi), or partial response (PR) to first-line or second-line rituximab-containing chemoimmunotherapy and randomly assigned them in a 1:1 ratio (central block randomisation in the electronic case report form system) to either intravenous rituximab 375 mg/m2 every 3 months, or observation alone, for 2 years. Stratification was by country, line of treatment, type of chemotherapy added to the rituximab backbone, and degree of remission following induction. The primary endpoint was progression-free survival. Efficacy analysis was done in the intention-to-treat population. This is the final, event-triggered analysis. Final analysis was triggered by the occurrence of 92 events. This trial is registered with ClinicalTrials.gov, number NCT01118234.
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
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych 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
The Lancet Haematology
ISSN
2352-3026
e-ISSN
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Volume of the periodical
3
Issue of the periodical within the volume
7
Country of publishing house
GB - UNITED KINGDOM
Number of pages
13
Pages from-to
"E317"-"E329"
UT code for WoS article
000389069400007
EID of the result in the Scopus database
2-s2.0-84991702543