Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F20%3A00073671" target="_blank" >RIV/65269705:_____/20:00073671 - isvavai.cz</a>

Result on the web

<a href="https://www.tandfonline.com/doi/pdf/10.1080/10428194.2020.1795159?needAccess=true" target="_blank" >https://www.tandfonline.com/doi/pdf/10.1080/10428194.2020.1795159?needAccess=true</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1080/10428194.2020.1795159" target="_blank" >10.1080/10428194.2020.1795159</a>

Result language

angličtina

Original language name

Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma

Original language description

We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus &lt;= 6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286];p &lt; .0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455-0.822];p = .0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30205 - Hematology

Project

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2020

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Leukemia &amp; Lymphoma

ISSN

1042-8194

e-ISSN

—

Volume of the periodical

61

Issue of the periodical within the volume

13

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

3188-3197

UT code for WoS article

000556471600001

EID of the result in the Scopus database

2-s2.0-85089198842