Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306)

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11150%2F20%3A10403102" target="_blank" >RIV/00216208:11150/20:10403102 - isvavai.cz</a>

Alternative codes found

RIV/00179906:_____/20:10403102

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=hK8P6L-y3J" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=hK8P6L-y3J</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/bjh.16255" target="_blank" >10.1111/bjh.16255</a>

Result language

angličtina

Original language name

Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306)

Original language description

PIX306 was a phase 3, randomised, single-blind, multicentre trial conducted in adult patients with diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) grade 3 who relapsed after &gt;=1 rituximab-containing regimen and were not eligible for a stem cell transplant. Patients were randomised 1:1 to pixantrone 50 mg/m2 or gemcitabine 1000 mg/m2 on days 1, 8 and 15 of a 28-day cycle, combined with rituximab 375 mg/m2 on day 1, for up to six cycles. Patients were followed for up to 96 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), complete response (CR) rate, overall response rate (ORR) and safety. Overall, 312 patients were randomised (median age 73.0 years). The study did not meet its primary endpoint. Median PFS [95% confidence interval (CI)] was 7.3 months (5.2-8.4) with pixantrone + rituximab (PIX + R) and 6.3 months (4.4-8.1) with gemcitabine + rituximab [GEM + R; hazard ratio (HR): 0.85; 95% CI 0.64-1.14; P = 0.28]. Median OS was 13.3 (10.1-19.8) months with PIX + R and 19.6 (12.4-31.9) months with GEM + R (HR: 1.13; 95% CI 0.83-1.53). ORR was 61.9% and 43.9% respectively and CR rate 35.5% and 21.7%. The incidence of adverse events, including cardiac events, was not statistically significant different between PIX + R and GEM + R.

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

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2020

Confidentiality

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

Name of the periodical

British Journal of Haematology

ISSN

0007-1048

e-ISSN

—

Volume of the periodical

188

Issue of the periodical within the volume

2

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

240-248

UT code for WoS article

000507431800008

EID of the result in the Scopus database

2-s2.0-85074768461