OFFNER, F., T. ROBAK, A. JANSSENS, K. G. BABU, J. KLOCZKO, S. GROSICKI, Jiří MAYER, P. PANAGIOTIDIS, A. SCHUH, A. PETTITT, M. MONTILLO, O. WERNER, G. VINCENT, S. KHANNA and P. HILLMEN. A five-year follow-up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: final analysis of the Complement 1 phase 3 trial. British journal of haematology. England: Wiley-Blackwell, 2020, vol. 190, No 5, p. 736-740. ISSN 0007-1048. Available from: https://dx.doi.org/10.1111/bjh.16625.
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Basic information
Original name A five-year follow-up of untreated patients with chronic lymphocytic leukaemia treated with ofatumumab and chlorambucil: final analysis of the Complement 1 phase 3 trial
Authors OFFNER, F. (56 Belgium, guarantor), T. ROBAK (616 Poland), A. JANSSENS (56 Belgium), K. G. BABU (356 India), J. KLOCZKO (616 Poland), S. GROSICKI (616 Poland), Jiří MAYER (203 Czech Republic, belonging to the institution), P. PANAGIOTIDIS (300 Greece), A. SCHUH (826 United Kingdom of Great Britain and Northern Ireland), A. PETTITT (826 United Kingdom of Great Britain and Northern Ireland), M. MONTILLO (380 Italy), O. WERNER (756 Switzerland), G. VINCENT (250 France), S. KHANNA (250 France) and P. HILLMEN (826 United Kingdom of Great Britain and Northern Ireland).
Edition British journal of haematology, England, Wiley-Blackwell, 2020, 0007-1048.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30205 Hematology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 6.998
RIV identification code RIV/00216224:14110/20:00116537
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1111/bjh.16625
UT WoS 000522527000001
Keywords in English ofatumumab; chlorambucil; Complement 1; anti-CD20 monoclonal antibodies; chronic lymphocytic leukaemia
Tags 14110212, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 30/9/2020 13:58.
Abstract
The Complement 1 trial investigated the efficacy and safety of ofatumumab + chlorambucil with chlorambucil monotherapy in patients with previously untreated chronic lymphocytic leukaemia (CLL). On long-term follow-up in the chemoimmunotherapy arm vs. the chemotherapy arm there was an estimated 12% (not significant) and 39% risk reduction in overall survival and progression-free survival, respectively. A high rate (61%) of treatment with next-line therapies in both the treatment arms may dilute any potential OS difference and confound the interpretation of the OS results. Addition of ofatumumab to chlorambucil demonstrated clinical benefit and tolerability as a frontline treatment option in patients unfit for fludarabine-containing therapy, with no new safety concerns.
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