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

J 2020

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

OFFNER, F., T. ROBAK, A. JANSSENS, K. G. BABU, J. KLOCZKO et. al.

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

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

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

Abstract

V originále

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.

Citovat

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.

@article{1681898,
   author = {Offner, F. and Robak, T. and Janssens, A. and Babu, K. G. and Kloczko, J. and Grosicki, S. and Mayer, Jiří and Panagiotidis, P. and Schuh, A. and Pettitt, A. and Montillo, M. and Werner, O. and Vincent, G. and Khanna, S. and Hillmen, P.},
   article_location = {England},
   article_number = {5},
   doi = {http://dx.doi.org/10.1111/bjh.16625},
   keywords = {ofatumumab; chlorambucil; Complement 1; anti-CD20 monoclonal antibodies; chronic lymphocytic leukaemia},
   language = {eng},
   issn = {0007-1048},
   journal = {British journal of haematology},
   title = {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},
   url = {https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.16625},
   volume = {190},
   year = {2020}
}

TY  - JOUR
ID  - 1681898
AU  - Offner, F. - Robak, T. - Janssens, A. - Babu, K. G. - Kloczko, J. - Grosicki, S. - Mayer, Jiří - Panagiotidis, P. - Schuh, A. - Pettitt, A. - Montillo, M. - Werner, O. - Vincent, G. - Khanna, S. - Hillmen, P.
PY  - 2020
TI  - 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
JF  - British journal of haematology
VL  - 190
IS  - 5
SP  - 736-740
EP  - 736-740
PB  - Wiley-Blackwell
SN  - 00071048
KW  - ofatumumab
KW  - chlorambucil
KW  - Complement 1
KW  - anti-CD20 monoclonal antibodies
KW  - chronic lymphocytic leukaemia
UR  - https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.16625
L2  - https://onlinelibrary.wiley.com/doi/full/10.1111/bjh.16625
N2  - 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.
ER  -

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. \textit{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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