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Haematologica. 2015 Apr;100(4):511-6. doi: 10.3324/haematol.2014.118158. Epub 2015 Jan 16.

Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia.

Author information

1
Hematology, Hospital Santa Creu i Sant Pau, Barcelona, Spain.
2
Niguarda Ca' Granda Hospital, Milano, Italy.
3
1 Department of Internal Medicine, University of Athens, Laikon General Hospital, Athens, Greece.
4
The Christie NHS Foundation Trust, Manchester, UK.
5
Hôpitaux Universitaire Henri Mondor, Créteil, France.
6
Churchill Hospital, Oxford, UK.
7
Karolinska University Hospital Huddinge, Stockholm, Sweden.
8
Rigshospitalet, Copenhagen, Denmark.
9
St. James's University Hospital, Leeds, UK.
10
Department of Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.
11
Charles University Hospital, Praha, Czech Republic.
12
Catholic University Sacred Heart, Rome, Italy.
13
Department of Internal Medicine III, Ulm University, Germany.
14
University Hospital Hradec Kralove, Czech Republic.
15
Department of Onco-Hematology, University Vita-Salute San Raffaele and Scientific Institut San Raffaele, Milano, Italy.
16
Hôpital Avicenne, Bobigny, France.
17
Hematology, Medical University of Vienna, Austria.
18
G. Papanicolaou Hospital, Thessaloniki, Greece.
19
Hematology, Trafford General Hospital, Manchester, UK.
20
Groupe Hospitalier Pitié Salpêtrière, Paris, France.
21
Hospital General de Albacete, Albacete, Spain.
22
Policlinico di Modena, Italy.
23
IRST Meldola, Italy.
24
Azienda Ospedaliero Universitaria Careggi, Firenze, Italy.
25
Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
26
ULSS 18-Rovigo Ospedale "S.Maria della Misericordia', Rovigo, Italy.
27
dACRO Research & Education Group, University of Glasgow, UK.
28
Hematology, Hospital Clínic, Barcelona, Spain emontse@clinic.ub.es.

Abstract

We report the largest retrospective, phase IV non-interventional, observational study of ofatumumab therapy in heavily pre-treated patients with poor-prognosis chronic lymphocytic leukemia. Total number of patients was 103; median age was 65 years (range 39-85). Median number of prior lines of therapy was 4 (range 1-13), including, in most cases, rituximab-, fludarabine- and alemtuzumab-based regimens; 13 patients had been allografted. Of 113 adverse events, 28 (29%) were considered to be directly related to ofatumumab. Grade 3-4 toxicities included neutropenia (10%), thrombocytopenia (5%), anemia (3%), pneumonia (17%), and fever (3%). Two heavily pre-treated patients developed progressive multifocal leukoencephalopathy. On an intention-to-treat analysis, the overall response rate was 22% (3 complete response, 1 incomplete complete response). Median progression-free and overall survival times were 5 and 11 months, respectively. This study confirms in a daily-life setting the feasibility and acceptable toxicity of ofatumumab treatment in advanced chronic lymphocytic leukemia. The complete response rate, however, was low. Therefore, treatment with ofatumumab should be moved to earlier phases of the disease. Ideally, this should be done in combination with other agents, as recently approved for ofatumumab plus chlorambucil as front-line treatment for patients unfit for fludarabine. This study is registered at clinicaltrials.gov identifier:01453062.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01453062.

PMID:
25596264
PMCID:
PMC4380724
DOI:
10.3324/haematol.2014.118158
[Indexed for MEDLINE]
Free PMC Article

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