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Clin Lymphoma Myeloma Leuk. 2015 Feb;15(2):e43-6. doi: 10.1016/j.clml.2014.07.013. Epub 2014 Aug 1.

Ofatumumab in refractory chronic lymphocytic leukemia: experience through the French early access program.

Author information

1
Unité Fonctionnelle Hémopathies Lymphoïdes, CHU Henri Mondor, Créteil, France. Electronic address: jehan.dupuis@hmn.aphp.fr.
2
HDJ Hématologie, Hôpital Saint Louis, Paris, France.
3
Service d'Hématologie, CHU d'Angers, Angers, France.
4
Service d'Hématologie, CHU Purpan, Toulouse, France.
5
Service d'Hématologie Clinique, CHU Pontchaillou, Rennes, France.
6
Unité de Recherche Clinique, Groupe Hospitalier Paris Seine Saint Denis, Bobigny, France.
7
Département d'Hématologie, Centre Henri Becquerel, Rouen, France.
8
Département d'Hématologie Clinique, Hôpital Pitié-Salpétrière, Paris, France.
9
Service d'hématologie clinique et thérapie cellulaire, Hôpital Haut Lévèque, CHU de Bordeaux, Pessac, France.
10
Service d'Oncologie et d'Hématologie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
11
Service d'Hématologie Clinique, CHRU de Brest, Brest, France.

Abstract

BACKGROUND:

The Autorisation Temporaire d'Utilisation (ATU) is an early access program available in France for drugs aimed at treating severe diseases not yet covered by a marketing authorization, for patients without any other therapeutic option and who cannot be included in a clinical trial.

PATIENTS AND METHODS:

This report presents the use of single-agent ofatumumab in 30 patients with advanced chronic lymphocytic leukemia (CLL) in the French ATU program.

RESULTS:

These very-high-risk patients had received multiple previous treatments (median = 6), and most had disease that was fludarabine-refractory or alemtuzumab-refractory (or both) or was unsuitable for alemtuzumab treatment. In the intent-to-treat analysis, the overall response rate was 47% (4 of 30, complete response; 10 of 30, partial response). Of 13 patients with 17p deletion, 6 displayed response to ofatumumab, including 2 complete responses. Treatment was well tolerated, with 17 grade 3 or 4 adverse events; 4 cases of grade 3 or 4 infusion reactions were reported, with favorable immediate outcome. Among nonhematologic complications, infections were the most frequent.

CONCLUSION:

The results confirm the efficacy and acceptable tolerability profile of ofatumumab as a single agent in severely ill patients with CLL. Attention should be paid to possible early infusion reactions to ofatumumab, as well as to the risk of infection.

KEYWORDS:

CD20; CLL; Ofatumumab; Relapsed/refractory; Temporary use authorization

PMID:
25193089
DOI:
10.1016/j.clml.2014.07.013
[Indexed for MEDLINE]
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