Obinutuzumab plus Lenalidomide (GALEN) for the treatment of relapse/refractory aggressive lymphoma: a phase II LYSA study - Archive ouverte HAL Access content directly
Journal Articles Leukemia Year : 2018

Obinutuzumab plus Lenalidomide (GALEN) for the treatment of relapse/refractory aggressive lymphoma: a phase II LYSA study

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Roch Houot
• Guillaume Cartron
  • Function : Author
• Fontanet Bijou
  • Function : Author
• Sophie de Guibert
  • Function : Author
Gilles A. Salles
  • Function : Author
Christophe Fruchart
  • Function : Author
Krimo Bouabdallah
  • Function : Author
Marie Maerevoet
  • Function : Author
Pierre Feugier
  • Function : Author
Hervé Tilly
  • Function : Author
Rene-Olivier Casasnovas
• Cécile Moluçon-Chabrot
  • Function : Author
Eric van den Neste
  • Function : Author
Pierre Zachee
  • Function : Author
Marc Andre
  • Function : Author
Christophe Bonnet
  • Function : Author
Corinne Haioun
  • Function : Author
Achiel van Hoof
  • Function : Author
Koen van Eygen
  • Function : Author
Lysiane Molina
  • Function : Author
Emmanuelle Nicolas-Virelizier
  • Function : Author
Philippe Ruminy
  • Function : Author
Franck Morschhauseur
  • Function : Author

Abstract

Lenalidomide is a potent immunomodulatory agent that has demonstrated clinical activity in the treatment of both diffuse large B cell lymphomas (DLBCL) and mantle cell lymphomas (MCL). In relapsed/refractory (R/R) DLBCL, two large prospective studies evaluating lenalidomide monotherapy demonstrated an overall response rate (ORR) of 28% (N = 108) and 27.5% (N = 51), respectively [1, 2]. In patients with R/R MCL patients, lenalidomide induced an ORR of 40% (N = 170) [3, 4]. In 2013, the FDA approved lenalidomide for the treatment of R/R MCL. Obinutuzumab is a unique type II glycoengineered monoclonal anti-CD20 antibody (Ab) with increased ADCC and increased direct cell death induction compared to rituximab. In monotherapy, obinutuzumab demonstrated efficacy in patients with MCL and DLBCL [5]. The ORR after treatment with obinutuzumab monotherapy was 28% and 27% in R/R DLBCL and MCL, respectively [5]. Furthermore, the combination of lenalidomide and rituximab (R 2 regimen) demonstrated promising efficacy in patients with follicular lymphoma (FL) [6, 7], MCL [8, 9], and DLBCL [10-13]. We hypothesized that the combination of obinutuzumab (GA) with lenalidomide (LEN) might be even more efficient while retaining a good safety profile. In a phase I B study, we previously identified 20 mg/day as the recommended dose (RD) of lenalidomide in * Franck Morschhauser
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Dates and versions

inserm-01934613 , version 1 (26-11-2018)

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  • HAL Id : inserm-01934613 , version 1

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Roch Houot, • Guillaume Cartron, • Fontanet Bijou, • Sophie de Guibert, Gilles A. Salles, et al.. Obinutuzumab plus Lenalidomide (GALEN) for the treatment of relapse/refractory aggressive lymphoma: a phase II LYSA study. Leukemia, 2018. ⟨inserm-01934613⟩
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