Journal article
Dulanermin with rituximab in patients with relapsed indolent B-cell lymphoma: an open-label phase 1b/2 randomised study
CY Cheah, D Belada, MA Fanale, A Janikova, MS Czucman, IW Flinn, AV Kapp, A Ashkenazi, S Kelley, GL Bray, S Holden, JF Seymour
Lancet Haematology | Published : 2015
Abstract
Background Dulanermin—a non-polyhistidine-tagged soluble recombinant human apoptosis ligand 2 (Apo2L) or tumour-necrosis-factor-related apoptosis-inducing-ligand (TRAIL)—has pro-apoptotic activity in a range of cancers and synergistic preclinical activity with rituximab against lymphoma in vivo. We aimed to assess the safety, pharmacokinetics, and efficacy of dulanermin and rituximab in patients with relapsed indolent B-cell non-Hodgkin lymphoma. Methods We did an open-label phase 1b/2 randomised study. Four study centres in the USA enrolled patients into phase 1b, and 27 study centres in the USA, Italy, Australia, France, Czech Republic, New Zealand, and Poland enrolled patients into phase ..
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Funding Acknowledgements
This study was funded by Genentech (South San Francisco, CA, USA) and Amgen (Thousand Oaks, CA, USA). We thank the patients, carers, investigators, sub-investigators, and research nurses who participated in the study.