Tocilizumab in combination with a standard induction chemotherapy in acute myeloid leukaemia patients (TOCILAM study): a single-centre, single-arm, phase 1 trialResearch in context

Background: In acute myeloid leukaemia (AML), interleukin-6 (IL-6) promotes chemo-resistance and its levels correlate with poor prognosis. IL-6 blockade may represent a promising therapeutic strategy. We aimed to test, tocilizumab, an anti-IL-6 receptor (R) monoclonal antibody in combination with st...

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Bibliographic Details
Published in:EClinicalMedicine 2023-10, Vol.64, p.102254
Main Authors: Pierre Peterlin, Alice Garnier, Amandine Le Bourgeois, Thierry Guillaume, Yannick Le Bris, Olivier Theisen, Marie C. Béné, Marion Eveillard, Marie Rimbert, Maxime Jullien, Lucie Planche, Joelle Gaschet, Patrice Chevallier
Format: Article
Language:English
Subjects:
Acute myeloid leukaemia
IL-6
Induction chemotherapy
Tocilizumab
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Summary:Background: In acute myeloid leukaemia (AML), interleukin-6 (IL-6) promotes chemo-resistance and its levels correlate with poor prognosis. IL-6 blockade may represent a promising therapeutic strategy. We aimed to test, tocilizumab, an anti-IL-6 receptor (R) monoclonal antibody in combination with standard intensive AML induction chemotherapy. Methods: This investigator-initiated single-centre phase 1 trial was conducted at Nantes University Hospital in France. According to a continual reassessment method, three escalating doses were tested of intravenous (IV) tocilizumab (4, 6, and 8 mg/kg) administered at day (d) 8 of a standard AML induction chemotherapy (IV idarubicine 8 mg/m2 d1 to d5 + IV cytarabine 100 mg/m2 d1 to d7). All adults (aged ≥ 18 years) with an Eastern Cooperative Oncology Group performance status of 0–2 and with a newly diagnosed (excluding patients with a favourable risk according to ELN-2017 classification if 
ISSN:2589-5370
2589-5370