Imatinib Optimized Therapy Improves Major Molecular Response Rates in Patients with Chronic Myeloid Leukemia

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Johnson-Ansah, Hyacinthe | Maneglier, Benjamin | Huguet, Francoise | Legros, Laurence | Escoffre-Barbe, Martine | Gardembas, Martine | Cony-Makhoul, Pascale | Coiteux, Valerie | Sutton, Laurent | Abarah, Wajed | Pouaty, Camille | Pignon, Jean-Michel | Choufi, Bachra | Visanica, Sorin | Deau, Benedicte | Morisset, Laure | Cayssials, Emilie | Molimard, Mathieu | Bouchet, Stephane | Mahon, Francois-Xavier | Nicolini, Franck | Aegerter, Philippe | Cayuela, Jean-Michel | Delord, Marc | Bruzzoni-Giovanelli, Heriberto | Rousselot, Philippe

Edité par CCSD ; MDPI -

International audience. The registered dose for imatinib is 400 mg/d, despite high inter-patient variability in imatinib plasmatic exposure. Therapeutic drug monitoring (TDM) is routinely used to maximize a drug's efficacy or tolerance. We decided to conduct a prospective randomized trial (OPTIM-imatinib trial) to assess the value of TDM in patients with chronic phase chronic myelogenous treated with imatinib as first-line therapy (NCT02896842). Eligible patients started imatinib at 400 mg daily, followed by imatinib [C]min assessment. Patients considered underdosed ([C]min < 1000 ng/mL) were randomized in a dose-increase strategy aiming to reach the threshold of 1000 ng/mL (TDM arm) versus standard imatinib management (control arm). Patients with [C]min levels >/= 1000 ng/mL were treated following current European Leukemia Net recommendations (observational arm). The primary endpoint was the rate of major molecular response (MMR, BCR

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