Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study

Publication date: January 2015 Source:The Lancet Haematology, Volume 2, Issue 1 Author(s): Franck E Nicolini , Gabriel Etienne , Viviane Dubruille , Lydia Roy , Françoise Huguet , Laurence Legros , Stéphane Giraudier , Valérie Coiteux , Agnès Guerci-Bresler , Pascal Lenain , Pascale Cony-Makhoul , Martine Gardembas , Eric Hermet , Philippe Rousselot , Shanti Amé , Marie-Claude Gagnieu , Christine Pivot , Sandrine Hayette , Veronique Maguer-Satta , Madeleine Etienne , Stéphanie Dulucq , Delphine Rea , François-Xavier Mahon Background Nilotinib is now recommended for patients with newly diagnosed chronic myeloid leukaemia in chronic phase and leads to important rates of molecular response 4·5 log (MR4·5), allowing the prospect of therapy cessation. However, most patients do not reach this criterion and nilotinib is taken for lengthy periods, resulting in chronic or late-onset adverse events. Nilotinib combined with interferon might further increase rates of MR4·5, avoid late side-effects, and allow therapy cessation. In a phase 2 trial we aimed to assess the feasibility, safety, and deep molecular response of the combination of nilotinib (600 mg daily) and peginterferon alfa-2a in newly diagnosed patients with chronic-phase chronic myeloid leukaemia (CML). Methods In a non-randomised, open-label, phase 2 trial, we enrolled adult patients (age ≥18 years) without any organ failure who had BCR-ABL-positive, chronic-phase CML, at diagnosis. ...
Source: The Lancet Haematology - Category: Hematology Source Type: research