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Article Dans Une Revue Blood Année : 2021

A fixed-duration, measurable residual disease–guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial

1 Centre Léon Bérard [Lyon]
2 Service d'hématologie biologique [Avicenne]
3 CHU Pitié-Salpêtrière [AP-HP]
4 CHU ST-E - Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
5 CHU Nice - Centre Hospitalier Universitaire de Nice
6 CHU Bordeaux
7 HCL - Hospices Civils de Lyon
8 LBBE - Laboratoire de Biométrie et Biologie Evolutive - UMR 5558
9 Service de Biostatistiques [Lyon]
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 CHU Nantes - Centre hospitalier universitaire de Nantes
12 Centre Hospitalier Le Mans (CH Le Mans)
13 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
14 CHU Clermont-Ferrand
15 Service d'hématologie [Reims]
16 CHUGA - Centre Hospitalier Universitaire [CHU Grenoble]
17 CHU de Poitiers - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
18 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
19 Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
20 CHCB - Centre Hospitalier de la Côte Basque
21 CHR Metz-Thionville - Centre hospitalier régional Metz-Thionville
22 UM - Université de Montpellier
23 CHU Strasbourg - Centre Hospitalier Universitaire [Strasbourg]
24 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
25 Service d'hématologie [Tours]
26 CHU Angers - Centre Hospitalier Universitaire d'Angers
27 Laboratoire d'Hématologie Biologique [CHU Caen]
28 IPC - Institut Paoli-Calmettes
29 CLCC Henri Becquerel - Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
30 Unité de recherche clinique [Avicenne]
31 Service d'Hématologie [CHRU Nancy]
32 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
Kamel Laribi
Gilles Salles
Olivier Tournilhac

Résumé

Abstract Trials assessing first-line, fixed-duration approaches in chronic lymphocytic leukemia (CLL) are yielding promising activity, but few long-term data are available. We report follow-up data from a phase 2 trial (ICLL07 FILO) in previously untreated, medically fit patients (N = 135). Patients underwent obinutuzumab-ibrutinib induction for 9 months; then, following evaluation (N = 130 evaluable), those in complete remission and with bone marrow measurable residual disease (BM MRD) <0.01% (n = 10) received ibrutinib for 6 additional months; those in partial remission and/or with BM MRD ≥0.01%, the majority (n = 120), also received 4 cycles of immunochemotherapy (fludarabine/cyclophosphamide-obinutuzumab). Beyond end of treatment, responses were assessed every 3 month and peripheral blood MRD every 6 months. At median follow-up 36.7 months from treatment start, progression-free and overall survival rates (95% confidence interval) at 3 years were 95.7% (92.0% to 99.5%) and 98% (95.1% to 100%), respectively. Peripheral blood MRD <0.01% rates were 97%, 96%, 90%, 84%, and 89% at months 16, 22, 28, 34, and 40, respectively. No new treatment-related or serious adverse event occurred beyond end of treatment. Thus, in previously untreated, medically fit patients with CLL, a fixed-duration (15 months), MRD-guided approach achieved high survival rates, a persistent MRD benefit beyond the end of treatment, and low long-term toxicity. This trial was registered at www.clinicaltrials.gov as #NCT02666898.

Domaines

Hématologie

Dates et versions

hal-03231146 , version 1 (20-05-2021)

Identifiants

Citer

Anne-Sophie Michallet, Rémi Letestu, Magali Le Garff-Tavernier, Carmen Aanei, Michel Ticchioni, et al.. A fixed-duration, measurable residual disease–guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial. Blood, 2021, 137 (8), pp.1019-1023. ⟨10.1182/blood.2020008164⟩. ⟨hal-03231146⟩
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