Oral azacitidine compared with standard therapy in patients with relapsed or refractory follicular helper T-cell lymphoma (ORACLE): an open-label randomised, phase 3 study.

Fiche publication


Date publication

juin 2024

Journal

The Lancet. Haematology

Auteurs

Membres identifiés du Cancéropôle Est :
Dr CASASNOVAS Olivier, Pr FORNECKER Luc-Matthieu


Tous les auteurs :
Dupuis J, Bachy E, Morschhauser F, Cartron G, Fukuhara N, Daguindau N, Casasnovas RO, Snauwaert S, Gressin R, Fox CP, d'Amore FA, Staber PB, Tournilhac O, Bouabdallah K, Thieblemont C, André M, Rai S, Ennishi D, Gkasiamis A, Nishio M, Fornecker LM, Delfau-Larue MH, Sako N, Mule S, de Leval L, Gaulard P, Tsukasaki K, Lemonnier F

Résumé

Follicular helper T-cell lymphomas (TFHL) harbour frequent alterations in genes that regulate DNA methylation. Preliminary reports suggest that treatment with 5-azacitidine has clinical activity in patients with relapsed or refractory TFHL. We aimed to compare the oral form of azacitidine with investigator's choice standard therapy (ICT; ie, gemcitabine, bendamustine, or romidepsin) in patients with relapsed or refractory TFHL.

Mots clés

Humans, Male, Female, Aged, Middle Aged, Azacitidine, therapeutic use, Administration, Oral, Bendamustine Hydrochloride, therapeutic use, Gemcitabine, Lymphoma, Follicular, drug therapy, Deoxycytidine, analogs & derivatives, Depsipeptides, therapeutic use, Antineoplastic Combined Chemotherapy Protocols, therapeutic use, Antimetabolites, Antineoplastic, therapeutic use, Aged, 80 and over

Référence

Lancet Haematol. 2024 06;11(6):e406-e414