Cancer Therapeutics | Oncology Agents | Lymphomas & Myelomas
Resminostat in relapsed or refractory Hodgkin Lymphoma: Initial results of the SAPHIRE phase II trial with a novel oral histone deacetylase (HDAC) inhibitor
J Walewski*, E Pasziewicz-Kozik, G Borsaru, A Moicean, A Warszewska, K Strobel, A Biggi, B Hauns, A Mais, SW Henning, B Hentsch
*Corresponding author: J Walewski
Maria Sklodowska-Curie Memorial Institute and Oncology Center, Warszawa, Poland
F1000Posters 2010, 1: 705 (poster) [ENGLISH]
Poster [1.84 MB]
52nd American Society of Hematology Annual Meeting 2010, 3 - 6 Dec 2010, 2811
The SAPHIRE study evaluates the therapeutic activity of the novel oral pan-HDAC inhibitor resminostat in relapsed/refractory Hodgkin Lymphoma (HL) patients after high dose chemotherapy and autologous hematopoietic stem cell transplantation. Resminostat is administered orally at a once daily dose of 600 mg in 2-week cycles consisting of 5 consecutive days treatment followed by a 9 day treatment free period. Patients undergo assessment of disease status by computed tomography in combination with positron emission tomography (PET/CT); PET/CT scans are conducted after cycle 3 and cycle 6 and thereafter every 4th cycle during an optional follow-up treatment period.
The trial is designed as an open-label, single-arm international trial with a Simon Minimax design and clinical data of the first recruitment phase (18 pts) on the efficacy and safety of resminostat are presented.
Consultancy for 4SC AG.
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