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Resminostat in patients with relapsed or refractory Hodgkin lymphoma: results of the phase II SAPHIRE study
J. Walewski, E. Paszkiewicz-Kozik, G. Borsaru, A. Hellmann, A. Janikova, A. Warszewska, A. Mais, A. Ammendola, T. Herz, B. Krauss, SW. Henning,
Language English Country United States
Document type Clinical Trial, Phase II, Journal Article
- MeSH
- Biomarkers MeSH
- Drug Resistance, Neoplasm MeSH
- Adult MeSH
- Hodgkin Disease diagnosis drug therapy etiology mortality MeSH
- Histone Deacetylase Inhibitors administration & dosage adverse effects pharmacokinetics therapeutic use MeSH
- Kaplan-Meier Estimate MeSH
- Hydroxamic Acids administration & dosage adverse effects pharmacokinetics therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Retreatment MeSH
- Positron Emission Tomography Computed Tomography MeSH
- Positron-Emission Tomography MeSH
- Antineoplastic Agents administration & dosage adverse effects pharmacokinetics therapeutic use MeSH
- Recurrence MeSH
- Aged MeSH
- Sulfonamides administration & dosage adverse effects pharmacokinetics therapeutic use MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
This open-label, single-arm phase II study examined efficacy, safety, pharmacokinetics, and biomarkers of histone deacetylase (HDAC) inhibitor resminostat in patients with relapsed or refractory Hodgkin lymphoma. Thirty-seven heavily pretreated patients received 600 (19 patients) or 800 mg (18 patients) oral resminostat daily for the initial 5 days of 14-day treatment cycles. Objective response rate (ORR) (primary) was 34% reaching disease control in 54% patients. Most patients (69%) showed reduced tumor size and reduced [18F]-FDG uptake in target lesions (71%). Median progression-free survival (PFS) was 2.3 months (95%CI [1.3; 3.3]) and median overall survival (OS) was 12.5 months (95%CI [9.6; 18.6]). Patients who responded or stabilized under resminostat had a 10-month longer OS than patients who progressed. Efficacy assessment, pharmacodynamics, and exploratory biomarker results followed plasma levels, showed target engagement and epigenetic modulations. Common drug-related adverse events (AEs) were nausea, vomiting, anemia, thrombocytopenia, and fatigue, mainly grade 1 or 2.
b Clinical Hospital Coltea Bucharest Romania
Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic
Department of Lymphoid Malignancies Maria Skłodowska Curie Institute Oncology Center Warszawa Poland
References provided by Crossref.org
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