Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design Journal Article


Authors: Mascarenhas, J.; Maher, K.; Rampal, R.; Bose, P.; Podoltsev, N.; Hong, J.; Chai, Y.; Kye, S.; Method, M.; Harrison, C.; on behalf of the SENTRY investigators
Article Title: Selinexor plus ruxolitinib in JAK inhibitor treatment-naïve myelofibrosis: SENTRY Phase 3 study design
Abstract: Selinexor is an investigational, selective oral XPO1 inhibitor that may inhibit myelofibrosis (MF)-relevant JAK/STAT and non-JAK/STAT pathways with potential synergy with ruxolitinib. SENTRY (XPORT-MF-034; NCT04562389) is a Phase 1/3 study evaluating safety and efficacy of selinexor plus ruxolitinib for treatment of patients with JAK inhibitor (JAKi) treatment-na & iuml;ve MF. The Phase 1 open label portion of the study included a 3 + 3 dose escalation and dose expansion, with no dose limiting toxicities observed. Described here is the Phase 3 randomized, double-blind, placebo-controlled study designed to evaluate selinexor+ruxolitinib versus placebo+ruxolitinib in patients with JAKi treatment-na & iuml;ve MF. Approximately 350 patients will be enrolled. Primary endpoints will evaluate spleen volume reduction >= 35% and absolute mean change in total symptom score from baseline to week 24. Clinical Trial Registration: NCT04562389 (ClinicalTrials.Gov).
Keywords: myelofibrosis; safety; clinical trials; trial; phase 3; open-label; ruxolitinib; selinexor
Journal Title: Future Oncology
Volume: 21
Issue: 7
ISSN: 1479-6694
Publisher: Future Medicine  
Date Published: 2025-01-01
Start Page: 807
End Page: 813
Language: English
ACCESSION: WOS:001415769400001
DOI: 10.1080/14796694.2025.2461393
PROVIDER: wos
PMCID: PMC11916360
PUBMED: 39911057
Notes: Article -- Source: Wos
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  1. Raajit Kumar Rampal
    339 Rampal