Future oncology (London, England) · 2022
Phase III MANIFEST-2: pelabresib + ruxolitinib vs placebo + ruxolitinib in JAK inhibitor treatment-naive myelofibrosis.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Harrison Claire N, Gupta Vikas K, Gerds Aaron T, Rampal Raajit, Verstovsek Srdan, Talpaz Moshe, Kiladjian Jean-Jacques, Mesa Ruben, Kuykendall Andrew T, Vannucchi Alessandro M, Palandri Francesca, Grosicki Sebastian, Devos Timothy, Jourdan Eric, Wondergem Marielle J, Al-Ali Haifa Kathrin, Buxhofer-Ausch Veronika, Alvarez-Larrán Alberto, Patriarca Andrea, Kremyanskaya Marina, Mead Adam J, Akhani Sanjay, Sheikine Yuri, Colak Gozde, Mascarenhas John
Аннотация
Myelofibrosis (MF) is a clonal myeloproliferative neoplasm, typically associated with disease-related symptoms, splenomegaly, cytopenias and bone marrow fibrosis. Patients experience a significant symptom burden and a reduced life expectancy. Patients with MF receive ruxolitinib as the current standard of care, but the depth and durability of responses and the percentage of patients achieving clinical outcome measures are limited; thus, a significant unmet medical need exists. Pelabresib is an investigational small-molecule bromodomain and extraterminal domain inhibitor currently in clinical development for MF. The aim of this article is to describe the design of the ongoing, global, phase III, double-blind, placebo-controlled MANIFEST-2 study evaluating the efficacy and safety of pelabresib and ruxolitinib versus placebo and ruxolitinib in patients with JAKi treatment-naive MF. Clinical Trial Registration: NCT04603495 (ClinicalTrials.gov).