Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) (MANIFEST-2)

 Myelofibrosis / Posted 1 week ago

Brief Summary:
A Phase 3, randomized, blinded study comparing pelabresib (CPI-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been previously treated with Janus kinase inhibitors (JAKi). Pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins.
  • Inclusion Criteria :
    • Aged ≥ 18 years
    • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia)
    • Adequate hematologic, renal, and hepatic function
    • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0
    • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
    • Spleen volume of ≥ 450 cm^3
    • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Exclusion Criteria :
    • Splenectomy or splenic irradiation in the previous 6 months
    • Chronic or active conditions and/or concomitant medication use that would prohibit treatment
    • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm
  • Study end date : April 2027
  • Wales-Based Study Contact : Snehal Akkaladevi
Contact details

University Hospital of Wales, Heath Park Road,Cardiff,CF14 4XW  Show Phone Number Snehal.Akkaladevi@wales.nhs.uk

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