Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) (MANIFEST-2)
Myelofibrosis / Posted 8 months 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.
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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
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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