Active — Not RecruitingPhase 3

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

United States430 participantsStarted 2021-04-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 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

What they're measuring

Number of Participants With Splenic Response by Central Radiology Reads at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT04603495

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-23

Results submitted2024-08-23

View on ClinicalTrials.gov More Myelofibrosis trials