A Phase 3, Randomized, Double-blind, Active-Control Study of Pelabresib (CPI-0610) and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients (MANIFEST-2)

  • STATUS
    Recruiting
  • End date
    Apr 18, 2027
  • participants needed
    400
  • sponsor
    Constellation Pharmaceuticals
Updated on 18 September 2022

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.

Details
Condition Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Treatment Placebo, Ruxolitinib, CPI-0610, Pelabresib
Clinical Study IdentifierNCT04603495
SponsorConstellation Pharmaceuticals
Last Modified on18 September 2022

Eligibility

Yes No Not Sure

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
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