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

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
20-001572
Category
Hematology-Oncology
Oncology
Contact
Bruck Habtemariam
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04603495
For detailed technical eligibility, visit ClinicalTrials.gov.