Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industrial
Disease
Leukemia/heme
Enrollment Eligibility
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