This study is in progress, not accepting new patients

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

a study on Myelofibrosis Primary Myelofibrosis Polycythemia Vera Post-essential Thrombocythemia Myelofibrosis Essential Thrombocythemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Pelabresib, Ruxolitinib, Polycythemia Vera, Polycythemia, Thrombocytosis, Essential Thrombocythemia, Pelabresib + ruxolitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 cm3
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

You CAN'T join if...

  • 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

Locations

  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • UCLA Medical Center
    Los Angeles California 90095 United States
  • USC/Norris Comprehensive Cancer Center
    Los Angeles California 90033 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Constellation Pharmaceuticals
ID
NCT04603495
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 430 people participating
Last Updated