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

NCT04603495

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis

Interventions: Pelabresib, Ruxolitinib, Placebo

Countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (156)
  • Birmingham, Alabama, United States
  • Chandler, Arizona, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • New Haven, Connecticut, United States
  • Jacksonville, Florida, United States
  • Tampa, Florida, United States
  • Decatur, Illinois, United States
  • Indianapolis, Indiana, United States
  • Louisville, Kentucky, United States
  • Ann Arbor, Michigan, United States
  • St Louis, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Houston, Texas, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Brisbane, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Clayton, Victoria, Australia
  • Frankston, Victoria, Australia
  • Buderim, Australia
  • Nedlands, Australia
  • Graz, Austria
  • Linz, Austria
  • Linz, Austria
  • Salzburg, Austria
  • + 126 more on CT.gov