Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
In brief
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.
Key facts
- Study ID
- NCT04603495
- Run by
- Novartis Pharmaceuticals
- People needed
- 430
- Starts
- 2021-04-09
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify 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
Where it is running
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers — Chandler, Arizona, United States
- UC San Diego Moores Cancer Center — La Jolla, California, United States
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
- UCLA Medical Center — Los Angeles, California, United States
- Yale University School of Medicine — New Haven, Connecticut, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL — Decatur, Illinois, United States
- Franciscan Health/Indiana blood and Marrow Transplantation — Indianapolis, Indiana, United States
- Norton Cancer Institute, St. Matthews Campus — Louisville, Kentucky, United States
- University of Michigan Medical Center — Ann Arbor, Michigan, United States
- Washington University — St Louis, Missouri, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Weill Cornell Medical College- New York Presbyterian Hospital — New York, New York, United States
- Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Texas Health Science Center - San Antonio — San Antonio, Texas, United States
- Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute — Seattle, Washington, United States
- Icon Cancer Centre — Brisbane, Queensland, Australia
- Royal Adelaide Hospital — Adelaide, South Australia, Australia
- Monash Health — Clayton, Victoria, Australia
- Peninsula Private Hospital Clinical Trials Unit — Frankston, Victoria, Australia
- USC Clinical Trials Centre Sunshine Coast Haematology and Oncology Clinic — Buderim, Australia
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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