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NCT04603495 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
A Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 430
- Enrollment target
- 20
- Study locations
NCT04603495: Active Phase 3 study of Myelofibrosis and Primary Myelofibrosis, sponsored by Novartis Pharmaceuticals.
NCT04603495 is a Phase 3 study of Myelofibrosis and Primary Myelofibrosis that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 430 participants, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (128% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04603495, a Phase 3 study of Myelofibrosis and Primary Myelofibrosis, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 430 participants
- Enrollment target
- 20
- Study locations
Study 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 Outcome
Splenic response was characterized by a reduction of at least 35% in spleen volume from baseline (SVR35), as determined by magnetic resonance imaging (MRI) or computerized tomography (CT), and evaluated through a blinded central radiology review at Week 24.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pelabresib
- DRUG Ruxolitinib
Study Locations (20)
California
- UC San Diego Moores Cancer Center - La Jolla
- USC/Norris Comprehensive Cancer Center - Los Angeles
- UCLA Medical Center - Los Angeles
New York
- Icahn School of Medicine at Mount Sinai - New York
- Memorial Sloan Kettering Cancer Center - New York
- Weill Cornell Medical College- New York Presbyterian Hospital - New York
Florida
- Mayo Clinic - Jacksonville
- Moffitt Cancer Center - Tampa
Texas
- MD Anderson Cancer Center - Houston
- University of Texas Health Science Center - San Antonio - San Antonio
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers - Chandler
Connecticut
- Yale University School of Medicine - New Haven
Illinois
- Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL - Decatur
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04603495 still lists
NCT04603495 is an interventional study that assigns participants to a tested intervention. The registered 430 participants enrollment target is mid-sized for trials with a published cap, above the 189-participant average among 61 other Myelofibrosis trials with a reported enrollment target (128% higher).
The record links to 4 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04603495 names 20 study sites across 14 states, led by California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04603495 about?
NCT04603495 is a clinical study titled "Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)". 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)...
What is the current status of trial NCT04603495?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 430 participants. The study started on 2021-04-09. Estimated completion is 2027-06-30.
What conditions does trial NCT04603495 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Post-Polycythemia Vera Myelofibrosis.
What interventions are being tested in trial NCT04603495?
The interventions under investigation include: Placebo (DRUG), Pelabresib (DRUG), Ruxolitinib (DRUG).
Who is sponsoring clinical trial NCT04603495?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04603495 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Myelofibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04603495's enrollment target sits among peer trials
430 4th of 61 higher than 58 of 61 other Myelofibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelofibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
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A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
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