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ACTIVE NOT RECRUITING Phase 3

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

NCT04603495 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 430 participants
Start Date 2021-04-09
Est. Completion 2027-06-30
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04603495

The ClinicalTrials.gov registry entry for NCT04603495 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 430 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04603495 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04603495?

The interventions under investigation include: Placebo (DRUG), Pelabresib (DRUG), Ruxolitinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04603495?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial