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Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT04603495

Public ClinicalTrials.gov record NCT04603495. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 11:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04603495
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
430 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 9, 2021 (Actual)
Primary completion
Aug 23, 2023 (Actual)
Completion
Jun 30, 2027 (Estimated)
Last update posted
Jul 17, 2026

2021 – 2027

United States locations

U.S. sites
20
U.S. states
14
U.S. cities
17
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294-3300 —
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers Chandler Arizona 85224 —
UC San Diego Moores Cancer Center La Jolla California 92093 —
USC/Norris Comprehensive Cancer Center Los Angeles California 90033 —
UCLA Medical Center Los Angeles California 90095 —
Yale University School of Medicine New Haven Connecticut 06510 —
Mayo Clinic Jacksonville Florida 32224 —
Moffitt Cancer Center Tampa Florida 33612 —
Decatur Memorial Hospital Cancer Care Center of Decatur/Cancer Care Specialists of IL Decatur Illinois 62526 —
Franciscan Health/Indiana blood and Marrow Transplantation Indianapolis Indiana 46237 —
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky 40207 —
University of Michigan Medical Center Ann Arbor Michigan 48109 —
Washington University St Louis Missouri 63110 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Weill Cornell Medical College- New York Presbyterian Hospital New York New York 10065 —
Cleveland Clinic Taussig Cancer Center Cleveland Ohio 44195 —
MD Anderson Cancer Center Houston Texas 77030 —
University of Texas Health Science Center - San Antonio San Antonio Texas 78229 —
Center for Blood Disorders and Cellular Therapy, Swedish Cancer Institute Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 136 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04603495, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 17, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04603495 live on ClinicalTrials.gov.

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