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Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT04603495•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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)

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Key Dates

Start Date

April 9, 2021

Primary Completion Date

August 23, 2023

Completion Date

June 30, 2027

Last Updated

December 17, 2025

Enrollment

430

ACTUAL participants

Conditions

MyelofibrosisPrimary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia Myelofibrosis

Interventions

Pelabresib

DRUG

Ruxolitinib

DRUG

Placebo

DRUG

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

View study

RECRUITINGPHASE1

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

NCT06343805

Primary MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

Momelotinib During and After HCT in Myelofibrosis

A Study of Elritercept Alone or Together With Ruxolitinib in Adults With Myelofibrosis

18F-FAPI PET/MRI Imaging in Myelofibrosis: a Prospective Observational Study.