A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

ClinicalTrials.gov ID: NCT07357727

Public ClinicalTrials.gov record NCT07357727. 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.

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ClinicalTrials.gov public records Last synced Oct 23, 2026, 3:57 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 (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive

Brief summary

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

The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.

Study identification

NCT ID: NCT07357727
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 460 participants

Conditions and interventions

Conditions

Interventions

Drug

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: May 27, 2026 (Actual)
Primary completion: May 17, 2028 (Estimated)
Completion: Dec 27, 2030 (Estimated)
Last update posted: Oct 23, 2026

2026 – 2030

United States locations

U.S. sites: 20
U.S. states: 12
U.S. cities: 20

Facility	City	State	ZIP	Site status
Rocky Mountain Cancer Centers	Denver	Colorado	80218	Recruiting
Yale University School Of Medicine	New Haven	Connecticut	06520	Recruiting
Florida Cancer Specialist South Reg	Fort Myers	Florida	33916	Recruiting
The Anderson Family Cancer Institute	Jupiter	Florida	33458	Recruiting
Miami NS Ins Baptist Health S FL	Miami	Florida	33176	Recruiting
Florida Cancer Specialists-North	St. Petersburg	Florida	33705	Recruiting
Florida Cancer Specialists East	Stuart	Florida	34994	Recruiting
Winship Cancer Institute of Emory University	Atlanta	Georgia	30322	Recruiting
University of Chicago Hospital	Chicago	Illinois	60637	Recruiting
Franciscan Health Indianapolis	Indianapolis	Indiana	42637	Recruiting
American Oncology Partners PA Center for Cancer and Blood Disorders	Bethesda	Maryland	20817	Recruiting
Summit Medical Group Oncology	Berkeley Heights	New Jersey	07922	Recruiting
New York Oncology Hematology P C	Albany	New York	12206	Recruiting
Columbia University Medical Center New York Presbyterian	New York	New York	10032	Recruiting
The Ohio State University Comprehensive Cancer Center	Columbus	Ohio	43221	Recruiting
Texas Oncology - Central South	Austin	Texas	78705	Recruiting
Texas Oncology PA Dallas Presbyterian Hospital	Dallas	Texas	75231	Recruiting
MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
SCRI Texas Oncology Northeast Texas	Tyler	Texas	75702	Recruiting
Fred Hutch Cancer Research	Seattle	Washington	98109	Recruiting

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 125 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07357727, 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 Oct 23, 2026 · Synced Oct 23, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07357727 live on ClinicalTrials.gov.

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