Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, Primary Myelofibrosis, MF
In brief
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Key facts
- Study ID
- NCT06479135
- Run by
- Kartos Therapeutics, Inc.
- People needed
- 600
- Starts
- 2024-06-03
- Expected to finish
- 2028-12-31
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Hematology/Oncology Clinic - Los Angeles — Los Angeles, California, United States (enrolling)
- Scripps Health, Prebys Cancer Center — San Diego, California, United States (enrolling)
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States (enrolling)
- Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States (enrolling)
- Medical Oncology Hematology Consultants, PA — Newark, Delaware, United States (enrolling)
- MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States (enrolling)
- Mayo Clinic - Jacksonville — Jacksonville, Florida, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- AdventHealth Cancer Institute — Orlando, Florida, United States (enrolling)
- Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
- Mission Cancer + Blood — Des Moines, Iowa, United States (enrolling)
- University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (enrolling)
- Norton Cancer Institute — Louisville, Kentucky, United States (enrolling)
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States (enrolling)
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (enrolling)
- The Center for Cancer and Blood Disorders — Bethesda, Maryland, United States (enrolling)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
- Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion — Detroit, Michigan, United States (enrolling)
- Nebraska Hematology - Oncology, P.C. — Lincoln, Nebraska, United States (enrolling)
- Mohtaseb Cancer Center and Blood Disorders — Henderson, Nevada, United States (enrolling)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Brookdale University Hospital and Medical Center — Brooklyn, New York, United States (enrolling)
- Cayuga Cancer Center — Ithaca, New York, United States (enrolling)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
Full record on ClinicalTrials.gov
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