Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (NCT06479135)
A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Hospital — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (215 Sites)
Showing the first 25 of 215 sites.
- UAB Hospital — Birmingham, Alabama
- Banner MD Anderson Cancer Center — Gilbert, Arizona
- Mayo Clinic - Phoenix — Phoenix, Arizona
- UC San Diego Moores Cancer Center — La Jolla, California
- UCLA Hematology/Oncology Clinic - Los Angeles — Los Angeles, California
- Scripps Health, Prebys Cancer Center — San Diego, California
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California
- Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado
- Medical Oncology Hematology Consultants, PA — Newark, Delaware
- MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia
- Mayo Clinic - Jacksonville — Jacksonville, Florida
- University of Miami — Miami, Florida
- AdventHealth Cancer Institute — Orlando, Florida
- Moffitt Cancer Center — Tampa, Florida
- Mission Cancer + Blood — Des Moines, Iowa
- University of Kansas Cancer Center - Westwood — Westwood, Kansas
- Norton Cancer Institute — Louisville, Kentucky
- Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland
- The Center for Cancer and Blood Disorders — Bethesda, Maryland
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Michigan Hospital — Ann Arbor, Michigan
- Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion — Detroit, Michigan
- Nebraska Hematology - Oncology, P.C. — Lincoln, Nebraska
- Mohtaseb Cancer Center and Blood Disorders — Henderson, Nevada
📞 Contact the Study Coordinator
Phone: (650) 542-0136
Email: jmei@kartosthera.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Myelofibrosis
- Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms — Birmingham, Alabama
- Study of Stem Cell Transplant vs. Non-Transplant Therapies in High-Risk Myelofibrosis — Calgary, Alberta
- Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis — Birmingham, Alabama
- Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2) — Birmingham, Alabama
- A Study to Evaluate Single Agent Selinexor Versus Physician's Choice in Participants With Previously Treated Myelofibrosis — Pasadena, California
- A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) — Newport Beach, California
Explore by condition: All Myelofibrosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.