Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
NCT06479135 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ruxolitinib
- DRUG Navtemadlin
- DRUG Navtemadlin placebo
Study Locations (20)
California
- UC San Diego Moores Cancer Center — La Jolla
- UCLA Hematology/Oncology Clinic - Los Angeles — Los Angeles
- Scripps Health, Prebys Cancer Center — San Diego
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
Florida
- Mayo Clinic - Jacksonville — Jacksonville
- University of Miami — Miami
- AdventHealth Cancer Institute — Orlando
- Moffitt Cancer Center — Tampa
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic - Phoenix — Phoenix
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Baltimore
- The Center for Cancer and Blood Disorders — Bethesda
Alabama
- UAB Hospital — Birmingham
Colorado
- Rocky Mountain Cancer Centers - Aurora — Aurora
Delaware
- Medical Oncology Hematology Consultants, PA — Newark
District of Columbia
- MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06479135
The ClinicalTrials.gov registry entry for NCT06479135 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kartos Therapeutics, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Myelofibrosis appearing as the primary indexed condition, and to 3 interventions — of which Ruxolitinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06479135 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06479135 about?
NCT06479135 is a clinical study titled "Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib". 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 t...
What is the current status of trial NCT06479135?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2024-06-03. Estimated completion is 2028-12-31.
What conditions does trial NCT06479135 study?
This clinical trial studies the following conditions: Myelofibrosis, Primary Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, MF. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06479135?
The interventions under investigation include: Ruxolitinib (DRUG), Navtemadlin (DRUG), Navtemadlin placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06479135?
This trial is sponsored by Kartos Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06479135 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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