Tests navtemadlin added to ruxolitinib in myelofibrosis patients with a weak response
Tests navtemadlin with ruxolitinib in adults with myelofibrosis responding poorly to ruxolitinib.
Plain-language title generated from the registry record
Registry title: Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Key facts
- Where
- Alessandria, Ancona, Bologna, Brescia, Catania, Florence, Forlì, Milan, Novara, Orbassano, Palermo, Pavia, Pesaro, Reggio Emilia, Rome, Turin, and Varese, ItalySee the 18 sites
- Phase
- Phase 3
Where in Italy
- National Hospital SS. Antonio e Biagio e Cesare ArrigoAlessandria, ItalyTaking people
- Marche University HospitalAncona, ItalyTaking people
- Polyclinic S. Orsola-MalpighiBologna, ItalyTaking people
- ASST Spedali Civili BresciaBrescia, ItalyTaking people
- University Hospital "G.Rodolico - San Marco"Catania, ItalyTaking people
- Careggi University HospitalFlorence, ItalyTaking people
- Institute of Romagna for Cancer Research "Dino Amadori" - IRCCS IRSTForlì, ItalyTaking people
- European Institute of Oncology (IEO), IRCCSMilan, ItalyTaking people
- Maggiore Polyclinic Hospital, Foundation IRCCS Ca' GrandaMilan, ItalyTaking people
- University Hospital "Maggiore della Carita" of NovaraNovara, ItalyTaking people
- University Hospital San Luigi GonzagaOrbassano, ItalyTaking people
- University Polyclinic Hospital "Paolo Giaccone" PalermoPalermo, ItalyTaking people
- Polyclinic San Matteo, IRCCSPavia, ItalyTaking people
- Local Health Company of Pesaro and UrbinoPesaro, ItalyTaking people
- Hospital Arcispedale S. Maria Nuova of Reggio EmiliaReggio Emilia, ItalyTaking people
- Hospital S. Eugenio- Rome 2 ASLRome, ItalyTaking people
- City of Health and Science of TurinTurin, ItalyTaking people
- ASST Sette Laghi HospitalVarese, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kartos Therapeutics, Inc.
- Trial code
- NCT06479135
- Record updated
- 25 September 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria; High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS); Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2; JAK-inhibitor treatment naive; PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing; ECOG performance status of 0 to 2; Treatment with a stable dose of ruxolitinib; Suboptimal response to run-in ruxolitinib treatment.
Exclusion: Prior Splenectomy; Splenic irradiation within 3 months prior to the first dose; Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy; Eligible for Bone Marrow Transplant; Peripheral blood or bone marrow blast count ≥ 10 percent; Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\^9/L; Peripheral blood or bone marrow blast count ≥ 10 percent.