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Taking people in ItalyPhase 3

Testing Navtemadlin Added to Ruxolitinib for Myelofibrosis Patients

Tests navtemadlin with ruxolitinib in adults with myelofibrosis responding poorly to ruxolitinib.

Key facts

Who runs it
Kartos Therapeutics Inc.
Where
Alexandria, Ancona, Bologna, Brescia, Catania, Florence, Meldola, Milan, Novara, Orbassano, Palermo, Pavia, Pesaro, Ravenna, Reggio Emilia, Rome, Turin, and Varese, ItalySee the 20 sitesAlso in 12 other countries, 102 sites
Trial code
Registry title
Adding Navtemadlin to Ruxolitinib for Patients with Myelofibrosis
Status
Recruiting
Phase
Phase 3
People taking part
126 people, planned
Started
16 Oct 2024
Expected to end
31 May 2029
Type of study
Interventional
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with myelofibrosis who have not had a JAK inhibitor before. Those who respond poorly to ruxolitinib can then be randomised to add navtemadlin or placebo.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Primary myelofibrosis, or myelofibrosis after polycythemia vera or after essential thrombocythemia. Risk category High, Intermediate-1 or Intermediate-2 (IPSS). ECOG performance status 0 to 2.
Earlier treatment
No earlier JAK inhibitor treatment. For the add-on part: a stable dose of ruxolitinib and a suboptimal response to the ruxolitinib run-in.
Biomarker or test result
For the add-on part: TP53 wild type (TP53WT), checked by central testing.

Main reasons for not taking part

  • Previous removal of the spleen (splenectomy)
  • Radiation to the spleen within 3 months before the first dose
  • Earlier treatment with BCL-XL, BET, MDM2, PI3K, PIM or XPO1 inhibitors, or p53-directed therapy
  • Able to have a bone marrow transplant
  • Blast cells in blood or bone marrow at 10% or more

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Ruxolitinib Run-In Period: 1. Adults ≥ 18 years of age able to provide informed consent
  • Ruxolitinib Run-In Period: 2. 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
  • Ruxolitinib Run-In Period: 3. High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
  • Ruxolitinib Run-In Period: 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Ruxolitinib Run-In Period: 5. JAK-inhibitor treatment naive
  • Randomized Add-on Period: 1. PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing
  • Randomized Add-on Period: 2. ECOG performance status of 0 to 2
  • Randomized Add-on Period: 3. Treatment with a stable dose of ruxolitinib
  • Randomized Add-on Period: 4. Suboptimal response to run-in ruxolitinib therapy

Who cannot take part

  • Ruxolitinib Run-In Period: 1. Prior Splenectomy
  • Ruxolitinib Run-In Period: 2. Splenic irradiation within 3 months prior to the first dose
  • Ruxolitinib Run-In Period: 3. Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53- directed therapy
  • Ruxolitinib Run-In Period: 4. Eligible for Bone Marrow Transplant
  • Ruxolitinib Run-In Period: 5. Peripheral blood or bone marrow blast count ≥ 10%
  • Randomized Period: 1. Peripheral blood or bone marrow blast count ≥ 10%

Where in Italy

Also in 12 other countries, 102 sites

  • Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare ArrigoAlexandria, ItalyTaking people
  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G SalesiAncona, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyTaking people
  • Careggi University HospitalFlorence, ItalyTaking people
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
  • Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • Istituto Europeo di Oncologia s.r.lMilan, ItalyTaking people
  • Azienda Ospedaliero Universitaria Maggiore della CaritàNovara, ItalyTaking people
  • Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassano, ItalyTaking people
  • Azienda Ospedaliera Universitaria Policlinico Paolo GiacconePalermo, ItalyTaking people
  • Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
  • Azienda Ospedaliera Ospedali Riuniti Marche NordPesaro, ItalyTaking people
  • Azienda Unità Sanitaria Locale della RomagnaRavenna, ItalyTaking people
  • Azienda USL IRCCS di Reggio EmiliaReggio Emilia, ItalyTaking people
  • Azienda Sanitaria Locale Roma 2Rome, ItalyTaking people
  • Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, ItalyTaking people
  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking people
  • Azienda Socio Sanitaria Territoriale Dei Sette LaghiVarese, ItalyTaking people

About the trial

What the trial wants to find out

Co-primary objectives:

Read full original descriptionShow less

To compare spleen volume reduction (SVR) between Arm 1 and Arm 2 To compare total symptom score (TSS) reduction between Arm 1 and Arm 2

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Plain-language title
Testing Navtemadlin Added to Ruxolitinib for Myelofibrosis PatientsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
14 September 2026