Adding Navtemadlin to Ruxolitinib for Patients with Myelofibrosis
Key facts
- Where
- Budapest VIII, Nyíregyháza, Szekesfehervar és Szekszárd, MagyarországSee the 4 sites
- Phase
- 3. fázis
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyháza, MagyarországTaking people
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato KorhazSzekesfehervar, MagyarországTaking people
- Tolna Varmegyei Balassa Janos KorhazSzekszárd, MagyarországTaking 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
- EU 2023-504724-25-00
- Record updated
- 2026. szeptember 14.
- Original description
Co-primary objectives: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 Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Co-primary objectives:
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
Inclusion: 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.
Exclusion: 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%.