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
Date de révision : 27/04/2026
12 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 09/04/2025
Critères :
Critères d'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
Critères d'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%
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Centre Hospitalier Universitaire Amiens Picardie
80054 Amiens Cedex 1 France
Centre Hospitalier Universitaire De Nantes
44000 Nantes France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".