Study details
This study evaluates the effectiveness of adding navtemadlin to standard ruxolitinib therapy in patients with myelofibrosis whose previous treatment response has been insufficient.
Title: 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.
ClinicalTrials.gov ID:
NCT06479135
Principal Investigator:
prof. Marta Sobas, MD, PhD
Study description
Recruitment status: Open
Study phase: Phase 3
Simplified inclusion criteria:
• Confirmed diagnosis of myelofibrosis
• Stable dose of ruxolitinib for at least 8 weeks
• Suboptimal response (persistent splenomegaly or symptoms)
• Adequate kidney and liver function
Simplified exclusion criteria:
• Prior stem cell transplant or urgent transplant eligibility
• High blast count
• Active serious infections (including HIV, HBV, HCV)
• Pregnancy or breastfeeding
• Severe uncontrolled comorbidities
Contact
Clinical trial coordinator
Justyna Korzenecka
e-mail: justyna.korzenecka@cm.umk.pl