POIESIS: This study is recruiting people with myelofibrosis to see if a combination of two targeted therapy drugs is more beneficial than oneA 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

Summary

To be eligible for this study you need to be diagnosed with myelofibrosis (MF), that is either PMF, post-PV MF, or post-ET MF, and you can't have had any prior treatment with a janus kinase (JAK) inhibitor.

Eligible participants will start by receiving the targeted therapy Ruxolitinib alone during the run-in period. Ruxolitinib is a JAK 1/2 inhibitor and is given orally twice a day.

Those who demonstrate a sub-optimal response from Ruxolitinib alone will then be randomly allocated (2:1) to receive Navtemadlin targeted therapy or a Navtemadlin placebo as an add-on treatment to their ongoing Ruxolitinib. Navtemadlin is an investigational MDM2 inhibitor given orally once daily on Days 1-7 of a 28-day cycle.

Conditions

This trial is treating patients with myelofibrosis

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