RecruitingMyelofibrosisPost-PV MFPost-ET Myelofibrosis

Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Eligible age

18+ yrs

Accepts

All genders

Locations

28 states

Healthy volunteers

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About this study

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Sponsor: Kartos Therapeutics, Inc.

You may qualify if…

✓ 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
✓ High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
✓ Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
✓ JAK-inhibitor treatment naive
✓ PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing
✓ ECOG performance status of 0 to 2
✓ Treatment with a stable dose of ruxolitinib
✓ Suboptimal response to run-in ruxolitinib treatment

You may not qualify if…

✕ Prior Splenectomy
✕ Splenic irradiation within 3 months prior to the first dose
✕ Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy
✕ Eligible for Bone Marrow Transplant
✕ Peripheral blood or bone marrow blast count ≥ 10 percent
✕ Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\^9/L
✕ Peripheral blood or bone marrow blast count ≥ 10 percent