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

Launched by KARTOS THERAPEUTICS, INC. · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medication called navtemadlin to an existing treatment called ruxolitinib can help patients with myelofibrosis experience better results than using ruxolitinib alone. Myelofibrosis is a type of blood cancer that affects bone marrow. In this study, patients who start with ruxolitinib and don't see enough improvement will be randomly assigned to receive either navtemadlin along with ruxolitinib or a placebo (a treatment that looks the same but has no active medication) with ruxolitinib. This random assignment helps ensure that the results are fair and reliable.

To be eligible for the trial, patients need to have a confirmed diagnosis of myelofibrosis and be between the ages of 65 and 74. They should not have previously received any treatment with JAK inhibitors, which are a type of medication used for myelofibrosis. During the study, participants will be monitored closely, and neither they nor their doctors will know which treatment they are receiving to ensure unbiased results. This trial is currently recruiting participants and aims to find out if the combination treatment can offer more benefits for patients struggling with their current therapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Ruxolitinib Alone Period:
• • 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
• Exclusion Criteria for Ruxolitinib Alone Period:
• • 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
• Inclusion Criteria for Randomized Period:
• • 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
• Exclusion Criteria for Randomized Period:
• • 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