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

ID#: NCT06479135

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: June 03, 2024

End Date: December 31, 2028

Contact Information:
John Mei
650-542-0136
Summary: 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.
Eligibility: 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
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