USO 23333
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-Naive Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (KRT-232-115)
Disease Types: Lymphoma & Hematologic
Eligibility Requirements:
1. Adults ≥ 18 years of age able to provide informed consent.
2. 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.
3. IPSS risk category of Intermediate-1, Intermediate-2, or High.
4. Spleen measuring ≥ 450 cm3 by MRI or CT scan (central review).
5. MF symptoms as defined by a baseline TSS of ≥ 10. Baseline TSS will be calculated as a
7-day average per MFSAF v4.0.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Adequate hematological, hepatic, and renal organ function (as per protocol definition and
within 28 days prior to the first dose of ruxolitinib monotherapy):
8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential must both use a highly effective contraception method during the study. In addition, after the last dose of study drug, female subjects must continue to use a highly effective method of contraception for one month and one week, and male subjects must continue to use a highly effective method of contraception for three months and one week. A woman is considered of childbearing potential (ie, fertile) following menarche and until becoming post-menopausal unless permanently sterile.
Available at:
- Hampton (CarePlex)
- Chesapeake
- Norfolk (Brock Cancer Center)
- Virginia Beach (Princess Anne)
- Williamsburg