Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
- Conditions
- MyelofibrosisPost-ET MyelofibrosisPrimary MyelofibrosisPost-PV MFMF
- Interventions
- Registration Number
- NCT06479135
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Navtemadlin Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Navtemadlin placebo Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 1 Ruxolitinib Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Ruxolitinib Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
- Primary Outcome Measures
Name Time Method To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2 24 weeks The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2 24 weeks The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
- Secondary Outcome Measures
Name Time Method To compare time to progression between Arm 1 and Arm 2 Up to 8 years Time to progression or death from any cause in subjects randomized to each arm
To compare overall survival (OS) between Arm 1 and Arm 2 Up to 8 years Time to death from any cause in subjects randomized to each arm
Related Research Topics
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Trial Locations
- Locations (214)
UAB Hospital
🇺🇸Birmingham, Alabama, United States
Banner MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Mayo Clinic - Phoenix
🇺🇸Phoenix, Arizona, United States
UC San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
UCLA Hematology/Oncology Clinic - Los Angeles
🇺🇸Los Angeles, California, United States
Scripps Health, Prebys Cancer Center
🇺🇸San Diego, California, United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
🇺🇸Washington D.C., District of Columbia, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Scroll for more (204 remaining)UAB Hospital🇺🇸Birmingham, Alabama, United States