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.
Myelofibrosis, Post-PV MF, Post-ET Myelofibrosis, Primary Myelofibrosis, MF
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.
Study of Navtemadlin Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
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Mission Cancer + Blood, Des Moines, Iowa, United States, 50314
Norton Cancer Institute, Louisville, Kentucky, United States, 40207
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States, 70809
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States, 20817
Nebraska Hematology - Oncology, P.C., Lincoln, Nebraska, United States, 68506
Cayuga Medical Center at Ithaca, Ithaca, New York, United States, 14850
Gabrail Cancer Center, Canton, Ohio, United States, 44718
Fairview Hospital - Cleveland Clinic, Cleveland, Ohio, United States, 44111
Cleveland Clinic, Cleveland, Ohio, United States, 44195
Independence Family Health Center - Cleveland Clinic, Independence, Ohio, United States, 44131
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to
ALL
No
Kartos Therapeutics, Inc.,
2028-12-31