IMproveMF: Planned Phase 1 Clinical Trial in Frontline Myelofibrosis
IMproveMF is designed as a two-part Phase 1 clinical trial evaluating imetelstat in combination with ruxolitinib in patients with Intermediate-1, Intermediate-2 or High-risk frontline myelofibrosis. Up to 20 patients are planned to be enrolled in Part 1of the study with the objective to identify the safe dose of the combination treatment, while efficacy data is being collected.
Part 2 is also planned to enroll about 20 patients, with the objective to confirm the dose of the combination treatment of imetelstat and ruxolitinib and further evaluate efficacy. The primary objective for Part 2 is symptom response rate, defined as the proportion of patients who achieve a >50% reduction in Total Symptom Score at 24 weeks. Secondary objectives include change in fibrosis; spleen response rate, defined as the proportion of patients who achieve a >35% reduction in spleen volume from baseline as assessed by imaging; and the number of patients achieving complete remission, partial remission or clinical improvement.
We are expect the trial to start in the first half of 2022.