Clinical trials

IMpactMF, our pivotal Phase 3 clinical trial in JAK inhibitor relapsed/refractory MF, is an open label, 2:1 randomized, controlled clinical trial of imetelstat to evaluate a potential improvement in overall survival compared to best available therapy. The trial is expected to enroll approximately 320 patients with intermediate-2 or high-risk MF who are relapsed or refractory to treatment with a Janus associated kinase (JAK) inhibitor. IMpactMF is open for screening and enrollment.

IMproveMF is a two-part Phase 1 clinical trial evaluating imetelstat in combination with ruxolitinib in patients with Intermediate-1, Intermediate-2 or high-risk frontline MF. In Part 1 of the study, the objective is to identify a safe dose of the combination treatment. In Part 2, the objective is to confirm the dose of the combination treatment of imetelstat and ruxolitinib, and to evaluate efficacy. IMproveMF is open for screening and enrollment.

IMpress is a Phase 2 clinical trial evaluating imetelstat as a single agent in patients with acute myeloid leukemia (AML) or high-risk MDS, who are relapsed/refractory/intolerant to hypomethylating agents, or HMAs. The objective of this trial is to evaluate the efficacy of single agent imetelstat in this patient population. The primary endpoint of this trial is overall response rate. IMpress is open for screening and enrollment.

IMAGINE is a two-part trial to evaluate the safety and preliminary efficacy of imetelstat in combination with azacitidine with or without venetoclax in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The objective is to evaluate the safety of imetelstat combined with azacitidine (Part A), then identify the optimal biological dose of imetelstat when used with azacitidine and venetoclax (Part B) in this patient population. The primary endpoint is to measure dose-limiting toxicities (DLTs) for imetelstat at two dose levels with azacitidine (Part A), and with azacitidine plus venetoclax during the first treatment cycle (Part B).