STUDY DESIGN IMerge is a Phase 2/3, multi-center study of imetelstat consisting of two parts. Part 1 is an open label, single arm design to assess the efficacy and safety of imetelstat. Approximately 30 participants will be enrolled and followed for safety, hematologic improvement and reduction in transfusion requirement. Part 2 of the study will be initiated if data from Part 1 are supportive of a satisfactory benefit/risk profile. In Part 2, approximately 170 patients will be randomized in a 2:1 ratio to receive either imetelstat or placebo. Each part of the study will consist of three stages: a screening phase, a treatment phase and a post-treatment follow-up phase. Participants will receive imetelstat (or placebo in Part 2) at a starting dose of 7.5 mg/kg given intravenously every 4 weeks, until disease progression, unacceptable toxicity, withdrawal of consent, or lack of response. Imetelstat will be evaluated by the rate of red blood cell transfusion independence for any consecutive period of eight weeks or longer.
CURRENT STATUS Based on preliminary data, Part 1 of IMerge was expanded to enroll approximately 20 additional participants who have not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and do not have a del(5q) chromosomal abnormality. The expanded Part 1 has been fully enrolled. To learn more about this study, including enrollment criteria, locations and current status, visit ClinicalTrials.gov.
Imetelstat, a telomerase inhibitor, is an investigational treatment for cancer and has not been approved by the FDA or any other regulatory agency.
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