Phase 2/3 Study to Evaluate Imetelstat in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
This clinical trial is being conducted by Janssen Research & Development (Janssen) under the terms of an exclusive worldwide license and collaboration agreement with Geron. The first patient in the IMerge study was dosed in January 2016.
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.
Based on preliminary data, Part 1 of IMerge is being expanded and is currently open to enrollment of 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. 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.
IMerge Study Design