A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Trial Profile

A Study to Evaluate Imetelstat (JNJ-63935937) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 16 Mar 2018

At a glance

  • Drugs Imetelstat (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms IMerge
  • Sponsors Geron Corporation; Janssen Research & Development
  • Most Recent Events

    • 16 Mar 2018 According to a Geron Corporation media release, the US FDA granted Fast Track designation to imetelstat for the potential treatment of adult patients with transfusion-dependent anemia due to Low or Intermediate-1 risk MDS who are non-del(5q) and who are refractory or resistant to treatment with an ESA. Janssen sponsored the application for Fast Track designation using preliminary data from this trial.
    • 16 Mar 2018 According to a Geron Corporation media release, the data presented at ASH also presented in an analyst and investor meeting in December 2017. An enrollment in the expanded Part 1 portion was completed in February 2018
    • 12 Dec 2017 Results (n=29) assessing efficacy and safety, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
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