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: 31 Oct 2017

At a glance

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

    • 31 Oct 2017 According to a Geron Corporation media release, expanded part 1 of this trial is open for patient enrollment.
    • 31 Oct 2017 According to a Geron Corporation media release, results for the original 32 patients in Part 1 of this trial are expected to be presented at an upcoming major medical conference. Based on preliminary data from this trial, the US FDA has 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.
    • 19 Oct 2017 Planned primary completion date changed from 17 Apr 2019 to 26 Feb 2021.
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