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 Jul 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 Jul 2017 Results from 32 patients enrolled in Part 1 of this trial published in a Geron Corporation media release.
    • 31 Jul 2017 According to a Geron Corporation media release, the Joint Steering Committee has decided to amend Part 1 of the protocol to enroll approximately 20 additional patients who are non-del5q and naive to HMA and lenalidomide treatment in order to increase the experience and confirm the benefit-risk profile of imetelstat dosed at 7.5 mg/kg every four weeks in this refined target patient population. Enrollment into the expanded Part 1 is expected to begin in the fourth quarter of 2017.
    • 27 Jul 2017 Planned End Date changed from 20 May 2020 to 28 Sep 2020.
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