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NCT02598661 · ClinicalTrials.gov record · last posted 2026-07-17

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

StatusActive, Not Recruiting
PhasePhase 2/3
Started2016-01-12
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to evaluate the efficacy and safety of imetelstat sodium in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Phase 2 study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat sodium to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Phase 3 study. A separate Ventricular Repolarization Substudy (QTc Substudy) will evaluate the effect of imetelstat sodium on ventricular repolarization. An Extension Phase has been included to allow continued treatment for those participants who are benefitting from imetelstat sodium and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.

Amendment record 97 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 97 times since 2015-11-04; most recent amendment 2026-06-26. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2023-09-28
Status change Recruiting→Active, Not Recruitingv82
2022-02-25
Status change Active, Not Recruiting→Recruitingv69
2021-11-16
Status change Recruiting→Active, Not Recruitingv68
2019-08-20
Status change Active, Not Recruiting→Recruitingv38
2019-02-12
Status change Recruiting→Active, Not Recruitingv35
2015-11-30
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT02598661
Lead Sponsor Geron Corporation
Conditions Myelodysplastic Syndromes
Enrollment 289 participants
Start Date 2016-01-12
Primary Completion 2023-10-13 (estimated)
Study Completion 2026-10-13 (estimated)
Updated on ClinicalTrials.gov 2026-07-17