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ACTIVE NOT RECRUITING Phase 2

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

NCT02598661 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Imetelstat Sodium

Study Locations (20)

New York

  • Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects — New York
  • Columbia University Medical Center — New York
  • Weill Cornell Medical College-New York Presbyterian Hospital — New York

California

  • CBCC Global Research, Inc. — Bakersfield
  • UCLA Ronald Regan Medical Center — Los Angeles

Florida

  • BRCR Medical Center — Plantation
  • University of South Florida (USF) - H. Lee Moffitt Cancer Center — Tampa

Maryland

  • St. Agnes Healthcare, Inc — Baltimore
  • Center for Cancer and Blood Disorders — Bethesda

Ohio

  • Cleveland Clinic Taussig Cancer — Cleveland
  • The Ohio State Comprehensive Cancer Center — Columbus

Alabama

  • UAB Comprehensive Cancer Center — Birmingham

Arizona

  • Acrc/Arizona Clinical Research, Inc. — Tucson

Connecticut

  • Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital — New Haven

Trial Details

FieldValue
Enrollment Target 289 participants
Start Date 2016-01-12
Est. Completion 2026-10-13
Phase Phase 2

Sponsor

Geron Corporation

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02598661

The ClinicalTrials.gov registry entry for NCT02598661 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geron Corporation, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02598661 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02598661 about?

NCT02598661 is a clinical study titled "Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)". 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 t...

What is the current status of trial NCT02598661?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2016-01-12. Estimated completion is 2026-10-13.

What conditions does trial NCT02598661 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02598661?

The interventions under investigation include: Placebo (DRUG), Imetelstat Sodium (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02598661?

This trial is sponsored by Geron Corporation, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02598661 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial