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NCT02598661 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
A Phase 2 study of Myelodysplastic Syndromes, sponsored by Geron Corporation.
- Active
- Registry status
- Phase 2
- Development phase
- 289
- Enrollment target
- 20
- Study locations
NCT02598661 is a Phase 2 study of Myelodysplastic Syndromes that is active but no longer recruiting, run by Geron Corporation. The registered enrollment target is 289 participants, roughly in line with the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT02598661, a Phase 2 study of Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Geron Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 289 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2016-01-12 |
| Est. Completion | 2026-10-13 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 289 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target. The listed sponsor is Geron Corporation, which has 15 total studies on file at ClinicalTrials.gov.
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.
NCT02598661 reports 20 study locations spanning 14 distinct geographic areas - top geographies include New York, California, Florida.
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.
What interventions are being tested in trial NCT02598661?
The interventions under investigation include: Placebo (DRUG), Imetelstat Sodium (DRUG).
Who is sponsoring clinical trial NCT02598661?
This trial is sponsored by Geron Corporation, which has 15 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.