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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: Active Phase 2 study of Myelodysplastic Syndromes, sponsored by Geron Corporation.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% confidence interval (CI) was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
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 |
What the registry record for NCT02598661 still lists
NCT02598661 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 283-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target.
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02598661's enrollment target sits among peer trials
289 24th of 173 higher than 150 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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