Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Public ClinicalTrials.gov record NCT02598661. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects With IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) That is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02598661
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 289 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 12, 2016 (Actual)
- Primary completion
- Oct 13, 2023 (Actual)
- Completion
- Oct 13, 2026 (Estimated)
- Last update posted
- Jul 17, 2026
2016 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| Acrc/Arizona Clinical Research, Inc. | Tucson | Arizona | 85715 | — |
| CBCC Global Research, Inc. | Bakersfield | California | 93309 | — |
| UCLA Ronald Regan Medical Center | Los Angeles | California | 90095 | — |
| Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital | New Haven | Connecticut | 06510-3220 | — |
| BRCR Medical Center | Plantation | Florida | 33326 | — |
| University of South Florida (USF) - H. Lee Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Franciscan Health | Indianapolis | Indiana | 46237-8601 | — |
| St. Agnes Healthcare, Inc | Baltimore | Maryland | 21229 | — |
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87131 | — |
| Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10065 | — |
| Cleveland Clinic Taussig Cancer | Cleveland | Ohio | 44195 | — |
| The Ohio State Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Prairie lakes Healthcare system, Inc | Watertown | South Dakota | 57201 | — |
| Vanderbilt University Medical - Hematology-Oncology | Nashville | Tennessee | 37232-6307 | — |
| Texas Oncology/Methodist Charlton Cancer Center | Dallas | Texas | 75237 | — |
| Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | — |
| Fred Hutchinson Cancer Research Center (FHCRC) | Seattle | Washington | 98109-1024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 104 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02598661, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 17, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02598661 live on ClinicalTrials.gov.