Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) (NCT02598661)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Comprehensive Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (126 Sites)
Showing the first 25 of 126 sites.
- UAB Comprehensive Cancer Center — Birmingham, Alabama
- Acrc/Arizona Clinical Research, Inc. — Tucson, Arizona
- CBCC Global Research, Inc. — Bakersfield, California
- UCLA Ronald Regan Medical Center — Los Angeles, California
- Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital — New Haven, Connecticut
- BRCR Medical Center — Plantation, Florida
- University of South Florida (USF) - H. Lee Moffitt Cancer Center — Tampa, Florida
- Franciscan Health — Indianapolis, Indiana
- St. Agnes Healthcare, Inc — Baltimore, Maryland
- Center for Cancer and Blood Disorders — Bethesda, Maryland
- Washington University School of Medicine — St Louis, Missouri
- University of New Mexico Cancer Center — Albuquerque, New Mexico
- Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects — New York, New York
- Columbia University Medical Center — New York, New York
- Weill Cornell Medical College-New York Presbyterian Hospital — New York, New York
- Cleveland Clinic Taussig Cancer — Cleveland, Ohio
- The Ohio State Comprehensive Cancer Center — Columbus, Ohio
- Prairie lakes Healthcare system, Inc — Watertown, South Dakota
- Vanderbilt University Medical - Hematology-Oncology — Nashville, Tennessee
- Texas Oncology/Methodist Charlton Cancer Center — Dallas, Texas
- Simmons Comprehensive Cancer Center — Dallas, Texas
- Fred Hutchinson Cancer Research Center (FHCRC) — Seattle, Washington
- ZAS Middelheim — Antwerp, Antwerpen
- ZAS Cadix — Antwerp, Antwerpen
- GZA Ziekenhuizen - Campus Sint — Wilrijk, Antwerpen
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Myelodysplastic Syndromes
- ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions — Clovis, California
- Canakinumab With Darbepoetin Alfa in PTs With Lower-Risk MDS Who Have Failed ESA — Tampa, Florida
- A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS) — Lakewood, California
- Inqovi Maintenance Therapy in Myeloid Neoplasms — Boston, Massachusetts
- CPX-351 (Vyxeos™) for Transplant Eligible, Higher Risk Patients With Myelodysplastic Syndrome — Tampa, Florida
Explore by condition: All Myelodysplastic Syndromes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.