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Clinical Trials in Turkey / NCT02598661
Active, not recruiting Phase 2/3

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

NCT02598661 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 2/3
Started
2016-01-12
Last updated
2026-07-17

Condition(s) studied

Myelodysplastic Syndromes

Investigational drug(s) / intervention(s)

Imetelstat Sodium →Placebo

Imetelstat Sodium: Imetelstat sodium IV infusion.

Placebo: Imetelstat sodium-matching placebo IV infusion.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Man or woman greater than or equal to (≥) 18 years of age * Diagnosis of myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Cycle 1 Day 1 (C1D1) (Phase 2) or randomization (Phase 3). In Ventricular Repolarization Substudy, diagnosis of MDS or myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to C1D1 * International Prognostic Scoring System (IPSS) low Risk or intermediate-1 risk MDS * Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to Study Entry; pre-transfusion hemoglobin (Hb) should be less than or equal to (≤) 9.0 gram per deciliter (g/dL) to count towards the 4 units total * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: * Participant has known allergies, hypersensitivity, or intolerance to imetelstat sodium or its excipients * Participant has received an investigational drug or used an invasive investigational medical device within 30 days prior to Study Entry or is currently enrolled in an investigational study * Prior treatment with imetelstat sodium * Have received corticosteroids greater than (\>) 30 milligram per day (mg/day) prednisone or equivalent, or growth factor treatment within 4 weeks prior to study entry * Has received an erythropoiesis-stimulating agent (ESA) or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to study entry (8 weeks for long-acting ESAs) * Phase 3: a) Prior treatment with a hypomethylating agent (example \[eg\], azacitidine, decitabine); b) Prior treatment with lenalidomide Additional Exclusion Criteria for the Ventricular Repolarization Substudy: * Concurrent therapy with medications known to prolong the QT interval and have been associated with Torsade de pointes arrhythmia (TdP) * Cardiac function abnormalities on screening ECG as follows: * Resting heart rate outside of 50 to 100 beats per minute * QT interval by Fridericia's correction method (QTcF) \>470 millisecond (msec) (or QTcF \>490 msec in the presence of a right bundle branch block or ventricular conduction delay \[QRS \>119 msec\]), determined by central assessment based on the average value of a triplicate set of ECGs * Diagnosed or suspected congenital long QT syndrome * Family history of sudden unexpected death from cardiac-related causes if indicative of a pathogenic mutation of cardiac ion channels * Family history of congenital long QT syndrome * History of Mobitz II second degree or third degree heart block * Implantable pacemaker or automatic implantable cardioverter defibrillator * Complete left bundle branch block * Chronic or persistent atrial arrhythmia including atrial fibrillation and atrial flutter * History or presence of clinically relevant heart rhythm disturbances including atrial, junctional, re-entry, and ventricular tachycardia * Unusual T-wave morphology (i.e., bifid T-wave) likely to interfere with QT measurements * History or evidence for any of the following: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (example, pulmonary embolism, cerebrovascular accident including transient ischemic attacks) within 12 months prior to Cycle 1 Day 1, New York Heart Association (NYHA) Class II to IV heart disease * Presence of uncontrolled hypertension (persistent systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP ≥100 mmHg). Participants with a history of hypertension are permitted, provided that BP is controlled to within these limits by anti-hypertensive treatment * Any skin condition likely to interfere with electrocardiographic electrode placement or adhesion * History of thoracic surgery likely to cause abnormality of the electrical conduction through thoracic tissues

Primary outcome measure(s)

Trial sites (126)

FacilityCityRegionStatus
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
AZ Sint-Jan Burgge-Oostende Bruges West-Vlaanderen
Az Groeninge Kortrijk West-Vlaanderen
AZ Klina Brasschaat Belgium
Universitair Ziekenhuis Gent Ghent Belgium
UZ Leuven - Campus Gasthuisberg Leuven Belgium
Tom Baker Cancer Centre Calgary Alberta
University of Alberta Hospital - Hematology Research Edmonton Alberta
The Ottawa Hospital Ottawa Ontario
Sunnybrook Health Sciences Centre Toronto Ontario
Princess Margaret Hospital Toronto Ontario
Jewish General Hospital Montreal Quebec
Fakultni nemocnice Brno Brno Brno-město
FN Hradec Kralove Hradec Králové Hradec Králové
FN Kralovske Vinohrady Prague Czechia
Vseobecna fakultni nemocnice v Praze Prague Czechia

+ 86 more sites — see the full list on the official registry below.

More Geron Corporation trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02598661 on ClinicalTrials.gov ↗ ← All trials in Turkey