Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT02598661
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02598661
Study Brief:
Protocol Section:
NCT02598661