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Clinical Trial 21090

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT02598661

Phase: Phase II/III
Principal Investigator: Komrokji, Rami

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study 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

Summary

he purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.

Objective

1. To evaluate the efficacy and safety of imetelstat in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment; 2. To compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion dependent subjects with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment.

Treatments

Therapies

Therapy (NOS)

Medications

Imetelstat (GRN163L); Placebo ()

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) (Part 1) or randomization [Part 2 (Main Study)]. In Part 2 (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 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

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)

Part 2 (Main Study): a) Prior treatment with a hypomethylating agent (example [eg], azacitidine, decitabine); b) Prior treatment with lenalidomide

Additional Exclusion Criteria for Part 2 (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

QTcF >470 millisecond (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 bundle branch block or ventricular conduction delay (QRS >119 msec)

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

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