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ACTIVE NOT RECRUITING

NCT02598661

PHASE2/PHASE3

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

Sponsor: Geron Corporation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

289

Start Date

2016-01-12

Completion Date

2026-10-13

Last Updated

2026-01-05

Healthy Volunteers

Conditions

Myelodysplastic Syndromes

Interventions

DRUG

Imetelstat Sodium

Imetelstat sodium IV infusion.

DRUG

Placebo

Imetelstat sodium-matching placebo IV infusion.

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

Locations (126)

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Acrc/Arizona Clinical Research, Inc.

Tucson, Arizona, United States

CBCC Global Research, Inc.

Bakersfield, California, United States

UCLA Ronald Regan Medical Center

Los Angeles, California, United States

Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital

New Haven, Connecticut, United States

BRCR Medical Center

Plantation, Florida, United States

University of South Florida (USF) - H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Franciscan Health

Indianapolis, Indiana, United States

St. Agnes Healthcare, Inc

Baltimore, Maryland, United States

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic Taussig Cancer

Cleveland, Ohio, United States

The Ohio State Comprehensive Cancer Center

Columbus, Ohio, United States

Prairie lakes Healthcare system, Inc

Watertown, South Dakota, United States

Vanderbilt University Medical - Hematology-Oncology

Nashville, Tennessee, United States

Texas Oncology/Methodist Charlton Cancer Center

Dallas, Texas, United States

Simmons Comprehensive Cancer Center

Dallas, Texas, United States

Fred Hutchinson Cancer Research Center (FHCRC)

Seattle, Washington, United States

ZAS Middelheim

Antwerp, Antwerpen, Belgium

ZAS Cadix

Antwerp, Antwerpen, Belgium

GZA Ziekenhuizen - Campus Sint

Wilrijk, Antwerpen, Belgium

AZ Sint-Jan Burgge-Oostende

Bruges, West-Vlaanderen, Belgium

Az Groeninge

Kortrijk, West-Vlaanderen, Belgium

AZ Klina

Brasschaat, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Tom Baker Cancer Centre

Calgary, Alberta, Canada

University of Alberta Hospital - Hematology Research

Edmonton, Alberta, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Fakultni nemocnice Brno

Brno, Brno-město, Czechia

FN Hradec Kralove

Hradec Králové, Hradec Králové, Czechia

FN Kralovske Vinohrady

Prague, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, Czechia

Hopital de l'Archet

Nice, Alpes-Maritimes, France

CHU Tours

Tours, Centre-Val de Loire, France

CHU de Limoges, Hopital Dupuytren

Limoges, Haute-Vienne, France

CHU de Grenoble - Hôpital Albe

La Tronche, Isère, France

CHRU Nancy Brabois

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

CH Le Mans - HAEMATOLOGY

Le Mans, Sarthe, France

CHU de Poitiers

Poitiers, Vienne, France

Centre Hospitalier Universitai

Angers, France

CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

Lille, France

CHU - HÃ´pital Saint Louis - H

Paris, Île-de-France Region, France

University Hospital Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Fachärztliche Gemeinschaftspraxis mit Schwerpunkt

Dresden, Saxony, Germany

University Hospital Leipzig

Leipzig, Saxony, Germany

Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz

Aschaffenburg, Germany

University Hospital Bonn

Bonn, Germany

Universitatsklinikum Carl Gustav Carcus Dresden

Dresden, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Johannes Gutenberg Universität

Mainz, Germany

The Edith Wolfson Medical Center

H̱olon, Central District, Israel

Meir Medical Center

Kfar Saba, Central District, Israel

Kaplan Medical Center

Rehovot, Hagalil Saint, Israel

Hadassah Medical Organization

Jerusalem, Jerusalem, Israel

Ha'Emek Medical Center

Afula, Northern District, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Tel Aviv, Israel

The Chaim Sheba Medical Center

Tel Litwinsky, Tel Aviv, Israel

Carmel MC

Haifa, Israel

Rabin Medical Center, Beilinson Hospital

Petah Tikva, Israel

A.O. Ospedale Niguarda Ca' Granda

Milan, Lombardy, Italy

Istituto Clinico Humanitas Rozzano, IRCCS

Rozzano, Milano, Italy

Irccs Crob

Rionero in Vulture, Potenza, Italy

A.O. Universitaria Policlinico Tor Vergata

Roma, Roma, Italy

AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi

Ancona, Italy

AOU di Bologna Policlinico S. Orsola Malpighi

Bologna, Italy

Azienda Ospedaliera Universitaria Careggi di Firenze

Florence, Italy

Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria

Reggio Calabria, Italy

AO S. Andrea, Università degli Studi di Roma La Sapienza

Roma, Italy

Ospedale di Circolo, PO Varese

Varese, Italy

Radboud Umcn

Nijmegen, Gelderland, Netherlands

Meander Medisch Centrum

Amersfoort, Netherlands

VU Medisch Centrum

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Lower Silesian Voivodeship, Poland

Wojewódzki Szpital Specjalistyczny sp.z o.o.

Słupsk, Pomeranian Voivodeship, Poland

PRATIA Poznań

Poznan, Ul. Gryfińska 1, Poland

SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

Olsztyn, Warmian-Masurian Voivodeship, Poland

Ars Medical sp. z o.o.

Piła, Wielkopolskie Województwo, Poland

Clinics of Samarskiy GMU

Samara, Volga, Russia

Emergency Hospital of Dzerzhinsk

Dzerzhinsk, Russia

City Clinical Hospital

Moscow, Russia

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia

Ryazan Regional Clinical Hospital

Ryazan, Russia

FGU-Russian Research Institut

Saint Petersburg, Russia

Oncologic Dispensary No.2

Sochi, Russia

Pusan National University Hospital - Hematology and Oncology

Seogu, Incheon, South Korea

Gachon University Gil Medical Center - oncology

Incheon, Incheon Gwang'Yeogsi, South Korea

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Severance Hospital, Yonsei Uni

Seoul, South Korea

H.U.Pta.del Mar

Cadiz, Cádiz, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Nuestra Señora de Valme

Seville, Sevilla, Spain

Hospital Universitario Doctor

Valencia, Valencia, Spain

Hospital de Cruces

Barakaldo, Vizcaya, Spain

Hosp. Univ. Germans Trias I Pujol

Badalona, Spain

Hosp. Univ. Vall D Hebron

Barcelona, Spain

Hosp. Gral. Univ. Gregorio Maranon

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Clinico Univ. de Salamanca

Salamanca, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

University Hospital in Basel

Basel, Basel-Stadt (de), Switzerland

Inselspital - Universitätsspital Bern

Bern, Canton of Bern, Switzerland

Kantonsspital St. Gallen - Onkologie/Hämatologie

Sankt Gallen, Canton of St. Gallen, Switzerland

Universitaetsspital Zuerich

Zurich, Canton of Zurich, Switzerland

Ankara University Medical Faculty - Hematology

Ankara, Anatolia, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi - Hematology

Izmir, İzmir, Turkey (Türkiye)

Cukurova University Medical Faculty

Adana, Turkey (Türkiye)

KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi

Cherkasy, Cherkasy Oblast, Ukraine

KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi

Dnipro, Dnipropetrovsk Oblast, Ukraine

Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr

Lviv, Lviv Oblast, Ukraine

The Leeds Teaching Hospitals NHS Trust

Leeds, Leeds, United Kingdom

Nottingham City Hospital - Clinical Haematology

Nottingham, Nottinghamshire, United Kingdom

Southampton University Hospital

Southampton, Southampton, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (126)