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New drug may free MDS patients from frequent blood transfusions

NCT ID NCT02598661

Disease control Sponsor: Geron Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study tests a drug called imetelstat in adults with a bone marrow disorder (MDS) who currently need regular red blood cell transfusions because standard treatments have stopped working. The main goal is to see if the drug can help patients go 8 weeks or more without a transfusion. The study also checks for side effects and long-term safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

289 people

The number who actually took part.

Started

Jan 2016

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

myelodysplastic syndrome Myelodysplastic Syndromes Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes

Contacts and locations

Locations

  • A.O. Ospedale Niguarda Ca' Granda

    Milan, Lombardy, 20162, Italy

  • A.O. Universitaria Policlinico Tor Vergata

    Roma, Roma, 00133, Italy

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

    Roma, 189, Italy

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

    Ancona, 60020, Italy

  • AOU di Bologna Policlinico S. Orsola Malpighi

    Bologna, 40138, Italy

  • AZ Klina

    Brasschaat, 2930, Belgium

  • AZ Sint-Jan Burgge-Oostende

    Bruges, West-Vlaanderen, 8000, Belgium

  • Aberdeen Royal Infirmary

    Aberdeen, AB252ZL, United Kingdom

  • Acrc/Arizona Clinical Research, Inc.

    Tucson, Arizona, 85715, United States

  • Ankara University Medical Faculty - Hematology

    Ankara, Anatolia, 6590, Turkey (Türkiye)

  • Ars Medical sp. z o.o.

    Piła, Wielkopolskie Województwo, 64-920, Poland

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Az Groeninge

    Kortrijk, West-Vlaanderen, 8500, Belgium

  • Azienda Ospedaliera Universitaria Careggi di Firenze

    Florence, 50134, Italy

  • BRCR Medical Center

    Plantation, Florida, 33326, United States

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309, United States

  • CH Le Mans - HAEMATOLOGY

    Le Mans, Sarthe, 72037, France

  • CHRU Nancy Brabois

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France

  • CHRU de Lille - Hopital Claude Huriez - Maladies du Sang

    Lille, 59037, France

  • CHU - Hôpital Saint Louis - H

    Paris, Île-de-France Region, 75010, France

  • CHU Tours

    Tours, Centre-Val de Loire, 37044, France

  • CHU de Grenoble - Hôpital Albe

    La Tronche, Isère, 38700, France

  • CHU de Limoges, Hopital Dupuytren

    Limoges, Haute-Vienne, 87042, France

  • CHU de Poitiers

    Poitiers, Vienne, 86021, France

  • Carmel MC

    Haifa, 3436212, Israel

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817, United States

  • Centre Hospitalier Universitai

    Angers, 49100, France

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do, 58128, South Korea

  • City Clinical Hospital

    Moscow, 129301, Russia

  • Cleveland Clinic Taussig Cancer

    Cleveland, Ohio, 44195, United States

  • Clinics of Samarskiy GMU

    Samara, Volga, 443079, Russia

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Cukurova University Medical Faculty

    Adana, 1330, Turkey (Türkiye)

  • Ege Universitesi Tip Fakultesi - Hematology

    Izmir, İzmir, 35040, Turkey (Türkiye)

  • Emergency Hospital of Dzerzhinsk

    Dzerzhinsk, 606019, Russia

  • FGU-Russian Research Institut

    Saint Petersburg, 191024, Russia

  • FN Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • FN Kralovske Vinohrady

    Prague, 100 34, Czechia

  • Fachärztliche Gemeinschaftspraxis mit Schwerpunkt

    Dresden, Saxony, 1307, Germany

  • Fakultni nemocnice Brno

    Brno, Brno-město, 625 00, Czechia

  • Franciscan Health

    Indianapolis, Indiana, 46237-8601, United States

  • Fred Hutchinson Cancer Research Center (FHCRC)

    Seattle, Washington, 98109-1024, United States

  • GZA Ziekenhuizen - Campus Sint

    Wilrijk, Antwerpen, 2610, Belgium

  • Gachon University Gil Medical Center - oncology

    Incheon, Incheon Gwang'Yeogsi, 21565, South Korea

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

    Reggio Calabria, 89124, Italy

  • H.U.Pta.del Mar

    Cadiz, Cádiz, 11009, Spain

  • Ha'Emek Medical Center

    Afula, Northern District, 1834111, Israel

  • Hadassah Medical Organization

    Jerusalem, Jerusalem, 9112001, Israel

  • Hopital de l'Archet

    Nice, Alpes-Maritimes, 6202, France

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Univ. La Paz

    Madrid, 28046, Spain

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Doctor

    Valencia, Valencia, 46017, Spain

  • Hospital Universitario Nuestra Señora de Valme

    Seville, Sevilla, 41014, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital de Cruces

    Barakaldo, Vizcaya, 48903, Spain

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

    New York, New York, 10029, United States

  • Inselspital - Universitätsspital Bern

    Bern, Canton of Bern, 3010, Switzerland

  • Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr

    Lviv, Lviv Oblast, 79044, Ukraine

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028, Italy

  • Istituto Clinico Humanitas Rozzano, IRCCS

    Rozzano, Milano, 20089, Italy

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Johannes Gutenberg Universität

    Mainz, 55131, Germany

  • KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi

    Cherkasy, Cherkasy Oblast, 18009, Ukraine

  • KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi

    Dnipro, Dnipropetrovsk Oblast, 49102, Ukraine

  • Kantonsspital St. Gallen - Onkologie/Hämatologie

    Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

  • Kaplan Medical Center

    Rehovot, Hagalil Saint, 7610001, Israel

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ, Netherlands

  • Meir Medical Center

    Kfar Saba, Central District, 44281, Israel

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126, Russia

  • Nottingham City Hospital - Clinical Haematology

    Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

  • Oncologic Dispensary No.2

    Sochi, 354057, Russia

  • Ospedale di Circolo, PO Varese

    Varese, 21100, Italy

  • PRATIA Poznań

    Poznan, Ul. Gryfińska 1, 60-192, Poland

  • Prairie lakes Healthcare system, Inc

    Watertown, South Dakota, 57201, United States

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2L7, Canada

  • Pusan National University Hospital - Hematology and Oncology

    Seogu, Incheon, 42941, South Korea

  • Rabin Medical Center, Beilinson Hospital

    Petah Tikva, 4941492, Israel

  • Radboud Umcn

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039, Russia

  • SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii

    Olsztyn, Warmian-Masurian Voivodeship, 10-228, Poland

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Severance Hospital, Yonsei Uni

    Seoul, 3722, South Korea

  • Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390, United States

  • Southampton University Hospital

    Southampton, Southampton, SO16 6YD, United Kingdom

  • St. Agnes Healthcare, Inc

    Baltimore, Maryland, 21229, United States

  • Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz

    Aschaffenburg, 63739, Germany

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Tel Aviv, 49372, Israel

  • Texas Oncology/Methodist Charlton Cancer Center

    Dallas, Texas, 75237, United States

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

    Seoul, 06591, South Korea

  • The Chaim Sheba Medical Center

    Tel Litwinsky, Tel Aviv, 5265601, Israel

  • The Edith Wolfson Medical Center

    H̱olon, Central District, 58100, Israel

  • The Leeds Teaching Hospitals NHS Trust

    Leeds, Leeds, LS9 7TF, United Kingdom

  • The Ohio State Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • The Ottawa Hospital

    Ottawa, Ontario, K1G 8L6, Canada

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2, Canada

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35294, United States

  • UCLA Ronald Regan Medical Center

    Los Angeles, California, 90095, United States

  • UZ Leuven - Campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universitaetsspital Zuerich

    Zurich, Canton of Zurich, 8091, Switzerland

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ, Netherlands

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Universitatsklinikum Carl Gustav Carcus Dresden

    Dresden, 01307, Germany

  • University Hospital Bonn

    Bonn, 53127, Germany

  • University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • University Hospital Leipzig

    Leipzig, Saxony, 4107, Germany

  • University Hospital in Basel

    Basel, Basel-Stadt (de), 4031, Switzerland

  • University of Alberta Hospital - Hematology Research

    Edmonton, Alberta, T6G 2R3, Canada

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131, United States

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

    Tampa, Florida, 33612, United States

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225, Germany

  • Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

    Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

  • VU Medisch Centrum

    Amsterdam, 1081 HV, Netherlands

  • Vanderbilt University Medical - Hematology-Oncology

    Nashville, Tennessee, 37232-6307, United States

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10065, United States

  • Wojewódzki Szpital Specjalistyczny sp.z o.o.

    Słupsk, Pomeranian Voivodeship, 76-200, Poland

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

    New Haven, Connecticut, 06510-3220, United States

  • ZAS Cadix

    Antwerp, Antwerpen, 2030, Belgium

  • ZAS Middelheim

    Antwerp, Antwerpen, 2020, Belgium

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Other studies related to the condition(s) this trial covers.