Clinical trial NCT02598661: Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes
Imetelstat Sodium
GRN163L
Relapsed/refractory to ESAs
Transfusion dependent
IMerge
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2015-11-06
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a Phase 2/3, multicenter study of imetelstat sodium in which 289 participants were enrolled.

* Phase 2 is an open-label, single-arm design to assess the efficacy and safety of imetelstat sodium. A total of 57 participants were enrolled in Phase 2, including the expansion cohort.
* Phase 3 is a double-blind, randomized design to compare the efficacy of imetelstat sodium with placebo. In the Phase 3 study, 178 participants were enrolled and randomized in a 2:1 ratio to receive either imetelstat sodium or placebo, respectively.
* In a separate Ventricular Repolarization (VR) Substudy (QTc Substudy), 54 participants were enrolled and randomized 2:1 to receive either imetelstat sodium or placebo. If after a minimum of 2 treatment cycles in the VR substudy, a participant has no significant change to packed red blood cell (pRBC) transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant may be unblinded. If the participant was on placebo treatment, he/she may be permitted to start treatment with imetelstat sodium.

The Extension Phase was initiated at the end of the Phase 3 study (24 months after the last participant was randomized in the Phase 3) and will continue until participants who entered Phase 3 study participated in the study for up to 5 years from the first dose of imetelstat sodium (including treatment and follow-up), or 3 years of post-treatment follow-up from the last dose of study treatment, whichever occurs later, or until death, withdrawal of consent, study termination, or until a participant is lost to follow-up. Participants ongoing on imetelstat sodium and considered to be benefiting from treatment per Investigator in the Phase 3 Study or Ventricular Repolarization Substudy, have the option to continue receiving imetelstat sodium in the Extension Phase. Participants in the follow-up phase for the Phase 3 study or Ventricular Repolarization Substudy have the option to continue the follow-up in the Extension Phase.

The Phase 2, Phase 3, and VR Substudy all consist of 3 phases: a Screening phase (up to 28 days); a treatment phase; and a post-treatment follow-up phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study (whichever occurs first). The Extension Phase of the study will consist of an extended treatment phase and an extended follow-up phase which will continue until death, lost to follow-up, withdrawal of consent, or the End of the Study (whichever occurs first).

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

Primary outcomes:
measure: Phase 2: Percentage of Participants Without Any Red Blood Cell (RBC) Transfusion During Any Consecutive 8-Weeks Period (All Participants)
timeFrame: Up to 5 years in Phase 2
measure: Phase 2: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period in Target Population
timeFrame: Up to 5 years in Phase 2
measure: Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period
timeFrame: Up to 3.7 years in Phase 3
Secondary outcomes:
measure: Phase 2 and Phase 3: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Deaths
timeFrame: Adverse events: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3; Deaths: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
measure: Phase 2 and Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 24-Weeks Period
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Time to the 8-Weeks RBC Transfusion Independence (TI)
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Time to the 24-Weeks RBC TI
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Duration of RBC TI
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Percentage of Participants With Hematologic Improvement Including Erythroid Response (HI-E) as Per International Working Group (IWG) Response Criteria 2006
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2: Percentage of Participants With Complete Remission (CR), Partial Remission (PR), or Marrow Complete Remission (mCR) as Per International Working Group (IWG) Response Criteria 2006 as Assessed by the Investigator
timeFrame: Up to 5 years in Phase 2
measure: Phase 3: Percentage of Participants With CR, PR, or mCR as Per IWG Response Criteria 2006 as Assessed by the Independent Review Committee (IRC)
timeFrame: Up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Overall Survival (OS)
timeFrame: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
measure: Phase 2 and Phase 3: Progression Free Survival (PFS)
timeFrame: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
measure: Phase 2 and Phase 3: Time to Progression to Acute Myeloid Leukemia (AML)
timeFrame: Up to 6.6 years in Phase 2 and up to 4 years in Phase 3
measure: Phase 2 and Phase 3: Amount of RBC Transfusions in the Best 8-week Interval
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Percent Change in RBC Transfusions Relative to Prior Transfusion Burden
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Percentage of Participants Who Received Any Myeloid Growth Factors
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Duration of Myeloid Growth Factors Administration
timeFrame: Up to 5 years in Phase 2 and up to 3.7 years in Phase 3
measure: Phase 2 and Phase 3: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose on Cycle 1 Day 1 and pre-dose on Day 1 of every 3 cycles from Cycle 4 up to Cycle 66 in Phase 2 and Cycle 34 in Phase 3 (each cycle length= 28 days)
measure: Phase 2 and Phase 3: Area Under the Drug Concentration-Plasma Time Curve From Time Zero to Time 28 Days (AUC0-28d)
timeFrame: Cycle 1 (Days 1 to 28) (Cycle duration= 28 days)
measure: Phase 2 and Phase 3: Percentage of Participants With Anti-drug Antibodies (ADA) to Imetelstat Sodium
timeFrame: Pre-dose on Cycle 1 Day 1 and pre-dose on Day 1 of every 3 cycles from Cycle 4 up to Cycle 66 in Phase 2 and Cycle 34 in Phase 3 (each cycle length= 28 days)
measure: Phase 3: Medical Resource Utilization Assessed Based on Percentage of Participants With Outpatient Medical Encounters
timeFrame: Up to 3.7 years in Phase 3
measure: Phase 3: Medical Resource Utilization Assessed Based on Duration of Hospitalization
timeFrame: Up to 3.7 years in Phase 3
measure: QTc Substudy: Change From Baseline in QT Interval by Fridericia's Correction Method (ΔQTcF)
timeFrame: Baseline, Cycle 1, Day 1: 0.5, 1, 2, 4, 6, and 8 hours post-dose (cycle length= 28 days)
Other outcomes:
measure: Extension Phase: Number of Participants With AEs
timeFrame: Up to approximately 3 years in the extension phase
measure: Extension Phase: Overall Survival
timeFrame: Up to approximately 3 years in the extension phase
measure: Extension Phase: Progression Free Survival (PFS) Survival
timeFrame: Up to approximately 3 years in the extension phase
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Tucson
country: United States
facility: Acrc/Arizona Clinical Research, Inc.
state: Arizona
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc.
state: California
city: Los Angeles
country: United States
facility: UCLA Ronald Regan Medical Center
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital (YNHH) - Smilow Cancer Hospital
state: Connecticut
city: Plantation
country: United States
facility: BRCR Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida (USF) - H. Lee Moffitt Cancer Center
state: Florida
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: Baltimore
country: United States
facility: St. Agnes Healthcare, Inc
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Program for the Protection of Human Subjects
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer
state: Ohio
city: Columbus
country: United States
facility: The Ohio State Comprehensive Cancer Center
state: Ohio
city: Watertown
country: United States
facility: Prairie lakes Healthcare system, Inc
state: South Dakota
city: Nashville
country: United States
facility: Vanderbilt University Medical - Hematology-Oncology
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology/Methodist Charlton Cancer Center
state: Texas
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center (FHCRC)
state: Washington
city: Wilrijk
country: Belgium
facility: GZA Ziekenhuizen - Campus Sint
state: Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Burgge-Oostende
state: West-Vlaanderen
city: Kortrijk
country: Belgium
facility: Az Groeninge
state: West-Vlaanderen
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Antwerpen
country: Belgium
facility: ZNA Cadix
city: Brasschaat
country: Belgium
facility: AZ Klina
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Hematology Research
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno
state: Brno-město
city: Hradec Králové
country: Czechia
facility: FN Hradec Kralove
city: Praha 10
country: Czechia
facility: FN Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Nice
country: France
facility: Hopital de l'Archet
state: Alpes-Maritimes
city: Tours
country: France
facility: CHU Tours
state: Centre
city: Limoges
country: France
facility: CHU de Limoges, Hopital Dupuytren
state: Haute-Vienne
city: La Tronche
country: France
facility: CHU de Grenoble - Hôpital Albe
state: Isère
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU Nancy Brabois
state: Meurthe-et-Moselle
city: Le Mans
country: France
facility: CH Le Mans - HAEMATOLOGY
state: Sarthe
city: Poitiers
country: France
facility: CHU de Poitiers
state: Vienne
city: Angers
country: France
facility: Centre Hospitalier Universitai
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez - Maladies du Sang
city: Paris
country: France
facility: CHU - HÃ´pital Saint Louis - H
state: Île-de-France
city: Freiburg
country: Germany
facility: University Hospital Freiburg
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Fachärztliche Gemeinschaftspraxis mit Schwerpunkt
state: Sachsen
city: Leipzig
country: Germany
facility: University Hospital Leipzig
state: Sachsen
city: Aschaffenburg
country: Germany
facility: Studienzentrum für Hämatologie, Onkologie,Diabetologie, Endoskopie und Fußambulanz
city: Bonn
country: Germany
facility: University Hospital Bonn
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carcus Dresden
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Mainz
country: Germany
facility: Johannes Gutenberg Universität
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
state: Hagalil Saint
city: H̱olon
country: Israel
facility: The Edith Wolfson Medical Center
state: HaMerkaz
city: Kfar Saba
country: Israel
facility: Meir Medical Center
state: HaMerkaz
city: Afula
country: Israel
facility: Ha'Emek Medical Center
state: HaZafon
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
state: Tel-Aviv
city: Tel HaShomer
country: Israel
facility: The Chaim Sheba Medical Center
state: Tel-Aviv
city: Haifa
country: Israel
facility: Carmel MC
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Milano
country: Italy
facility: A.O. Ospedale Niguarda Ca' Granda
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Rozzano, IRCCS
state: Milano
city: Rionero In Vulture
country: Italy
facility: Irccs Crob
state: Potenza
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I G.M. Lancisi G. Salesi
city: Bologna
country: Italy
facility: AOU di Bologna Policlinico S. Orsola Malpighi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi di Firenze
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
city: Roma
country: Italy
facility: A.O. Universitaria Policlinico Tor Vergata
city: Roma
country: Italy
facility: AO S. Andrea, Università degli Studi di Roma La Sapienza
city: Varese
country: Italy
facility: Ospedale di Circolo, PO Varese
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center - oncology
state: Incheon Gwang'yeogsi
city: Seogu
country: Korea, Republic of
facility: Pusan National University Hospital - Hematology and Oncology
state: Incheon
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: South Jeolla
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei Uni
city: Nijmegen
country: Netherlands
facility: Radboud Umcn
state: Gelderland
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego
state: Dolnoslaskie
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
state: Kościerzyna
city: Słupsk
country: Poland
facility: Wojewódzki Szpital Specjalistyczny sp.z o.o.
state: Pomorskie
city: Olsztyn
country: Poland
facility: SPZOZ MSWiA z Warminsko - Mazurskim Centrum Onkologii
state: Warminsko-mazurskie
city: Piła
country: Poland
facility: Ars Medical sp. z o.o.
state: Wielkopolskie Województwo
city: Samara
country: Russian Federation
facility: Clinics of Samarskiy GMU
state: Volga
city: Dzerzhinsk
country: Russian Federation
facility: Emergency Hospital of Dzerzhinsk
city: Moscow
country: Russian Federation
facility: City Clinical Hospital
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Region Clinical Hospital
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Hospital
city: Saint Petersburg
country: Russian Federation
facility: FGU-Russian Research Institut
city: Sochi
country: Russian Federation
facility: Oncologic Dispensary No.2
city: Cadiz
country: Spain
facility: H.U.Pta.del Mar
state: Cádiz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Badalona
country: Spain
facility: Hosp. Univ. Germans Trias I Pujol
city: Barcelona
country: Spain
facility: Hosp. Univ. Vall D Hebron
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Salamanca
country: Spain
facility: Hosp. Clinico Univ. de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital Universitario Doctor
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Basel
country: Switzerland
facility: University Hospital in Basel
state: Basel-Stadt (de)
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St. Gallen - Onkologie/Hämatologie
state: Sankt Gallen
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty - Hematology
state: Anatolia
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: İzmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi - Hematology
city: Dnipropetrovs'k
country: Ukraine
facility: KZ "Miska bahatoprofilna klinichna likarnia No4", hematolohi
state: Dnipropetrovs'ka Oblast'
city: Lviv
country: Ukraine
facility: Instytut patolohii krovi ta transfusiynoi medytsyny NAMN Ukr
state: L'vivs'ka Oblast'
city: Cherkasy
country: Ukraine
facility: KNP "Cherkaskyi oblasnyi onkolohichnyi dyspanser Cherkaskoi
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital - Clinical Haematology
state: Nottinghamshire
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Geron Corporation
name: Tymara Berry, MD
role: STUDY_DIRECTOR
References:
citation: Steensma DP, Fenaux P, Van Eygen K, Raza A, Santini V, Germing U, Font P, Diez-Campelo M, Thepot S, Vellenga E, Patnaik MM, Jang JH, Varsos H, Bussolari J, Rose E, Sherman L, Sun L, Wan Y, Dougherty S, Huang F, Feller F, Rizo A, Platzbecker U. Imetelstat Achieves Meaningful and Durable Transfusion Independence in High Transfusion-Burden Patients With Lower-Risk Myelodysplastic Syndromes in a Phase II Study. J Clin Oncol. 2021 Jan 1;39(1):48-56. doi: 10.1200/JCO.20.01895. Epub 2020 Oct 27.