Clinical trial NCT04576156: A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment
Official title: A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients With Intermediate-2 or High-risk Myelofibrosis (MF) Relapsed / Refractory (R/R) to Janus Kinase (JAK) Inhibitor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myelofibrosis
Keywords: Myeloproliferative neoplasms
Polycythemia
Thrombocythemia
Primary myelofibrosis
Janus Kinase-Inhibitor
Lead sponsor: Geron Corporation
Sponsor class: INDUSTRY
First posted: 2020-10-06
Enrollment: 320
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 the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.

Detailed description: This is a multicenter study with 2 arms, and will include 3 phases: a) screening phase of up to 28 days before randomization during which participants will complete a 14-day washout period from all prior therapies including JAK-inhibitor treatment, and the participant's eligibility will be reviewed; b) treatment phase, from randomization until study treatment (imetelstat or BAT) discontinuation; and c) post treatment follow-up phase, that begins when the participant discontinues treatment, and will continue until death, lost to follow-up, withdrawal of consent, or study end, whichever occurs first. Participants will be randomized (2:1) into 2 Arms (Arm A will receive imetelstat and Arm B will receive BAT).

Participants who meet progressive disease criteria and discontinue BAT, may crossover to receive imetelstat treatment after sponsor's approval.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary myelofibrosis according to the revised World Health Organization criteria or post-essential thrombocythemia-MF or post-polycythemia vera-MF according to the IWG-MRT criteria
* Dynamic International Prognostic Scoring System intermediate-2 or high-risk MF
* Relapsed/refractory to JAK-inhibitor treatment as defined in either inclusion (i), (ii) or (iii) and not eligible for allogeneic stem cell transplantation (ASCT) at screening:

  * (i) Treatment with JAK-inhibitor for \>= 6 months duration, including at least 2 months at an optimal dose as assessed by the investigator for that participant and at least one of the following:

    1. no decrease in spleen volume (\< 10% by MRI or CT) from the start of treatment with JAK-inhibitor
    2. no decrease in spleen size (\< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor
    3. no decrease in symptoms (\< 20% by Myelofibrosis Symptom Assessment Form \[MFSAF\] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor
    4. a score of at least 15 on TSS assessed using the MFSAF v4.0 during screening.
  * (ii) Treatment with JAK-inhibitor treatment for\>= 3 months duration with maximal doses (e.g., 20-25 mg twice daily ruxolitinib) for that participant and no decrease in spleen volume/size or symptoms as defined in inclusion criterion (i \[a, b, or c\]).
  * (iii) Following maximum tolerated doses of JAK inhibitor therapy for ≥3 months duration, having documented relapsed disease defined as either

    1. Increase in spleen volume from time of best response by 25% measured by MRI or CT, or
    2. Increase in spleen size by palpation, CT, or ultrasound

       * (b.i) For splenomegaly of 5-10 cm at the start of JAK inhibitor treatment, at least 100% increase in palpable spleen size from time of best response;
       * (b.ii) For splenomegaly of \> 10 cm at the start of JAK inhibitor treatment, at least 50% increase in palpable spleen size from time of best response;

AND not a candidate for further JAK inhibitor at screening per investigator.

* Measurable splenomegaly demonstrated by a palpable spleen measuring \>= 5 cm below the left costal margin or a spleen volume \>= 450 cm\^3 by MRI or CT
* Active symptoms of MF on the MFSAF v4.0 demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale)
* Hematology laboratory test values within the protocol defined limits
* Biochemical laboratory test values must be within protocol defined limits
* Eastern Cooperative Oncology Group Performance Status score of 0, 1, or 2
* Participants should follow protocol defined contraceptives procedures
* A woman of childbearing potential must have a negative serum or urine pregnancy test at screening

Exclusion Criteria:

* Peripheral blood blast count of \>= 10% or bone marrow blast count of \>=10%
* Known allergies, hypersensitivity, or intolerance to imetelstat or its excipients
* Prior treatment with imetelstat
* Any chemotherapy or MF directed therapy, including investigational drug regardless of class or mechanism of action, immunomodulatory or immunosuppressive therapy, corticosteroids greater than 30 mg/day prednisone or equivalent, and JAK-inhibitor treatment less than equal to 14 days prior to randomization
* Diagnosis or treatment for malignancy other than MF except:

  * Malignancy treated with curative intent and with no known active disease present for \>= 3 years before randomization
  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
  * Adequately treated cervical carcinoma in situ without evidence of disease
* Known history of human immunodeficiency virus or any uncontrolled active systemic infection requiring IV antibiotics
* Active systemic hepatitis infection requiring treatment (carriers of hepatitis virus are permitted to enter the study), or any known acute or chronic liver disease requiring treatment unless related to underlying hepatosplenomegaly due to MF
* Major surgery within 28 days prior to randomization
* Any life-threatening illness (e.g., coronavirus disease-2019), medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the imetelstat metabolism, or put the study outcomes at undue risk

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Baseline (Day 1) until End of Study (EOS) (approximately 3 years )]
Secondary outcomes:
measure: Symptom response rate
timeFrame: Baseline (Day 1), and at Week 24
measure: Progression-free survival
timeFrame: Baseline (Day 1) until End of Study (EOS) (approximately 3 years)
measure: Spleen response rate
timeFrame: Baseline (Day 1), and at Week 24
measure: Complete remission (CR), partial remission (PR), clinical improvement (CI), spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria
timeFrame: Baseline (Day 1) until End of Treatment (approximately 3 years)
measure: Reduction in the degree of bone marrow fibrosis
timeFrame: Baseline (Day 1) until End of Treatment (approximately 3 years)
measure: Number of Participants with Adverse Events
timeFrame: Screening (Day -28 to -1) until End of Study (approximately 3 years)
measure: Assessment of Cmax
timeFrame: Day 1 of all cycles (each cycle is 21 days)
measure: Assessment of Tmax
timeFrame: Day 1 of all cycles (each cycle is 21 days)
measure: Assessment of t1/2
timeFrame: Day 1 of all cycles (each cycle is 21 days)
measure: Assessment of AUC
timeFrame: Day 1 of all cycles (each cycle is 21 days)
measure: European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores
timeFrame: Baseline to End of Study (approximately 3 years)
measure: EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores
timeFrame: Baseline to End of Study (approximately 3 years)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California-San Diego/Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: New Haven
country: United States
facility: Smilow Cancer Center at YNHH
state: Connecticut
city: Clermont
country: United States
facility: Clermont Oncology
state: Florida
city: Plantation
country: United States
facility: BRCR Medical Center Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Goshen
country: United States
facility: Goshen Center for Cancer Care
state: Indiana
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Cancer Institute
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Rockville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Saint Louis
country: United States
facility: Mercy Health
state: Missouri
city: Springfield
country: United States
facility: Oncology Hematology Associates
state: Missouri
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: Reno
country: United States
facility: Cancer Care Specialists of Reno
state: Nevada
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of Central New York (HOACNY)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health
state: Ohio
city: Maumee
country: United States
facility: Taylor Cancer Research Center
state: Ohio
city: Salem
country: United States
facility: Oregon Oncology Specialists
state: Oregon
city: York
country: United States
facility: Cancer Care Associates of York
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Watertown
country: United States
facility: Prairie Lakes Health Care System, Inc.
state: South Dakota
city: Houston
country: United States
facility: The University of Texas MD
state: Texas
city: Ogden
country: United States
facility: Community Cancer Trials of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
city: Tacoma
country: United States
facility: Northwest Specialits
state: Washington
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Aleman
state: Buenos Aires
city: Rosario
country: Argentina
facility: Sanatorio de la Mujer
state: Santa Fe
city: Córdoba
country: Argentina
facility: Sanatorio Allende
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Wein
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
state: Burgenland
city: Linz
country: Austria
facility: Krankenhaus der Elisabethinen
state: Oberösterreich
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Gm
state: Oberösterreich
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Oberösterreich
city: Edegem
country: Belgium
facility: UZ Antwerpen
state: Antwerpen
city: Haine-Saint-Paul
country: Belgium
facility: Centre Hospitalier de Jolimont
state: Hainaut
city: Liege
country: Belgium
facility: CHU De Liège
state: Liège
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
state: Oost-Vlaanderen
city: Antwerpen
country: Belgium
facility: Zna - Campus Middelheim
city: Antwerpen
country: Belgium
facility: ZNA Stuyvenberg Antwerpen
city: Antwerpen
country: Belgium
facility: AZ Klina
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)
city: Fortaleza
country: Brazil
facility: Centro de oncologia Leonardo da Vinci
state: Ceará
city: Goiânia
country: Brazil
facility: Hospital das Clínicas UFG
state: Goiás
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - UFRGS
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: CEPON Centro de Pesquisas Oncologicas SC
city: São Paulo
country: Brazil
facility: Instituto de Educação, Pesquisa e Gestão em Saúde
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: São Paulo
country: Brazil
facility: Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho
city: São Paulo
country: Brazil
facility: Hospital A.C.Camargo Cancer Center - Clinical Oncology
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski"
city: Plovdiv
country: Bulgaria
facility: UMBAL Sveti Georgi
city: Sofia
country: Bulgaria
facility: Specialized Hospital for Active Therapy of Hematological dis
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A
state: Risaralda
city: Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A.
city: Floridablanca
country: Colombia
facility: FOSCAL
city: Odense
country: Denmark
facility: Odense University Hospital - Hematology
city: Nimes Cedex 09
country: France
facility: Institut de cancérologie du Gard - Hematologie clinique
state: Gard
city: Tours
country: France
facility: CHU Bretonneau
state: Indre-et-Loire
city: Paris
country: France
facility: Hopital Bicetre
state: Le Kremlin-Bicêtre
city: Haute-Vienne
country: France
facility: CHU de Limoges Dupuytren
state: Limoges
city: Nantes
country: France
facility: CHU De Nantes - HÃ©matologie C
state: Loire-Atlantique
city: Nice
country: France
facility: CHU de Nice - Hopital de l'Archet II - Pharmacie
state: Nice Cedex 3
city: Avignon cedex
country: France
facility: Hospital CENTRE HOSPITALIER AVIGNON
state: Provence-Alpes-Côte-d'Azur
city: Pierre-benite
country: France
facility: Centre Hospitalier Lyon
state: Rhône-Alpes
city: Loire
country: France
facility: CHU de Saint Etienne
state: Saint Priest En Jarez
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans - Cancérologie Médicale
state: Sarthe
city: Bobigny
country: France
facility: Hopital Avicenne - HÃ©matologie Clinique
state: Seine-Saint-Denis
city: Brest cedex
country: France
facility: CHRU Brest - Hôpital Morvan
city: Paris
country: France
facility: CHU - HÃ´pital Saint Louis - Centre D'Investigations Cliniq
city: Paris
country: France
facility: Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre
state: Île-de-France
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical R
city: Tbilisi
country: Georgia
facility: M.Zodelava Hematology Center L
city: Tbilisi
country: Georgia
facility: J.S.C."K.Eristavi National Cen
city: Tbilisi
country: Georgia
facility: Multi Profile Clinic Consilium
city: Tbilisi
country: Georgia
facility: Ltd "Medinvest - Institute of Hematology and Trans
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim - University of Heidelberg
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gust
state: Hamburg
city: Kempten
country: Germany
facility: Klinikum Kempten-Oberallgaeu GmbH
state: Rheinland-Pfalz
city: Halle (Saale)
country: Germany
facility: Martin-Luther-Universität Halle-Wittenberg
state: Sachsen-Anhalt
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AöR
state: Sachsen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig
state: Schleswig-Holstein
city: Budapest
country: Hungary
facility: Semmelweis Egyetem - III. sz.
city: Budapest
country: Hungary
facility: Dél-pesti Centrumkórház Ország
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz -
city: New Delhi
country: India
facility: All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)
state: Delhi
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Surat
country: India
facility: Nirmal Hospital - Hematology
state: Gujarat
city: Bangalore
country: India
facility: St. John's Medical College Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Fortis Hospital 154/9
state: Karnataka
city: Gurgaon
country: India
facility: Fortis Memorial Research Institute
state: New Delhi
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Orissa
city: Kolkata
country: India
facility: Nilratan Sircar Medical College
state: West Bengal
city: Hyderabad
country: India
facility: Narayana Hrudayalaya Hospital
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Center
city: Pune
country: India
facility: Sahyadri Specialty Hospital
city: Ashdod
country: Israel
facility: Assuta Ashdod University Hospi
state: HaDarom
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
state: HaDarom
city: Rehovot
country: Israel
facility: Kaplan Medical Center
state: HaMerkaz
city: Zerifin
country: Israel
facility: Shamir Medical Center (Assaf Harofeh)
state: HaMerkaz
city: Nahariya
country: Israel
facility: Western Galilee Hospital - Nahariya
state: HaZafon
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Cent
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
state: Yerushalayim
city: Beersheba
country: Israel
facility: Soroka Medical Center - Hematology Institute
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Carmel MC
city: Cona
country: Italy
facility: Arcispedale S.Anna - Ematologi
state: Ferrara
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas Roz
state: Milano
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: Torino
city: Alessandria
country: Italy
facility: PO Civile SS.Antonio e Biagio
city: Bologna
country: Italy
facility: A.O.di Bologna Policl.S.Orsola
city: Catania
country: Italy
facility: Presidio Ospedaliero Garibaldi
city: Firenze
country: Italy
facility: AOU Careggi
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Genova
country: Italy
facility: Clinica Ematologica, Univ. Deg
city: Meldola
country: Italy
facility: Irccs Irst
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropoli
city: Monza
country: Italy
facility: Azienda Ospedaliera San Gerard
city: Napoli
country: Italy
facility: AOU Federico II
city: Ravenna
country: Italy
facility: Ospedale Civile S.Maria delle Croci, AUSL Ravenna
city: Reggio Calabria
country: Italy
facility: Arcispedale S Maria Nuova, AO di Reggio Emilia
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Me
city: Rimini
country: Italy
facility: AUSL di Rimini Ospedale Infermi di Rimini
city: Roma
country: Italy
facility: ASL Roma 2 - PO "S. Eugenio"
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
city: Varese
country: Italy
facility: Ospedale di Circolo, PO Varese
city: Vicenza
country: Italy
facility: Ospedale S.Bortolo, AULSS n.6
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hos
state: Busan Gwang'yeogsi [Pusan-Kwangyokshi]
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan Gwang'yeogsi [Pusan-Kwangyokshi]
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital - Hematolog
state: Daegu Gwang'yeogsi [Taegu-Kwan]
city: Goyang-Si
country: Korea, Republic of
facility: National Cancer Institute Center for Cancer Research
state: Gyeonggido
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon Gwang'yeogsi [Inch'n-Kwangyokshi]
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital - Department of Internal
state: Seoul Teugbyeolsi [Seoul-T'ukp
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital - Hematology and Oncology
city: Seongdong
country: Korea, Republic of
facility: The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei Uni
city: Pulau Pinang
country: Malaysia
facility: Hospital Pulau Pinang
state: Georgetown
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah Johor Bahru
state: Johor
city: Kota Bharu
country: Malaysia
facility: Hospital Raja Perempuan Zainab II
state: Kelantan
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Ampang
country: Malaysia
facility: Hospital Ampang
state: Selangor
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl
state: Pomorskie
city: Piła
country: Poland
facility: Ars Medical Sp. z o.o.
state: Wielkopolskie
city: Skorzewo
country: Poland
facility: Centrum Medyczne Pratia Poznan
state: Wielkopolskie
city: Biała Podlaska
country: Poland
facility: Wojewodzki Szpital Specjalistyczny
city: Katowice
country: Poland
facility: Pratia Onkologia Katowice
state: Śląskie
city: Braga
country: Portugal
facility: CCA-Braga. Centro Clínico Académico - Hospital Braga
city: Coimbra
country: Portugal
facility: CHUC - Centro Hospitalar e Universitário de Coimbr
city: Lisboa
country: Portugal
facility: Instituto Português de Oncologia de Lisboa
city: Lisboa
country: Portugal
facility: Centro Clinico Fundacao Champalimaud
city: Lisboa
country: Portugal
facility: H. São Francisco Xavier-Centro
city: Lisboa
country: Portugal
facility: H. Santa Maria. Centro Hospita
city: Moscow
country: Russian Federation
facility: MONIKI - Oncology
state: Moskovskaya Oblast'
city: Novosibirsk
country: Russian Federation
facility: MUZ City Clinical Hospital # 2
state: Novosibirskaya Oblast'
city: Tula
country: Russian Federation
facility: Tula Regional Clinical Hospital
state: Tul'skaya Oblast'
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of Omsk Region
city: Saint Petersburg
country: Russian Federation
facility: V.A. Almazov National Medical Research Center
city: Saint-Petersburg
country: Russian Federation
facility: First Saint-Petersburg State Medical University n.
city: Saratov
country: Russian Federation
facility: GOU VPO Saratov State Medical University n.a. V.I.
city: Singapore
country: Singapore
facility: National University Cancer Institute (NCIS)
state: Central Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
state: Central Singapore
city: Badalona
country: Spain
facility: Institut Català d'Oncologia-Ho
state: Barcelona
city: Sabadell
country: Spain
facility: C.S. Parc Tauli
state: Barcelona
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran
state: Canarias
city: Málaga
country: Spain
facility: H. Comarcal Costa del Sol
state: Marbella
city: Alzira
country: Spain
facility: H.U. Ribera de Alzira
state: Valencia
city: Alicante
country: Spain
facility: H.G.U. Alicante
city: Cáceres
country: Spain
facility: H. San Pedro de Alcántara
city: Girona
country: Spain
facility: ICO-Hospital Universitari de G
city: Granada
country: Spain
facility: Hospital Universitario Virgen
city: Madrid
country: Spain
facility: Hospital Universitario Fundaci
city: Madrid
country: Spain
facility: Hospital U. 12 Octubre
city: Madrid
country: Spain
facility: H.U. La Paz
city: Málaga
country: Spain
facility: H.U.V. de la Victoria
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanco
city: Valencia
country: Spain
facility: Hospital Universitario Doctor
city: Zaragoza
country: Spain
facility: H. Quirón Zaragoza
city: Chiayi City
country: Taiwan
facility: Chang Gung Medical Foundation
state: Chiayi
city: Taichung City
country: Taiwan
facility: China Medical University Hospital - Hematology/Onc
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Mersin
country: Turkey
facility: Medical Park Mersin Hastanesi
state: Içel
city: Adapazarı
country: Turkey
facility: Sakarya Research and Training Hospital - Medical Oncology
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara University Medical Facu
city: Istanbul
country: Turkey
facility: Istanbul üniversitesi cerrahpaşa
city: Istanbul
country: Turkey
facility: Medipol Bagcilar Mega Hospital
city: Istanbul
country: Turkey
facility: Marmara university pendik training and research hospital
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi
city: Yenisehir/Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital
state: Kent
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas' Hospital
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals
Study officials:
affiliation: Geron Corporation
name: Faye Feller
role: STUDY_DIRECTOR
References:
citation: Mascarenhas J, Harrison CN, Kiladjian JJ, Komrokji RS, Koschmieder S, Vannucchi AM, Berry T, Redding D, Sherman L, Dougherty S, Peng L, Sun L, Huang F, Wan Y, Feller FM, Rizo A, Verstovsek S. Imetelstat in intermediate-2 or high-risk myelofibrosis refractory to JAK inhibitor: IMpactMF phase III study design. Future Oncol. 2022 Jul;18(22):2393-2402. doi: 10.2217/fon-2022-0235. Epub 2022 May 5.