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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

Primary Purpose

Myelofibrosis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Imetelstat
Best Available Therapy (BAT)
Sponsored by
Geron Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelofibrosis focused on measuring Myeloproliferative neoplasms, Polycythemia, Thrombocythemia, Primary myelofibrosis, Janus Kinase-Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Highlands Oncology
  • University of California-San Diego/Moores UCSD Cancer CenterRecruiting
  • Memorial Care
  • UCLA david geffen school of medicineRecruiting
  • Sharp HealthCare
  • The Oncology Institute - Innovative Clinical Research Institute (ICRI)
  • Hartford Healthcare
  • Smilow Cancer Center at YNHH
  • BRCR Medical Center IncRecruiting
  • University of South FloridaRecruiting
  • Fort Wayne Medical Oncology and Hematology
  • Goshen Center for Cancer Care
  • Beacon Health System
  • Maryland Oncology Hematology
  • Oncology Hematology Associates
  • Nebraska Cancer Specialists
  • Hematology-Oncology Associates of Central New York (HOACNY)
  • Icahn School of Medicine at Mount SinaiRecruiting
  • Duke University Medical CenterRecruiting
  • Aultman Medical Group
  • Gabrail Cancer CenterRecruiting
  • Ohio Health
  • Cancer Care Associates of York
  • Bon Secours (Greenville) - St. Francis Cancer Center
  • Sanford Health
  • Prairie Lakes Health Care System, Inc.Recruiting
  • The University of Texas MDRecruiting
  • Oncology Consultants
  • Community Cancer Trials of Utah
  • Utah Cancer Specialists
  • Northwest Medical Specialties PLLCRecruiting
  • Northwest Medical Specialties
  • Hospital AlemanRecruiting
  • Clínica Los Arroyos
  • Sanatorio de la MujerRecruiting
  • Sanatorio AllendeRecruiting
  • Royal North Shore HospitalRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Royal Hobart HospitalRecruiting
  • Epworth HealthcareRecruiting
  • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
  • Krankenhaus der ElisabethinenRecruiting
  • Kepler Universitätsklinikum GmRecruiting
  • Klinikum Wels-Grieskirchen GmbHRecruiting
  • UZ AntwerpenRecruiting
  • Centre Hospitalier de JolimontRecruiting
  • CHU De Liège
  • Universitair Ziekenhuis GentRecruiting
  • Zna - Campus Middelheim
  • ZNA Stuyvenberg Antwerpen
  • AZ KlinaRecruiting
  • Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)Recruiting
  • Centro de oncologia Leonardo da VinciRecruiting
  • Hospital das Clínicas UFGRecruiting
  • Hospital Erasto GaertnerRecruiting
  • Hospital de Clinicas de Porto Alegre - UFRGSRecruiting
  • Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDARecruiting
  • CEPON Centro de Pesquisas Oncologicas SCRecruiting
  • Instituto de Educação, Pesquisa e Gestão em SaúdeRecruiting
  • Hospital Israelita Albert EinsteinRecruiting
  • Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho
  • Hospital A.C.Camargo Cancer Center - Clinical OncologyRecruiting
  • UMHAT "Dr. Georgi Stranski"Recruiting
  • UMBAL Sveti GeorgiRecruiting
  • Specialized Hospital for Active Therapy of Hematological disRecruiting
  • Oncologos del Occidente S.ARecruiting
  • Hospital Pablo Tobon UribeRecruiting
  • Centro Medico Imbanaco de Cali S.A.Recruiting
  • FOSCALRecruiting
  • Odense University Hospital - HematologyRecruiting
  • Institut de cancérologie du Gard - Hematologie cliniqueRecruiting
  • CHU BretonneauRecruiting
  • Hopital BicetreRecruiting
  • CHU de Limoges DupuytrenRecruiting
  • CHU De Nantes - Hématologie CRecruiting
  • CHU de Nice - Hopital de l'Archet II - Pharmacie
  • Hospital CENTRE HOSPITALIER AVIGNONRecruiting
  • Centre Hospitalier LyonRecruiting
  • CHU de Saint Etienne
  • Centre Hospitalier Du Mans - Cancérologie MédicaleRecruiting
  • Hopital Avicenne - Hématologie CliniqueRecruiting
  • CHRU Brest - Hôpital MorvanRecruiting
  • CHU - Hôpital Saint Louis - Centre D'Investigations CliniqRecruiting
  • Hopital Cochin - Aphp Hôpitaux Universitaires Paris CentreRecruiting
  • LTD Israeli-Georgian Medical RRecruiting
  • M.Zodelava Hematology Center LRecruiting
  • J.S.C."K.Eristavi National CenRecruiting
  • Multi Profile Clinic ConsiliumRecruiting
  • Ltd "Medinvest" Institute of HRecruiting
  • Universitätsklinikum Mannheim - University of Heidelberg
  • Universitätsklinikum TübingenRecruiting
  • Universitätsklinikum Carl GustRecruiting
  • Klinikum Kempten-Oberallgaeu GmbHRecruiting
  • Martin-Luther-Universität Halle-WittenbergRecruiting
  • Universitätsklinikum Leipzig AöRRecruiting
  • Universitätsklinikum Schleswig
  • Semmelweis Egyetem - III. sz.Recruiting
  • Dél-pesti Centrumkórház OrszágRecruiting
  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa AndrásRecruiting
  • Fejer Megyei Szent Gyorgy EgyeRecruiting
  • All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)
  • Sir Ganga Ram HospitalRecruiting
  • Nirmal Hospital - HematologyRecruiting
  • St. John's Medical College HospitalRecruiting
  • Fortis Hospital 154/9Recruiting
  • Fortis Memorial Research InstituteRecruiting
  • All India Institute of Medical SciencesRecruiting
  • Nilratan Sircar Medical College
  • Narayana Hrudayalaya HospitalRecruiting
  • Deenanath Mangeshkar Hospital & Research CenterRecruiting
  • Sahyadri Specialty HospitalRecruiting
  • Assuta Ashdod University HospiRecruiting
  • Barzilai Medical CenterRecruiting
  • Kaplan Medical CenterRecruiting
  • Shamir Medical Center (Assaf Harofeh)Recruiting
  • Western Galilee Hospital - NahariyaRecruiting
  • Tel Aviv Sourasky Medical CentRecruiting
  • Hadassah Medical OrganizationRecruiting
  • Soroka Medical Center - Hematology Institute
  • Bnai Zion Medical CenterRecruiting
  • Carmel MCRecruiting
  • Arcispedale S.Anna - EmatologiRecruiting
  • Istituto Clinico Humanitas RozRecruiting
  • AOU San Luigi Gonzaga
  • PO Civile SS.Antonio e BiagioRecruiting
  • A.O.di Bologna Policl.S.OrsolaRecruiting
  • Presidio Ospedaliero GaribaldiRecruiting
  • AOU CareggiRecruiting
  • IRCCS Ospedale Policlinico San Martino
  • Clinica Ematologica, Univ. DegRecruiting
  • Irccs IrstRecruiting
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • Ospedale San RaffaeleRecruiting
  • ASST Grande Ospedale MetropoliRecruiting
  • Azienda Ospedaliera San GerardRecruiting
  • AOU Federico IIRecruiting
  • Ospedale Civile S.Maria delleRecruiting
  • Arcispedale S Maria Nuova, AO di Reggio EmiliaRecruiting
  • Azienda Ospedaliera Bianchi-MeRecruiting
  • AUSL di Rimini Ospedale InfermRecruiting
  • ASL Roma 2 - PO "S. Eugenio"Recruiting
  • Policlinico Universitario Agostino GemelliRecruiting
  • AOU Città della Salute e della Scienza di Torino
  • Ospedale di Circolo, PO Varese
  • Ospedale S.Bortolo, AULSS n.6Recruiting
  • Inje University Busan Paik HosRecruiting
  • Inje University Haeundae Paik Hospital
  • Kyungpook National University
  • National Cancer Institute Center for Cancer Research
  • Gachon University Gil Medical Center
  • Korea University Anam Hospital
  • Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul National University Hospital - Department of InternalRecruiting
  • Pusan National University Hospital - Hematology and OncologyRecruiting
  • The Catholic University of KoreaRecruiting
  • Severance Hospital, Yonsei UniRecruiting
  • Hospital Pulau PinangRecruiting
  • Hospital Sultanah Aminah Johor Bahru
  • Hospital Raja Perempuan Zainab IIRecruiting
  • Sarawak General HospitalRecruiting
  • Hospital AmpangRecruiting
  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w SlRecruiting
  • Ars Medical Sp. z o.o.Recruiting
  • Centrum Medyczne Pratia PoznanRecruiting
  • Wojewodzki Szpital Specjalistyczny
  • Pratia Onkologia KatowiceRecruiting
  • CCA-Braga. Centro Clínico Académico - Hospital BragaRecruiting
  • CHUC - Centro Hospitalar e UniRecruiting
  • Instituto Português de Oncologia de LisboaRecruiting
  • Centro Clinico Fundacao ChampalimaudRecruiting
  • H. São Francisco Xavier-CentroRecruiting
  • H. Santa Maria. Centro HospitaRecruiting
  • MONIKI - OncologyRecruiting
  • Moscow City Hospital n.a. Botkin
  • Novosibirsk State Medical UnivRecruiting
  • GOU VPO Saratov State Medical University n.a. V.I. RazumovskRecruiting
  • Tula Regional Clinical Hospital
  • Clinical oncological dispensarRecruiting
  • Saint-Petersburg State MedicalRecruiting
  • V.A. Almazov National MedicalRecruiting
  • National University Cancer Institute (NCIS)Recruiting
  • Singapore General HospitalRecruiting
  • Institut Català d'Oncologia-HoRecruiting
  • C.S. Parc TauliRecruiting
  • Hospital Universitario de GranRecruiting
  • H. Comarcal Costa del Sol
  • H.U. Ribera de AlziraRecruiting
  • H.G.U. AlicanteRecruiting
  • H. San Pedro de AlcántaraRecruiting
  • ICO-Hospital Universitari de GRecruiting
  • Hospital Universitario VirgenRecruiting
  • Hospital Universitario FundaciRecruiting
  • Hospital U. 12 OctubreRecruiting
  • H.U. La PazRecruiting
  • H.U.V. de la Victoria
  • Complejo Asistencial UniversitRecruiting
  • Hospital Universitario DoctorRecruiting
  • H. Quirón ZaragozaRecruiting
  • Chang Gung Medical FoundationRecruiting
  • China Medical University Hospital - Hematology/OncRecruiting
  • Taipei Veterans General Hospital
  • Tri-Service General HospitalRecruiting
  • Sakarya Research and Training Hospital - Medical Oncology
  • Gazi University Medical Faculty
  • Ankara University Medical FacuRecruiting
  • Istanbul Üniversitesi CerrahpaşaRecruiting
  • Medipol Bagcilar Mega Hospital
  • Marmara university pendik training and research hospitalRecruiting
  • Ege Universitesi Tip FakultesiRecruiting
  • Mersin University Medical Faculty
  • Maidstone HospitalRecruiting
  • St Bartholomew's HospitalRecruiting
  • Guys and St Thomas' HospitalRecruiting
  • Oxford University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imetelstat

Best Available Therapy (BAT)

Arm Description

Participants will receive imetelstat at 9.4 mg/kg intravenous (IV) every 21 days (±3 days), until disease progression or unacceptable toxicity, treatment discontinuation or study end.

Participants will receive BAT (investigator-selected non-JAK-inhibitor treatment), until disease progression or unacceptable toxicity, treatment discontinuation or study end. Participants on BAT who meet protocol-defined criteria for progressive disease may crossover to receive imetelstat treatment after sponsor's approval.

Outcomes

Primary Outcome Measures

Overall survival (OS)
Overall survival is defined as the time interval from randomization date to date of death from any cause.

Secondary Outcome Measures

Symptom response rate
The proportion of participants achieving a ≥50% reduction in Total Symptom Score (TSS) measured at Week 24 compared to baseline
Progression-free survival
Progression-free survival is defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria) or death from any cause, whichever occurs first.
Spleen response rate
The proportion of participants who achieve a reduction in spleen volume of ≥ 35% from baseline at Week 24.
Complete remission (CR), partial remission (PR), clinical improvement (CI), spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria
The proportion of participants achieving CR or PR, CI, spleen response, symptom response, and anemia response per modified 2013 IWG-MRT criteria.
Reduction in the degree of bone marrow fibrosis
Reduction in the degree of bone marrow fibrosis will be assessed.
Number of Participants with Adverse Events
Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment
Assessment of Cmax
Maximum Observed Plasma Concentration (Cmax).
Assessment of Tmax
Time to reach the maximum observed plasma concentration
Assessment of t1/2
Elimination half-life.
Assessment of AUC
Area under the drug concentration-plasma time curve (AUC) from time zero to last measurable concentration
European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores
Patient-reported outcomes including health-related quality of life, pain, and overall change in participant's health will be assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are transformed to a 0 to 100 scale. Higher scores indicated worse outcome.
EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores
EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).

Full Information

First Posted
September 18, 2020
Last Updated
October 4, 2023
Sponsor
Geron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04576156
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
April 27, 2026 (Anticipated)
Study Completion Date
April 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geron Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelofibrosis
Keywords
Myeloproliferative neoplasms, Polycythemia, Thrombocythemia, Primary myelofibrosis, Janus Kinase-Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imetelstat
Arm Type
Experimental
Arm Description
Participants will receive imetelstat at 9.4 mg/kg intravenous (IV) every 21 days (±3 days), until disease progression or unacceptable toxicity, treatment discontinuation or study end.
Arm Title
Best Available Therapy (BAT)
Arm Type
Active Comparator
Arm Description
Participants will receive BAT (investigator-selected non-JAK-inhibitor treatment), until disease progression or unacceptable toxicity, treatment discontinuation or study end. Participants on BAT who meet protocol-defined criteria for progressive disease may crossover to receive imetelstat treatment after sponsor's approval.
Intervention Type
Drug
Intervention Name(s)
Imetelstat
Other Intervention Name(s)
GRN163L
Intervention Description
Imetelstat will be given intravenously at 9.4 mg/kg every 21 days, until disease progression or unacceptable toxicity, treatment discontinuation or study end.
Intervention Type
Drug
Intervention Name(s)
Best Available Therapy (BAT)
Intervention Description
Non-JAK-inhibitor treatment will be given, which may include but is not limited to hydroxyurea, thalidomide or an analog of thalidomide, interferon, danazol, hypomethylating agents, chemotherapy or radiotherapy.
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival is defined as the time interval from randomization date to date of death from any cause.
Time Frame
Baseline (Day 1) until End of Study (EOS) (approximately 3 years )]
Secondary Outcome Measure Information:
Title
Symptom response rate
Description
The proportion of participants achieving a ≥50% reduction in Total Symptom Score (TSS) measured at Week 24 compared to baseline
Time Frame
Baseline (Day 1), and at Week 24
Title
Progression-free survival
Description
Progression-free survival is defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 International Working Group - Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria) or death from any cause, whichever occurs first.
Time Frame
Baseline (Day 1) until End of Study (EOS) (approximately 3 years)
Title
Spleen response rate
Description
The proportion of participants who achieve a reduction in spleen volume of ≥ 35% from baseline at Week 24.
Time Frame
Baseline (Day 1), and at Week 24
Title
Complete remission (CR), partial remission (PR), clinical improvement (CI), spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria
Description
The proportion of participants achieving CR or PR, CI, spleen response, symptom response, and anemia response per modified 2013 IWG-MRT criteria.
Time Frame
Baseline (Day 1) until End of Treatment (approximately 3 years)
Title
Reduction in the degree of bone marrow fibrosis
Description
Reduction in the degree of bone marrow fibrosis will be assessed.
Time Frame
Baseline (Day 1) until End of Treatment (approximately 3 years)
Title
Number of Participants with Adverse Events
Description
Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment
Time Frame
Screening (Day -28 to -1) until End of Study (approximately 3 years)
Title
Assessment of Cmax
Description
Maximum Observed Plasma Concentration (Cmax).
Time Frame
Day 1 of all cycles (each cycle is 21 days)
Title
Assessment of Tmax
Description
Time to reach the maximum observed plasma concentration
Time Frame
Day 1 of all cycles (each cycle is 21 days)
Title
Assessment of t1/2
Description
Elimination half-life.
Time Frame
Day 1 of all cycles (each cycle is 21 days)
Title
Assessment of AUC
Description
Area under the drug concentration-plasma time curve (AUC) from time zero to last measurable concentration
Time Frame
Day 1 of all cycles (each cycle is 21 days)
Title
European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores
Description
Patient-reported outcomes including health-related quality of life, pain, and overall change in participant's health will be assessed using the EORTC QLQ-C30. The EORTC QLQ-C30 includes 30 items resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 Global Health Status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Scores are transformed to a 0 to 100 scale. Higher scores indicated worse outcome.
Time Frame
Baseline to End of Study (approximately 3 years)
Title
EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores
Description
EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame
Baseline to End of Study (approximately 3 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: no decrease in spleen volume (< 10% by MRI or CT) from the start of treatment with JAK-inhibitor no decrease in spleen size (< 30% by palpation or length by imaging) from the start of treatment with JAK-inhibitor no decrease in symptoms (< 20% by Myelofibrosis Symptom Assessment Form [MFSAF] or myeloproliferative neoplasm SAF) from the start of treatment with JAK-inhibitor 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 Increase in spleen volume from time of best response by 25% measured by MRI or CT, or 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tymara Berry, MD
Phone
650-473-7793
Email
myf3001-info@Geron.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Redding
Email
myf3001-info@Geron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faye Feller
Organizational Affiliation
Geron Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Highlands Oncology
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California-San Diego/Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-1503
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Care
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UCLA david geffen school of medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90096
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharp HealthCare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
The Oncology Institute - Innovative Clinical Research Institute (ICRI)
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hartford Healthcare
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Smilow Cancer Center at YNHH
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
BRCR Medical Center Inc
City
Plantation
State/Province
Florida
ZIP/Postal Code
33326
Country
United States
Individual Site Status
Recruiting
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Wayne Medical Oncology and Hematology
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Beacon Health System
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Maryland Oncology Hematology
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology Associates
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hematology-Oncology Associates of Central New York (HOACNY)
City
East Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Aultman Medical Group
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cancer Care Associates of York
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Bon Secours (Greenville) - St. Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Prairie Lakes Health Care System, Inc.
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4000
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Community Cancer Trials of Utah
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Northwest Medical Specialties PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Hospital Aleman
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C118AAT
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clínica Los Arroyos
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Sanatorio de la Mujer
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000ORE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende
City
Córdoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4011
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Healthcare
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Name
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
City
Wein
State/Province
Burgenland
ZIP/Postal Code
1130
Country
Austria
Individual Site Status
Not yet recruiting
Facility Name
Krankenhaus der Elisabethinen
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Kepler Universitätsklinikum Gm
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4021
Country
Austria
Individual Site Status
Recruiting
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
State/Province
Oberösterreich
ZIP/Postal Code
4600
Country
Austria
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de Jolimont
City
Haine-Saint-Paul
State/Province
Hainaut
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU De Liège
City
Liege
State/Province
Liège
ZIP/Postal Code
04000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Zna - Campus Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
ZNA Stuyvenberg Antwerpen
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Individual Site Status
Withdrawn
Facility Name
AZ Klina
City
Antwerpen
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)
City
Jette
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Centro de oncologia Leonardo da Vinci
City
Fortaleza
State/Province
Ceará
ZIP/Postal Code
60135285
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital das Clínicas UFG
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74605
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital de Clinicas de Porto Alegre - UFRGS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470340
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CEPON Centro de Pesquisas Oncologicas SC
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Educação, Pesquisa e Gestão em Saúde
City
São Paulo
ZIP/Postal Code
01323000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05651-901
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho
City
São Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Hospital A.C.Camargo Cancer Center - Clinical Oncology
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
UMHAT "Dr. Georgi Stranski"
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMBAL Sveti Georgi
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Therapy of Hematological dis
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Oncologos del Occidente S.A
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660000
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Hospital Pablo Tobon Uribe
City
Antioquia
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro Medico Imbanaco de Cali S.A.
City
Cali
ZIP/Postal Code
420076
Country
Colombia
Individual Site Status
Recruiting
Facility Name
FOSCAL
City
Floridablanca
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Odense University Hospital - Hematology
City
Odense
ZIP/Postal Code
DK-5000 C
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Institut de cancérologie du Gard - Hematologie clinique
City
Nimes Cedex 09
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Bretonneau
City
Tours
State/Province
Indre-et-Loire
ZIP/Postal Code
37044
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Bicetre
City
Paris
State/Province
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Limoges Dupuytren
City
Haute-Vienne
State/Province
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Name
CHU De Nantes - Hématologie C
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nice - Hopital de l'Archet II - Pharmacie
City
Nice
State/Province
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hospital CENTRE HOSPITALIER AVIGNON
City
Avignon cedex
State/Province
Provence-Alpes-Côte-d'Azur
ZIP/Postal Code
84902
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon
City
Pierre-benite
State/Province
Rhône-Alpes
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Saint Etienne
City
Loire
State/Province
Saint Priest En Jarez
ZIP/Postal Code
42271
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Du Mans - Cancérologie Médicale
City
Le Mans
State/Province
Sarthe
ZIP/Postal Code
72037
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Avicenne - Hématologie Clinique
City
Bobigny
State/Province
Seine-Saint-Denis
ZIP/Postal Code
93009
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Brest - Hôpital Morvan
City
Brest cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Name
CHU - Hôpital Saint Louis - Centre D'Investigations Cliniq
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre
City
Paris
State/Province
Île-de-France
ZIP/Postal Code
75679
Country
France
Individual Site Status
Recruiting
Facility Name
LTD Israeli-Georgian Medical R
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
M.Zodelava Hematology Center L
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
J.S.C."K.Eristavi National Cen
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Multi Profile Clinic Consilium
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Ltd "Medinvest" Institute of H
City
Tbilisi
ZIP/Postal Code
186
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Mannheim - University of Heidelberg
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68167
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gust
City
Dresden
State/Province
Hamburg
ZIP/Postal Code
1307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinikum Kempten-Oberallgaeu GmbH
City
Kempten
State/Province
Rheinland-Pfalz
ZIP/Postal Code
87439
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin-Luther-Universität Halle-Wittenberg
City
Halle (Saale)
State/Province
Sachsen-Anhalt
ZIP/Postal Code
6120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Leipzig AöR
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Schleswig
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Semmelweis Egyetem - III. sz.
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Dél-pesti Centrumkórház Ország
City
Budapest
ZIP/Postal Code
H-1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejer Megyei Szent Gyorgy Egye
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Suspended
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Nirmal Hospital - Hematology
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
St. John's Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Individual Site Status
Recruiting
Facility Name
Fortis Hospital 154/9
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560076
Country
India
Individual Site Status
Recruiting
Facility Name
Fortis Memorial Research Institute
City
Gurgaon
State/Province
New Delhi
ZIP/Postal Code
122002
Country
India
Individual Site Status
Recruiting
Facility Name
All India Institute of Medical Sciences
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751019
Country
India
Individual Site Status
Recruiting
Facility Name
Nilratan Sircar Medical College
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700014
Country
India
Individual Site Status
Suspended
Facility Name
Narayana Hrudayalaya Hospital
City
Hyderabad
ZIP/Postal Code
560099
Country
India
Individual Site Status
Recruiting
Facility Name
Deenanath Mangeshkar Hospital & Research Center
City
Pune
ZIP/Postal Code
411004
Country
India
Individual Site Status
Recruiting
Facility Name
Sahyadri Specialty Hospital
City
Pune
Country
India
Individual Site Status
Recruiting
Facility Name
Assuta Ashdod University Hospi
City
Ashdod
State/Province
HaDarom
ZIP/Postal Code
7747629
Country
Israel
Individual Site Status
Recruiting
Facility Name
Barzilai Medical Center
City
Ashkelon
State/Province
HaDarom
ZIP/Postal Code
78278
Country
Israel
Individual Site Status
Recruiting
Facility Name
Kaplan Medical Center
City
Rehovot
State/Province
HaMerkaz
ZIP/Postal Code
7610001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Shamir Medical Center (Assaf Harofeh)
City
Zerifin
State/Province
HaMerkaz
ZIP/Postal Code
7030000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Western Galilee Hospital - Nahariya
City
Nahariya
State/Province
HaZafon
ZIP/Postal Code
22100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Cent
City
Tel Aviv
State/Province
Tel-Aviv
ZIP/Postal Code
49372
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Organization
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Individual Site Status
Recruiting
Facility Name
Soroka Medical Center - Hematology Institute
City
Beersheba
ZIP/Postal Code
84101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel MC
City
Haifa
ZIP/Postal Code
3436212
Country
Israel
Individual Site Status
Recruiting
Facility Name
Arcispedale S.Anna - Ematologi
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Clinico Humanitas Roz
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU San Luigi Gonzaga
City
Orbassano
State/Province
Torino
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
PO Civile SS.Antonio e Biagio
City
Alessandria
ZIP/Postal Code
15121
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.di Bologna Policl.S.Orsola
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero Garibaldi
City
Catania
ZIP/Postal Code
95122
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Clinica Ematologica, Univ. Deg
City
Genova
ZIP/Postal Code
6- 16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs Irst
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropoli
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera San Gerard
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Federico II
City
Napoli
ZIP/Postal Code
80122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Civile S.Maria delle
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale S Maria Nuova, AO di Reggio Emilia
City
Reggio Calabria
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Bianchi-Me
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
Individual Site Status
Recruiting
Facility Name
AUSL di Rimini Ospedale Inferm
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASL Roma 2 - PO "S. Eugenio"
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale di Circolo, PO Varese
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Ospedale S.Bortolo, AULSS n.6
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Inje University Busan Paik Hos
City
Busan
State/Province
Busan Gwang'yeogsi [Pusan-Kwangyokshi]
ZIP/Postal Code
47392
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
State/Province
Busan Gwang'yeogsi [Pusan-Kwangyokshi]
ZIP/Postal Code
48108
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Kyungpook National University
City
Daegu
State/Province
Daegu Gwang'yeogsi [Taegu-Kwan]
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
National Cancer Institute Center for Cancer Research
City
Goyang-Si
State/Province
Gyeonggido
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Incheon Gwang'yeogsi [Inch'n-Kwangyokshi]
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
06273
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukpyolshi]
ZIP/Postal Code
6351
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National University Hospital - Department of Internal
City
Seoul
State/Province
Seoul Teugbyeolsi [Seoul-T'ukp
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital - Hematology and Oncology
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea
City
Seongdong
ZIP/Postal Code
6591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei Uni
City
Seoul
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Hospital Pulau Pinang
City
Pulau Pinang
State/Province
Georgetown
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Sultanah Aminah Johor Bahru
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Name
Hospital Raja Perempuan Zainab II
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
15586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Sarawak General Hospital
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Ampang
City
Ampang
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Ars Medical Sp. z o.o.
City
Piła
State/Province
Wielkopolskie
ZIP/Postal Code
64-920
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
State/Province
Wielkopolskie
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny
City
Biała Podlaska
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
CCA-Braga. Centro Clínico Académico - Hospital Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
CHUC - Centro Hospitalar e Uni
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Instituto Português de Oncologia de Lisboa
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Clinico Fundacao Champalimaud
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Individual Site Status
Recruiting
Facility Name
H. São Francisco Xavier-Centro
City
Lisboa
ZIP/Postal Code
1495-005
Country
Portugal
Individual Site Status
Recruiting
Facility Name
H. Santa Maria. Centro Hospita
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
MONIKI - Oncology
City
Moscow
State/Province
Moskovskaya Oblast'
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Moscow City Hospital n.a. Botkin
City
Moscow
State/Province
Moskva
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Novosibirsk State Medical Univ
City
Novosibirsk
State/Province
Novosibirskaya Oblast'
ZIP/Postal Code
630091
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
GOU VPO Saratov State Medical University n.a. V.I. Razumovsk
City
Saratov
State/Province
Saratovskaya Oblast'
ZIP/Postal Code
410012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Tula Regional Clinical Hospital
City
Tula
State/Province
Tul'skaya Oblast'
ZIP/Postal Code
300053
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Clinical oncological dispensar
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Saint-Petersburg State Medical
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
V.A. Almazov National Medical
City
Saint-Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
National University Cancer Institute (NCIS)
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore General Hospital
City
Singapore
State/Province
Central Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia-Ho
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
C.S. Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Gran
City
Las Palmas de Gran Canaria
State/Province
Canarias
ZIP/Postal Code
35019
Country
Spain
Individual Site Status
Recruiting
Facility Name
H. Comarcal Costa del Sol
City
Málaga
State/Province
Marbella
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
H.U. Ribera de Alzira
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Individual Site Status
Recruiting
Facility Name
H.G.U. Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
H. San Pedro de Alcántara
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
ICO-Hospital Universitari de G
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen
City
Granada
ZIP/Postal Code
18014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundaci
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital U. 12 Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
H.U. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
H.U.V. de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Complejo Asistencial Universit
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Doctor
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Individual Site Status
Recruiting
Facility Name
H. Quirón Zaragoza
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation
City
Chiayi City
State/Province
Chiayi
ZIP/Postal Code
613
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital - Hematology/Onc
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Sakarya Research and Training Hospital - Medical Oncology
City
Adapazarı
ZIP/Postal Code
54100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Gazi University Medical Faculty
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Ankara University Medical Facu
City
Ankara
ZIP/Postal Code
6590
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul Üniversitesi Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medipol Bagcilar Mega Hospital
City
Istanbul
ZIP/Postal Code
34214
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Marmara university pendik training and research hospital
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege Universitesi Tip Fakultesi
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Mersin University Medical Faculty
City
Yenisehir/Mersin
ZIP/Postal Code
33110
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St Bartholomew's Hospital
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Guys and St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Oxford University Hospitals
City
Oxford
ZIP/Postal Code
OX3 9DS
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35510486
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.
Results Reference
derived

Learn more about this trial

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

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