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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04576156

Studienbeginn:
April 2021

Letztes Update:
30.06.2021

Wirkstoff:
Imetelstat, Best Available Therapy (BAT)

Indikation (Clinical Trials):
Primary Myelofibrosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Geron Corporation

Collaborator:
-

Studienleiter

Faye Feller
Study Director
Geron Corporation

Kontakt

Studienlocations
(3 von 147)

Universitätsk+B4:O4linikum Tüb
72076 Tübingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitätsklinikum Carl Gust
1307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
University Hospital RWTH Aache
52074 Aachen
GermanyNoch nicht rekrutierend» Google-Maps
St. Johannes Hospital
44137 Dortmund
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinik und Polikl
6120 Halle (Saale)
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
DeutschlandNoch nicht rekrutierend» Google-Maps
Klinikum Kempten-Oberallgaeu G
87439 Kempten
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Johannes Gutenberg Universität
55131 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Praxis für Hämatologie und Onk
66113 Saarbrücken
(Saarland)
GermanyNoch nicht rekrutierend» Google-Maps
University of California-San Diego/Moores UCSD Cancer Center
92093-1503 La Jolla
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UCLA david geffen school of medicine
90096 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
BRCR Medical Center Inc
33326 Plantation
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University of South Florida
33612 Tampa
United StatesNoch nicht rekrutierend» Google-Maps
Weill Cornell Medical College
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Gabrail Cancer Center
44718 Canton
United StatesNoch nicht rekrutierend» Google-Maps
Prairie Lakes Health Care System, Inc.
57201 Watertown
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The University of Texas MD
77030-4000 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Northwest Medical Specialties PLLC
98405 Tacoma
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Hospital Aleman
C118AAT Ciudad de Buenos Aires
ArgentinaNoch nicht rekrutierend» Google-Maps
Hospital Universitario Austral
B1629ODT Pilar
ArgentinaNoch nicht rekrutierend» Google-Maps
Clínica Los Arroyos
2000 Rosario
ArgentinaNoch nicht rekrutierend» Google-Maps
Sanatorio Allende
X5000JHQ Córdoba
ArgentinaNoch nicht rekrutierend» Google-Maps
Royal North Shore Hospital
2065 St Leonards
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Hobart Hospital
7000 Hobart
AustraliaNoch nicht rekrutierend» Google-Maps
Krankenhaus der Elisabethinen
4020 Linz
AustriaNoch nicht rekrutierend» Google-Maps
Centre Hospitalier de Jolimont
7100 Haine-Saint-Paul
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Zna - Campus Middelheim
2020 Antwerpen
BelgiumNoch nicht rekrutierend» Google-Maps
Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)
Jette
BelgiumNoch nicht rekrutierend» Google-Maps
Centro de oncologia Leonardo da Vinci
60135285 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Hospital das Clínicas UFG
74605 Goiânia
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Erasto Gaertner
81520-060 Curitiba
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Hospital de Clinicas de Porto Alegre - UFRGS
90035-903 Porto Alegre
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Associação Educadora São Carlos AESC - Hospital Mãe de Deus - Centro de Pesquisa
90880-480 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
CEPON Centro de Pesquisas Oncologicas SC
88034-000 Florianópolis
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Instituto de Educação, Pesquisa e Gestão em Saúde
01323000 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital A.C.Camargo Cancer Center - Clinical Oncology
São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
UMHAT "Dr. Georgi Stranski"
Pleven
BulgariaNoch nicht rekrutierend» Google-Maps
UMBAL Sveti Georgi
4002 Plovdiv
BulgariaNoch nicht rekrutierend» Google-Maps
Specialized Hospital for Active Therapy of Hematological dis
1756 Sofia
BulgariaNoch nicht rekrutierend» Google-Maps
Aarhus University Hospital - Hematology
8200 Aarhus
DenmarkNoch nicht rekrutierend» Google-Maps
Odense University Hospital - Hematology
DK-5000 C Odense
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Groupe Hospitalo-Universitaire
30029 Nimes Cedex 09
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CHU De Nantes - Hématologie C
44093 Nantes
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Centre Hospitalier Lyon
69310 Pierre-benite
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Centre Hospitalier Du Mans - Cancérologie Médicale
72037 Le Mans
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Hopital Avicenne - Hématologie Clinique
93009 Bobigny
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CHU - Hôpital Saint Louis - Centre D'Investigations Cliniq
75010 Paris
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Multi Profile Clinic Consilium
0179 Georgia
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LTD Israeli-Georgian Medical R
0112 Tbilisi
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M.Zodelava Hematology Center L
0112 Tbilisi
GeorgiaNoch nicht rekrutierend» Google-Maps
J.S.C."K.Eristavi National Cen
0159 Tbilisi
GeorgiaNoch nicht rekrutierend» Google-Maps
Ltd "Medinvest" Institute of H
186 Tbilisi
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Semmelweis Egyetem - III. sz.
1088 Budapest
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Dél-pesti Centrumkórház Ország
H-1097 Budapest
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Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András
4400 Nyíregyháza
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Fejer Megyei Szent Gyorgy Egye
8000 Székesfehérvár
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110029 New Delhi
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Sir Ganga Ram Hospital
110060 New Delhi
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Nirmal Hospital - Hematology
395002 Surat
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St. John's Medical College Hospital
560 034 Bangalore
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Fortis Hospital 154/9
560076 Bengaluru
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Fortis Memorial Research Institute
122002 Gurgaon
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All India Institute of Medical Sciences
751019 Bhubaneswar
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Nilratan Sircar Medical College
700014 Kolkata
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Assuta Ashdod University Hospi
7747629 Ashdod
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Barzilai Medical Center
78278 Ashkelon
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Kaplan Medical Center
7610001 Rehovot
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Shamir Medical Center (Assaf Harofeh)
7030000 Zerifin
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Western Galilee Hospital - Nahariya
22100 Nahariya
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Tel Aviv Sourasky Medical Cent
49372 Tel Aviv
IsraelNoch nicht rekrutierend» Google-Maps
Hadassah Medical Organization
9112001 Jerusalem
IsraelNoch nicht rekrutierend» Google-Maps
Bnai Zion Medical Center
31048 Haifa
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Arcispedale S.Anna - Ematologi
44124 Cona
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Istituto Clinico Humanitas Roz
20089 Rozzano
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AOU San Luigi Gonzaga
10043 Orbassano
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PO Civile SS.Antonio e Biagio
15121 Alessandria
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A.O.di Bologna Policl.S.Orsola
40138 Bologna
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Presidio Ospedaliero Garibaldi
95122 Catania
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Azienda Ospedaliero-Universita
50134 Firenze
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Clinica Ematologica, Univ. Deg
6- 16132 Genova
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Ospedale San Raffaele
20132 Milano
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ASST Grande Ospedale Metropoli
20162 Milano
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Azienda Ospedaliera San Gerard
20900 Monza
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Ospedale Civile S.Maria delle
48121 Ravenna
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Azienda Ospedaliera Bianchi-Me
89124 Reggio Calabria
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AUSL di Rimini Ospedale Inferm
47900 Rimini
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ASL Roma 2 - PO "S. Eugenio"
00144 Roma
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Policlinico Universitario Agos
00168 Roma
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Ospedale S.Bortolo, AULSS n.6
36100 Vicenza
ItalyNoch nicht rekrutierend» Google-Maps
Kyungpook National University
41944 Daegu
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital - Department of Internal
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital - Hematology and Oncology
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea
6591 Seongdong
Korea, Republic ofRekrutierend» Google-Maps
Severance Hospital, Yonsei Uni
3722 Seoul
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CHUC - Centro Hospitalar e Uni
3000-075 Coimbra
PortugalNoch nicht rekrutierend» Google-Maps
H. São Francisco Xavier-Centro
1495-005 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
H. Santa Maria. Centro Hospita
1649-035 Lisboa
PortugalNoch nicht rekrutierend» Google-Maps
MONIKI - Oncology
129110 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Novosibirsk State Medical Univ
630091 Novosibirsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Clinic of Hematology
410028 Saratov
Russian FederationNoch nicht rekrutierend» Google-Maps
Tula Regional Clinical Hospital
300053 Tula
Russian FederationNoch nicht rekrutierend» Google-Maps
Clinical oncological dispensar
644013 Omsk
Russian FederationNoch nicht rekrutierend» Google-Maps
Republican Hospital V.A. Baran
185019 Petrozavodsk
Russian FederationNoch nicht rekrutierend» Google-Maps
FGU "Russian Research Institute
191024 Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Saint-Petersburg State Medical
Saint Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
V.A. Almazov National Medical
197341 Saint-Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Singapore General Hospital
169608 Singapore
SingaporeNoch nicht rekrutierend» Google-Maps
National University Hospital
119228 Singapore
SingaporeNoch nicht rekrutierend» Google-Maps
Institut Català d'Oncologia-Ho
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario de Gran
35019 Las Palmas de Gran Canaria
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H.U. Ribera de Alzira
46600 Alzira
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Alicante Alicante
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H. San Pedro de Alcántara
10003 Cáceres
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ICO-Hospital Universitari de G
17007 Girona
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18014 Granada
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28040 Madrid
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Madrid Madrid
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29010 Málaga
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37007 Salamanca
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46017 Valencia
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50012 Zaragoza
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Universitaetsspital Zuerich
8091 Zurich
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Chang Gung Medical Foundation
613 Chiayi City
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China Medical University Hospital
404 Taichung City
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Taipei Veterans General Hospital
11217 Taipei
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Tri-Service General Hospital
11490 Taipei
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Chang Gung Medical Foundation
33305 Taoyuan
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34098 Istanbul
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34899 Istanbul
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ME16 9QQ Maidstone
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EC1A 7BE London
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SE1 9RT London
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OX3 9DS Oxford
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Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

- Refractory to JAK-inhibitor treatment as defined in either inclusion (i) or (ii):

(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 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 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])

- 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 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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - Baseline (Day 1) until End of Study (EOS) (approximately 3 years)):
Overall survival is defined as the time interval from randomization date to date of death from any cause.



Secondary outcome:

1. Symptom response rate (Time Frame - Baseline (Day 1), and at Week 24):
The proportion of participants achieving a ≥50% reduction in Total Symptom Score (TSS) measured at Week 24 compared to baseline

2. Progression-free survival (Time Frame - Baseline (Day 1) until End of Study (EOS) (approximately 3 years)):
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.

3. Spleen response rate (Time Frame - Baseline (Day 1), and at Week 24):
The proportion of participants who achieve a reduction in spleen volume of ≥ 35% from baseline at Week 24.

4. Complete remission (CR), partial remission (PR), clinical improvement (CI), spleen response, symptoms response, and anemia response per modified 2013 IWG-MRT criteria (Time Frame - Baseline (Day 1) until End of Treatment (approximately 3 years)):
The proportion of participants achieving CR or PR, CI, spleen response, symptom response, and anemia response per modified 2013 IWG-MRT criteria

5. Reduction in the degree of bone marrow fibrosis (Time Frame - Baseline (Day 1) until End of Treatment (approximately 3 years)):
Reduction in the degree of bone marrow fibrosis will be assessed.

6. Number of Participants with Adverse Events (Time Frame - Screening (Day -28 to -1) until End of Study (approximately 3 years)):
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

7. Assessment of Cmax (Time Frame - Day 1 of all cycles (each cycle is 28 days)):
Maximum Observed Plasma Concentration (Cmax).

8. European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) scores (Time Frame - Baseline to End of Study (approximately 3 years)):
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.

9. EuroQol-EQ-5D (EQ-5D-5L) questionnaire scores (Time Frame - Baseline to End of Study (approximately 3 years)):
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).

10. Assessment of AUC (Time Frame - Day 1 of all cycles (each cycle is 28 days)):
Area under the drug concentration-plasma time curve (AUC) from time zero to last measurable concentration

Studien-Arme

  • Experimental: Imetelstat
    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.
  • Active Comparator: Best Available Therapy (BAT)
    Participants will receive BAT (investigator-selected non-JAK-inhibitor treatment), until disease progression or unacceptable toxicity, treatment discontinuation or study end.

Geprüfte Regime

  • Imetelstat (GRN163L):
    Imetelstat will be given intravenously at 9.4 mg/kg every 21 days, until disease progression or unacceptable toxicity, treatment discontinuation or study end.
  • Best Available Therapy (BAT):
    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, and chemotherapy.

Quelle: ClinicalTrials.gov


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