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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:
29.02.2024

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 217)

Universitätsklinikum Mannheim - University of Heidelberg
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Viszeralonkologisches Zentrum Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
Universitätsklinikum Carl Gust
1307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Klinikum Kempten-Oberallgaeu GmbH
87439 Kempten
(Bayern)
GermanyRekrutierend» Google-Maps
Martin-Luther-Universität Halle-Wittenberg
6120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Universitätsklinikum Leipzig AöR
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Darmkrebszentrum am Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
23562 Lübeck
DeutschlandZurückgezogen» Google-Maps
Highlands Oncology
72703 Fayetteville
United StatesNoch nicht rekrutierend» Google-Maps
University of California-San Diego/Moores UCSD Cancer Center
92093-1503 La Jolla
United StatesRekrutierend» Google-Maps
Memorial Care
90806 Long Beach
United StatesNoch nicht rekrutierend» Google-Maps
UCLA david geffen school of medicine
90096 Los Angeles
United StatesRekrutierend» Google-Maps
Sharp HealthCare
92123 San Diego
United StatesNoch nicht rekrutierend» Google-Maps
The Oncology Institute - Innovative Clinical Research Institute (ICRI)
90602 Whittier
United StatesNoch nicht rekrutierend» Google-Maps
Hartford Healthcare
06102 Hartford
United StatesNoch nicht rekrutierend» Google-Maps
Smilow Cancer Center at YNHH
06511 New Haven
United StatesNoch nicht rekrutierend» Google-Maps
BRCR Medical Center Inc
33326 Plantation
United StatesRekrutierend» Google-Maps
University of South Florida
33612 Tampa
United StatesRekrutierend» Google-Maps
Fort Wayne Medical Oncology and Hematology
46804 Fort Wayne
United StatesNoch nicht rekrutierend» Google-Maps
Goshen Center for Cancer Care
46526 Goshen
United StatesNoch nicht rekrutierend» Google-Maps
Beacon Health System
46601 South Bend
United StatesNoch nicht rekrutierend» Google-Maps
Norton Cancer Institute
40207 Louisville
United StatesNoch nicht rekrutierend» Google-Maps
Maryland Oncology Hematology
20850 Rockville
United StatesNoch nicht rekrutierend» Google-Maps
Oncology Hematology Associates
65807 Springfield
United StatesNoch nicht rekrutierend» Google-Maps
Nebraska Cancer Specialists
68130 Omaha
United StatesNoch nicht rekrutierend» Google-Maps
Hematology-Oncology Associates of Central New York (HOACNY)
13057 East Syracuse
United StatesNoch nicht rekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai
10029 New York
United StatesRekrutierend» Google-Maps
Duke University Medical Center
27710 Durham
United StatesRekrutierend» Google-Maps
Aultman Medical Group
44708 Canton
United StatesNoch nicht rekrutierend» Google-Maps
Ohio Health
43214 Columbus
United StatesNoch nicht rekrutierend» Google-Maps
Cancer Care Associates of York
17403 York
United StatesNoch nicht rekrutierend» Google-Maps
Bon Secours (Greenville) - St. Francis Cancer Center
29607 Greenville
United StatesNoch nicht rekrutierend» Google-Maps
Sanford Health
57104 Sioux Falls
United StatesNoch nicht rekrutierend» Google-Maps
Prairie Lakes Health Care System, Inc.
57201 Watertown
United StatesRekrutierend» Google-Maps
The University of Texas MD
77030-4000 Houston
United StatesRekrutierend» Google-Maps
Oncology Consultants
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Community Cancer Trials of Utah
84405 Ogden
United StatesNoch nicht rekrutierend» Google-Maps
Utah Cancer Specialists
84106 Salt Lake City
United StatesNoch nicht rekrutierend» Google-Maps
Northwest Medical Specialties PLLC
98405 Tacoma
United StatesZurückgezogen» Google-Maps
Hospital Aleman
C118AAT Ciudad de Buenos Aires
ArgentinaRekrutierend» Google-Maps
Royal North Shore Hospital
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Royal Brisbane and Women's Hospital
4011 Herston
AustraliaRekrutierend» Google-Maps
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
1130 Wein
AustriaNoch nicht rekrutierend» Google-Maps
Centre Hospitalier de Jolimont
7100 Haine-Saint-Paul
BelgiumRekrutierend» Google-Maps
ZNA Stuyvenberg Antwerpen
2060 Antwerpen
BelgiumZurückgezogen» Google-Maps
Universitair Ziekenhuis Brussel - Myeloom Centrum Brussel (MCB)
Jette
BelgiumRekrutierend» Google-Maps
Centro de oncologia Leonardo da Vinci
60135285 Fortaleza
BrazilRekrutierend» Google-Maps
Hospital Erasto Gaertner
81520-060 Curitiba
BrazilRekrutierend» Google-Maps
Hospital de Clinicas de Porto Alegre - UFRGS
90035-903 Porto Alegre
BrazilRekrutierend» Google-Maps
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa LTDA
90470340 Porto Alegre
BrazilRekrutierend» Google-Maps
CEPON Centro de Pesquisas Oncologicas SC
88034-000 Florianópolis
BrazilRekrutierend» Google-Maps
Instituto de Educação, Pesquisa e Gestão em Saúde
01323000 São Paulo
BrazilRekrutierend» Google-Maps
Hospital Israelita Albert Einstein
05651-901 São Paulo
BrazilRekrutierend» Google-Maps
Fundacao Doutor Amaral Carvalho / Hospital Amaral Carvalho
17210-120 São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Hospital A.C.Camargo Cancer Center - Clinical Oncology
São Paulo
BrazilRekrutierend» Google-Maps
Specialized Hospital for Active Therapy of Hematological dis
1756 Sofia
BulgariaRekrutierend» Google-Maps
Oncologos del Occidente S.A
660000 Pereira
ColombiaRekrutierend» Google-Maps
Centro Medico Imbanaco de Cali S.A.
420076 Cali
ColombiaRekrutierend» Google-Maps
Odense University Hospital - Hematology
DK-5000 C Odense
DenmarkRekrutierend» Google-Maps
Institut de cancérologie du Gard - Hematologie clinique
30029 Nimes Cedex 09
FranceRekrutierend» Google-Maps
CHU de Limoges Dupuytren
87042 Haute-Vienne
FranceRekrutierend» Google-Maps
CHU De Nantes - Hématologie C
44093 Nantes
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CHU de Nice - Hopital de l'Archet II - Pharmacie
06202 Nice
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Hospital CENTRE HOSPITALIER AVIGNON
84902 Avignon cedex
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Centre Hospitalier Lyon
69310 Pierre-benite
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CHU de Saint Etienne
42271 Loire
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Du Mans - Cancérologie Médicale
72037 Le Mans
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Hopital Avicenne - Hématologie Clinique
93009 Bobigny
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CHRU Brest - Hôpital Morvan
29609 Brest cedex
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CHU - Hôpital Saint Louis - Centre D'Investigations Cliniq
75010 Paris
FranceRekrutierend» Google-Maps
Hopital Cochin - Aphp Hôpitaux Universitaires Paris Centre
75679 Paris
FranceRekrutierend» Google-Maps
LTD Israeli-Georgian Medical R
0112 Tbilisi
GeorgiaRekrutierend» Google-Maps
M.Zodelava Hematology Center L
0112 Tbilisi
GeorgiaZurückgezogen» Google-Maps
J.S.C."K.Eristavi National Cen
0159 Tbilisi
GeorgiaRekrutierend» Google-Maps
Multi Profile Clinic Consilium
0179 Tbilisi
GeorgiaRekrutierend» Google-Maps
Ltd "Medinvest" Institute of H
186 Tbilisi
GeorgiaRekrutierend» Google-Maps
Semmelweis Egyetem - III. sz.
1088 Budapest
HungaryZurückgezogen» Google-Maps
Dél-pesti Centrumkórház Ország
H-1097 Budapest
HungaryRekrutierend» Google-Maps
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András
4400 Nyíregyháza
HungaryRekrutierend» Google-Maps
Fejer Megyei Szent Gyorgy Egye
8000 Székesfehérvár
HungaryRekrutierend» Google-Maps
All India Institute of Medical Sciences, Dept. of Hematology, New Delhi (All India Institute Of Medical Sciences)
110029 New Delhi
IndiaSchwebend» Google-Maps
St. John's Medical College Hospital
560 034 Bangalore
IndiaRekrutierend» Google-Maps
Fortis Memorial Research Institute
122002 Gurgaon
IndiaRekrutierend» Google-Maps
All India Institute of Medical Sciences
751019 Bhubaneswar
IndiaRekrutierend» Google-Maps
Narayana Hrudayalaya Hospital
560099 Hyderabad
IndiaRekrutierend» Google-Maps
Deenanath Mangeshkar Hospital & Research Center
411004 Pune
IndiaRekrutierend» Google-Maps
Assuta Ashdod University Hospi
7747629 Ashdod
IsraelRekrutierend» Google-Maps
Shamir Medical Center (Assaf Harofeh)
7030000 Zerifin
IsraelRekrutierend» Google-Maps
Western Galilee Hospital - Nahariya
22100 Nahariya
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Cent
49372 Tel Aviv
IsraelZurückgezogen» Google-Maps
Hadassah Medical Organization
9112001 Jerusalem
IsraelRekrutierend» Google-Maps
Soroka Medical Center - Hematology Institute
84101 Beersheba
IsraelNoch nicht rekrutierend» Google-Maps
Istituto Clinico Humanitas Roz
20089 Rozzano
ItalyRekrutierend» Google-Maps
PO Civile SS.Antonio e Biagio
15121 Alessandria
ItalyRekrutierend» Google-Maps
A.O.di Bologna Policl.S.Orsola
40138 Bologna
ItalyRekrutierend» Google-Maps
Presidio Ospedaliero Garibaldi
95122 Catania
ItalyRekrutierend» Google-Maps
IRCCS Ospedale Policlinico San Martino
16132 Genova
ItalyNoch nicht rekrutierend» Google-Maps
Clinica Ematologica, Univ. Deg
6- 16132 Genova
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
20122 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Arcispedale S Maria Nuova, AO di Reggio Emilia
42123 Reggio Calabria
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Bianchi-Me
89124 Reggio Calabria
ItalyRekrutierend» Google-Maps
Policlinico Universitario Agostino Gemelli
00168 Roma
ItalyRekrutierend» Google-Maps
AOU Città della Salute e della Scienza di Torino
10126 Torino
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale di Circolo, PO Varese
21100 Varese
ItalyNoch nicht rekrutierend» Google-Maps
Inje University Busan Paik Hos
47392 Busan
Korea, Republic ofRekrutierend» Google-Maps
Inje University Haeundae Paik Hospital
48108 Busan
Korea, Republic ofRekrutierend» Google-Maps
Kyungpook National University
41944 Daegu
Korea, Republic ofZurückgezogen» Google-Maps
National Cancer Institute Center for Cancer Research
10408 Goyang-Si
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Gangnam Severance Hospital, Yonsei University Health System
06273 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Korea University Guro Hospital
08308 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
6351 Seoul
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
Korea, Republic ofRekrutierend» Google-Maps
Hospital Sultanah Aminah Johor Bahru
80000 Johor Bahru
MalaysiaRekrutierend» Google-Maps
Hospital Raja Perempuan Zainab II
15586 Kota Bharu
MalaysiaRekrutierend» Google-Maps
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Sl
76-200 Slupsk
PolandZurückgezogen» Google-Maps
Centrum Medyczne Pratia Poznan
60-185 Skorzewo
PolandRekrutierend» Google-Maps
Wojewodzki Szpital Specjalistyczny
21-500 Biała Podlaska
PolandNoch nicht rekrutierend» Google-Maps
CCA-Braga. Centro Clínico Académico - Hospital Braga
4710-243 Braga
PortugalRekrutierend» Google-Maps
CHUC - Centro Hospitalar e Uni
3000-075 Coimbra
PortugalRekrutierend» Google-Maps
Instituto Português de Oncologia de Lisboa
1099-023 Lisboa
PortugalRekrutierend» Google-Maps
Centro Clinico Fundacao Champalimaud
1400-038 Lisboa
PortugalRekrutierend» Google-Maps
H. São Francisco Xavier-Centro
1495-005 Lisboa
PortugalRekrutierend» Google-Maps
H. Santa Maria. Centro Hospita
1649-035 Lisboa
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia do Porto
4200-072 Porto
PortugalNoch nicht rekrutierend» Google-Maps
MONIKI - Oncology
129110 Moscow
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Moscow City Hospital n.a. Botkin
125284 Moscow
Russian FederationZurückgezogen» Google-Maps
MUZ City Clinical Hospital # 2
630051 Novosibirsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
Novosibirsk State Medical Univ
630091 Novosibirsk
Russian FederationRekrutierend» Google-Maps
Tula Regional Clinical Hospital
300053 Tula
Russian FederationAbgebrochen» Google-Maps
Budgetary Healthcare Institution of Omsk Region
644013 Omsk
Russian FederationAktiv, nicht rekrutierend» Google-Maps
V.A. Almazov National Medical Research Center
197341 Saint Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
First Saint-Petersburg State Medical University n.
197022 Saint-Petersburg
Russian FederationAktiv, nicht rekrutierend» Google-Maps
GOU VPO Saratov State Medical University n.a. V.I.
410012 Saratov
Russian FederationAktiv, nicht rekrutierend» Google-Maps
National University Cancer Institute (NCIS)
119074 Singapore
SingaporeRekrutierend» Google-Maps
Singapore General Hospital
169608 Singapore
SingaporeRekrutierend» Google-Maps
Institut Català d'Oncologia-Ho
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital Universitario de Gran
35019 Las Palmas de Gran Canaria
SpainRekrutierend» Google-Maps
Complejo Asistencial Universit
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario Doctor
46017 Valencia
SpainRekrutierend» Google-Maps
Chang Gung Medical Foundation
613 Chiayi City
TaiwanRekrutierend» Google-Maps
China Medical University Hospital - Hematology/Onc
404 Taichung City
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hospital
11217 Taipei
TaiwanNoch nicht rekrutierend» Google-Maps
Sakarya Research and Training Hospital - Medical Oncology
54100 Adapazarı
TurkeyRekrutierend» Google-Maps
Gazi University Medical Faculty
06560 Ankara
TurkeyRekrutierend» Google-Maps
Istanbul Üniversitesi Cerrahpaşa
34098 Istanbul
TurkeyRekrutierend» Google-Maps
Medipol Bagcilar Mega Hospital
34214 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Marmara university pendik training and research hospital
34899 Istanbul
TurkeyRekrutierend» Google-Maps
Mersin University Medical Faculty
33110 Yenisehir/Mersin
TurkeyRekrutierend» Google-Maps
Maidstone Hospital
ME16 9QQ Maidstone
United KingdomRekrutierend» Google-Maps
St Bartholomew's Hospital
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
Guys and St Thomas' Hospital
SE1 9RT London
United KingdomRekrutierend» Google-Maps
Oxford University Hospitals
OX3 9DS Oxford
United KingdomRekrutierend» Google-Maps
Alle anzeigen

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

- 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

Studien-Rationale

Primary outcome:

1. Overall survival (OS) (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 21 days)):
Maximum Observed Plasma Concentration (Cmax).

8. Assessment of Tmax (Time Frame - Day 1 of all cycles (each cycle is 21 days)):
Time to reach the maximum observed plasma concentration

9. Assessment of t1/2 (Time Frame - Day 1 of all cycles (each cycle is 21 days)):
Elimination half-life.

10. Assessment of AUC (Time Frame - Day 1 of all cycles (each cycle is 21 days)):
Area under the drug concentration-plasma time curve (AUC) from time zero to last measurable concentration

11. 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.

12. 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).

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. Participants on BAT who meet protocol-defined criteria for progressive disease may crossover to receive imetelstat treatment after sponsor's approval.

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, chemotherapy or radiotherapy.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"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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