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JOURNAL ONKOLOGIE – STUDIE
TRANSFORM-1

Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis

Rekrutierend

NCT-Nummer:
NCT04472598

Studienbeginn:
September 2020

Letztes Update:
03.06.2021

Wirkstoff:
Navitoclax, Ruxolitinib, Placebo for Navitoclax

Indikation (Clinical Trials):
Primary Myelofibrosis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 173)

Universitatsklinikum Mannheim /ID# 221523
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Haemato-Onkologie /ID# 221061
81241 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Aachen /ID# 221519
52074 Aachen
GermanyRekrutierend» Google-Maps
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen /ID# 221522
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
OncoResearch Lerchenfeld GmbH /ID# 230867
22081 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Rechts der Isar /ID# 221520
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Highlands Oncology Group /ID# 221824
72762 Springdale
United StatesRekrutierend» Google-Maps
Moore UC San Diego Cancer Center /ID# 218012
92093 La Jolla
United StatesNoch nicht rekrutierend» Google-Maps
Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562
80120 Littleton
United StatesRekrutierend» Google-Maps
Lynn Cancer Institute, Boca /ID# 230687
33486 Boca Raton
United StatesNoch nicht rekrutierend» Google-Maps
Florida Cancer Specialist - South /ID# 221726
33901-8108 Fort Myers
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - North /ID# 221727
33705-1449 Saint Petersburg
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists - East /ID# 221728
33401 West Palm Beach
United StatesRekrutierend» Google-Maps
Emory University /ID# 221562
30322-1013 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Augusta University Georgia Cancer Center /ID# 221551
30912-0003 Augusta
United StatesRekrutierend» Google-Maps
Columbus Regional Research Institute /ID# 227272
31904-8915 Columbus
United StatesRekrutierend» Google-Maps
Rush University Medical Center /ID# 221581
60612 Chicago
United StatesRekrutierend» Google-Maps
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
61761 Normal
United StatesRekrutierend» Google-Maps
Indiana Blood & Marrow Transpl /ID# 221586
46237 Indianapolis
United StatesNoch nicht rekrutierend» Google-Maps
University of Kansas Cancer Center /ID# 218144
66205-2528 Fairway
United StatesRekrutierend» Google-Maps
Massachusetts General Hospital /ID# 221559
02114 Boston
United StatesRekrutierend» Google-Maps
Beth Israel Deaconess Medical Center /ID# 224261
02215-5400 Boston
United StatesRekrutierend» Google-Maps
Dana-Farber Cancer Institute /ID# 218010
02215 Boston
United StatesRekrutierend» Google-Maps
University of Michigan Health Systems /ID# 221658
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Minnesota Oncology Hematology /ID# 227357
55435 Edina
United StatesRekrutierend» Google-Maps
MidAmerica Division, Inc. /ID# 221743
64132 Kansas City
United StatesRekrutierend» Google-Maps
Hackensack Univ Med Ctr /ID# 221654
07601 Hackensack
United StatesRekrutierend» Google-Maps
Northwell Health - Monter Cancer Center /ID# 222996
11042 Lake Success
United StatesNoch nicht rekrutierend» Google-Maps
Weill Cornell Medical College /ID# 220933
10021 New York
United StatesNoch nicht rekrutierend» Google-Maps
Univ Rochester Med Ctr /ID# 221657
14642 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Gabrail Cancer Center Research /ID# 230488
44718 Canton
United StatesNoch nicht rekrutierend» Google-Maps
Oncology Hematology Care, Inc - Kenwood /ID# 222556
45236-2725 Cincinnati
United StatesRekrutierend» Google-Maps
The Ohio State University /ID# 221584
43210 Columbus
United StatesRekrutierend» Google-Maps
West Penn Hospital /ID# 230165
15224-1722 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
UPMC Hillman Cancer Ctr /ID# 218134
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Medical University of South Carolina /ID# 230173
29425 Charleston
United StatesNoch nicht rekrutierend» Google-Maps
University of Texas MD Anderson Cancer Center /ID# 217994
77030 Houston
United StatesRekrutierend» Google-Maps
University of Utah /ID# 221009
84112-5500 Salt Lake City
United StatesRekrutierend» Google-Maps
St. Vincent's Hospital, Darlinghurst /ID# 221503
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Border Medical Oncology /ID# 231311
2640 East Albury
AustraliaNoch nicht rekrutierend» Google-Maps
Gosford Hospital /ID# 221499
2250 Gosford
AustraliaRekrutierend» Google-Maps
Liverpool Hospital /ID# 221803
2170 Liverpool
AustraliaRekrutierend» Google-Maps
Townsville University Hospital /ID# 229794
4814 Douglas
AustraliaNoch nicht rekrutierend» Google-Maps
Barwon Health /ID# 221804
3220 Geelong
AustraliaNoch nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Ctr /ID# 229795
3000 Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps
Alfred Health /ID# 221501
3004 Melbourne
AustraliaRekrutierend» Google-Maps
Royal Perth Hospital /ID# 223203
6000 Perth
AustraliaRekrutierend» Google-Maps
Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
4020 Linz
AustriaRekrutierend» Google-Maps
Klinikum Wels-Grieskirchen GmbH /ID# 220901
4600 Wels
AustriaRekrutierend» Google-Maps
Medizinische Universität Graz /ID# 220910
8020 Graz
AustriaRekrutierend» Google-Maps
Medical University of Vienna /ID# 220906
1090 Vienna
AustriaRekrutierend» Google-Maps
Universitair Ziekenhuis Leuven /ID# 218806
3000 Leuven
BelgiumRekrutierend» Google-Maps
AZ St-Jan Brugge-Oostende AV /ID# 218805
8000 Brugge
BelgiumRekrutierend» Google-Maps
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874
4000 Liege
BelgiumRekrutierend» Google-Maps
AZ Nikolaas /ID# 229861
9100 Sint-Niklaas
BelgiumNoch nicht rekrutierend» Google-Maps
UMHAT Dr Georgi Stranski EAD /ID# 231161
5800 Pleven
BulgariaNoch nicht rekrutierend» Google-Maps
UMHAT Sveti Georgi /ID# 231053
4002 Plovdiv
BulgariaNoch nicht rekrutierend» Google-Maps
Acibadem City Clinic UMHAT Tokuda /ID# 231036
1407 Sofia
BulgariaNoch nicht rekrutierend» Google-Maps
UMHAT Aleksandrovska /ID# 231056
1431 Sofia
BulgariaNoch nicht rekrutierend» Google-Maps
UMHAT Sveti Ivan Rilski /ID# 231028
1612 Sofia
BulgariaNoch nicht rekrutierend» Google-Maps
Royal Victoria Hospital /ID# 222636
L4M 6M2 Barrie
CanadaRekrutierend» Google-Maps
Juravinski Cancer Centre /ID# 221752
L8V 1C3 Hamilton
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Lakeridge Health - Oshawa /ID# 222080
L1G 2B9 Oshawa
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CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
G1J 1Z4 Quebec City
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Klinicka bolnica Dubrava Zagreb /ID# 230795
10000 Zagreb
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Klinicki bolnicki centar Zagreb /ID# 230793
10000 Zagreb
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Klinička bolnica Merkur /ID# 231155
10000 Zagreb
CroatiaNoch nicht rekrutierend» Google-Maps
Klinicki bolnicki centar Split /ID# 230796
21000 Split
CroatiaNoch nicht rekrutierend» Google-Maps
Hopital Haut-Lévêque /ID# 222518
33604 Pessac CEDEX
FranceRekrutierend» Google-Maps
CHRU Lille - Hopital Claude Huriez /ID# 219116
59045 Lille CEDEX
FranceNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Lyon Sud /ID# 222913
69495 Pierre Benite CEDEX
FranceRekrutierend» Google-Maps
Centre Hospitalier Metropole Savoie /ID# 224506
73000 Chambery
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CHU de Nantes, Hotel Dieu -HME /ID# 219113
44093 Nantes
FranceRekrutierend» Google-Maps
Hopital Saint Louis /ID# 221288
75475 Paris
FranceRekrutierend» Google-Maps
CHU de STRASBOURG - Hopital Ha /ID# 229978
67200 Strasbourg
FranceNoch nicht rekrutierend» Google-Maps
General Hospital of Athens Laiko /ID# 230785
11527 Athens
GreeceNoch nicht rekrutierend» Google-Maps
University General Hospital Attikon /ID# 230784
12462 Athens
GreeceNoch nicht rekrutierend» Google-Maps
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
10676 Athens
GreeceNoch nicht rekrutierend» Google-Maps
Hadassah Medical Center-Hebrew University /ID# 219110
91120 Jerusalem
IsraelRekrutierend» Google-Maps
Assaf Harofeh Medical Center /ID# 222957
70300 Be'er Ya'akov
IsraelRekrutierend» Google-Maps
Rambam Health Care Campus /ID# 219120
3109601 Haifa
IsraelRekrutierend» Google-Maps
Meir Medical Center /ID# 221374
4428164 Kfar Saba
IsraelRekrutierend» Google-Maps
Sheba Medical Center /ID# 219137
5239424 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center /ID# 219134
6423906 Tel Aviv-Yafo
IsraelRekrutierend» Google-Maps
A.O.U. Policlinico S.Orsola-Malpighi /ID# 220867
40138 Bologna
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS /ID# 219083
00168 Rome
ItalyRekrutierend» Google-Maps
ASST Papa Giovanni XXIII /ID# 221907
24127 Bergamo
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Policlinico G. Rodolico - San Marco /Id# 219085
95123 Catania
ItalyRekrutierend» Google-Maps
A.O. Circolo e Fondazione Macc /ID# 219084
21100 Varese
ItalyNoch nicht rekrutierend» Google-Maps
Fujita Health University Hospital /ID# 221537
470-1192 Toyoake-shi
JapanNoch nicht rekrutierend» Google-Maps
National Cancer Center Hospital East /ID# 226093
277-8577 Kashiwa-shi
JapanNoch nicht rekrutierend» Google-Maps
Ehime University Hospital /ID# 221443
791-0295 Toon-shi
JapanNoch nicht rekrutierend» Google-Maps
Kyushu University Hospital /ID# 221783
812-8582 Fukuoka-shi
JapanNoch nicht rekrutierend» Google-Maps
Fukushima Medical University Hospital /ID# 222752
960-1295 Fukushima-shi
JapanNoch nicht rekrutierend» Google-Maps
Gunma University Hospital /ID# 221480
371-8511 Maebashi-shi
JapanNoch nicht rekrutierend» Google-Maps
Mie University Hospital /ID# 221664
514-8507 Tsu-shi
JapanNoch nicht rekrutierend» Google-Maps
University of Miyazaki Hospital /ID# 221483
889-1692 Miyazaki-shi
JapanNoch nicht rekrutierend» Google-Maps
Kawasaki Medical School Hospital /ID# 221481
701-0192 Kurashiki-shi
JapanNoch nicht rekrutierend» Google-Maps
Kurashiki Central Hospital /ID# 221692
710-8602 Kurashiki-shi
JapanNoch nicht rekrutierend» Google-Maps
Kansai Medical University Hospital /ID# 221482
573-1191 Hirakata-shi
JapanNoch nicht rekrutierend» Google-Maps
Kindai University Hospital /ID# 221479
589-8511 Osaka-sayama-shi
JapanNoch nicht rekrutierend» Google-Maps
Osaka University Hospital /ID# 221478
565-0871 Suita-shi
JapanNoch nicht rekrutierend» Google-Maps
Dokkyo Medical University Saitama Medical Center /ID# 222333
343-8555 Koshigaya-shi
JapanNoch nicht rekrutierend» Google-Maps
Juntendo University Shizuoka Hospital /ID# 221782
410-2295 Izunokuni-shi
JapanNoch nicht rekrutierend» Google-Maps
Juntendo University Hospital /ID# 221405
113-8431 Bunkyo-ku
JapanNoch nicht rekrutierend» Google-Maps
Nippon Medical School Hospital /ID# 221674
113-8603 Bunkyo-ku
JapanNoch nicht rekrutierend» Google-Maps
University of Yamanashi Hospital /ID# 221701
409-3821 Chuo-shi
JapanNoch nicht rekrutierend» Google-Maps
Seoul National University Bundang Hospital /ID# 219053
13620 Seongnam
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Hospital /ID# 222087
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center /ID# 222089
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital /ID# 219055
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center /ID# 219054
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 221068
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Seoul ST. Mary's Hospital /ID# 219056
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Radboud Universitair Medisch Centrum /ID# 218948
6525 GA Nijmegen
NetherlandsRekrutierend» Google-Maps
Albert Schweitzer Ziekenhuis /ID# 224015
3318 AT Dordrecht
NetherlandsRekrutierend» Google-Maps
Universitair Medisch Centrum Groningen /ID# 218947
9713 GZ Groningen
NetherlandsRekrutierend» Google-Maps
Universitair Medisch Centrum Utrecht /ID# 218949
3584 CX Utrecht
NetherlandsRekrutierend» Google-Maps
Middlemore Clinical Trials /ID# 230770
2025 Auckland
New ZealandNoch nicht rekrutierend» Google-Maps
Russian Research Institute of Hematology and Transfusiology /ID# 221029
191024 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Clinic UZI 4D /ID# 221024
357502 Pyatigorsk
Russian FederationRekrutierend» Google-Maps
City Clinical Hospital named after S.P. Botkin /ID# 221025
125284 Moscow
Russian FederationRekrutierend» Google-Maps
Hospital n.a. V.V. Veresaev /ID# 226631
127644 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Republican hospital named after V.A. Baranov /ID# 221412
185019 Petrozavodsk
Russian FederationRekrutierend» Google-Maps
Leningrad Regional Clinical Hospital /ID# 221028
194291 Saint Petersburg
Russian FederationRekrutierend» Google-Maps
Federal Almazov N-W Med Res /ID# 221033
197341 St. Petersburg
Russian FederationRekrutierend» Google-Maps
Tula Regional Clinical Hospital /ID# 221027
300053 Tula
Russian FederationRekrutierend» Google-Maps
University Clinical Center Serbia /ID# 230854
11000 Belgrade
SerbiaNoch nicht rekrutierend» Google-Maps
Clin Hosp Ctr Bezanijska Kosa /ID# 230946
11080 Belgrade
SerbiaNoch nicht rekrutierend» Google-Maps
University Clinical Center Kragujevac /ID# 230855
34000 Kragujevac
SerbiaNoch nicht rekrutierend» Google-Maps
Clinical Center Vojvodina /ID# 230853
21000 Novi Sad
SerbiaNoch nicht rekrutierend» Google-Maps
Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Germans Trias i Pujol /ID# 229936
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Dr. Negrin /ID# 220897
35010 Las Palmas de Gran Canaria
SpainRekrutierend» Google-Maps
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720
31008 Pamplona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Parc de Salut del Mar /ID# 220913
08003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron /ID# 229690
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
28027 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal /ID# 220877
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre /ID# 229691
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Virgen de la Victoria /ID# 220878
29010 Malaga
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia /ID# 220875
46010 Valencia
SpainRekrutierend» Google-Maps
Skane University Hospital Lund /ID# 220835
SE 221 41 Lund
SwedenRekrutierend» Google-Maps
Sahlgrenska University Hosp /ID# 218776
413 45 Goteborg
SwedenRekrutierend» Google-Maps
Orebro Universitetssjukhuset /ID# 220829
701 85 Orebro
SwedenRekrutierend» Google-Maps
Karolinska University Hospital /ID# 219173
141 86 Stockholm
SwedenNoch nicht rekrutierend» Google-Maps
China Medical University Hosp /ID# 218978
40447 Taichung City
TaiwanRekrutierend» Google-Maps
National Taiwan Univ Hosp /ID# 218976
10002 Taipei City
TaiwanRekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital /ID# 218984
833 Kaohsiung
TaiwanRekrutierend» Google-Maps
Chi Mei Hospital - Liouying /ID# 221145
73657 Tainan City
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hosp /ID# 221146
11217 Taipei City
TaiwanRekrutierend» Google-Maps
Linkou Chang Gung Memorial Hos /ID# 218983
33350 Taoyuan County
TaiwanRekrutierend» Google-Maps
Hacettepe University Medical Faculty /ID# 230759
06250 Altindağ
TurkeyNoch nicht rekrutierend» Google-Maps
Trakya University Medical Facu /ID# 230754
22030 Edirne, Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
34214 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Ege University Medical Faculty /ID# 230753
35040 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Inonu University Medical Faculty /ID# 230758
44280 Malatya
TurkeyNoch nicht rekrutierend» Google-Maps
Communal non-profit enterprise Regional Center of Oncology /ID# 230832
61070 Kharkiv
UkraineNoch nicht rekrutierend» Google-Maps
Institute of Blood Pathology /ID# 230833
79044 Lviv
UkraineNoch nicht rekrutierend» Google-Maps
Guy's and St Thomas' NHS Found /ID# 219185
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
Heart of England NHS Foundation Trust /ID# 221333
B9 5SS Birmingham
United KingdomNoch nicht rekrutierend» Google-Maps
The Christie Hospital /ID# 219191
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Oxford Univ Hosp NHS Trust /ID# 219192
OX3 7LE Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
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Studien-Informationen

Brief Summary:

Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts

body's normal production of blood cells. It causes bone marrow scarring, leading to severe

anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting

cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an

enlarged spleen. The purpose of this study is to see if a combination of navitoclax and

ruxolitinib is more effective and safe in assessment of change in spleen volume when compared

to ruxolitinib in participants with myelofibrosis.

Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in

this study are divided into two groups, called treatment arms. Each group receives a

different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled.

Around 230 participants will be enrolled in approximately 130 sites worldwide.

Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral

ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue till

the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons

which qualify for discontinuation of the study drug.

There may be a higher treatment burden for participants in this trial compared to their

standard of care. Participants will attend regular visits during the course of the study at a

hospital or clinic. The effect of the treatment will be checked by medical assessments, blood

tests, Magnetic Resonance Imaging (MRI), bone marrow tests, checking for side effects, and

completing questionnaires.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Documented diagnosis of Primary MyeloFibrosis (MF) or Secondary MF (post polycythemia

vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) as defined by World

Health Organization (WHO) classification.

- Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out

of 7 days prior to randomization.

-- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as

measured by the MFSAF v4.0.

- Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International

Prognostic Scoring System Plus (DIPSS+).

- Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below

costal margin or spleen volume greater than or equal to 450 cubic cm as assessed

centrally by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.

- Ineligible for stem cell transplantation at time of study entry due to age,

comorbidities, or unfit for unrelated or unmatched donor transplant.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria:

- Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.

- Prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif

(BET) inhibitor.

- Receiving medication that interferes with coagulation or platelet function except for

low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH)

within 3 days prior to the first dose of study drug or during the study treatment

period.

Studien-Rationale

Primary outcome:

1. Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) (Time Frame - At Week 24):
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.



Secondary outcome:

1. Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS) (Time Frame - Baseline (Week 0) Up to Week 24):
Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.

2. Percentage of Participants who achieve Spleen Volume Reduction of at least 35% (SVR35) (Time Frame - Baseline (Week 0) Up to Week 96):
Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.

3. Duration of 35% Spleen Volume Reduction (SVR35) (Time Frame - Baseline (Week 0) Up to Week 96):
Duration of SVR35 is defined as the time between the date of first response of spleen volume reduction of 35% achievement to the date of disease progression, or to the date of death, whichever occurs first.

4. Change In Fatigue (Time Frame - Baseline (Week 0) Up to Week 24):
Change in fatigue will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue SF 7a.

5. Time to Deterioration of Physical Functioning (Time Frame - Baseline (Week 0) Up to Week 96):
Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 or death.

6. Proportion of Participants who achieve Anemia Response (Time Frame - Baseline (Week 0) Up to Week 96):
The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria.

7. Overall Survival (OS) (Time Frame - Up To approximately 5 Years):
OS is defined as the time from start of study to the date of death from any cause.

8. Leukemia-Free Survival (Time Frame - Up To approximately 5 Years):
Leukemia-free survival is defined as the number of days from the date of randomization to the onset date of documented leukemia, disease progression due to leukemia, or death due to leukemia, whichever occurs first.

9. Overall Response of Clinical Improvement (Time Frame - Baseline (Week 0) Up to Week 96):
Clinical improvement is defined as the achievement of anemia, spleen, or symptoms response without progressive disease, per International Working Group (IWG) criteria.

10. Percentage of Participants who achieve reduction in Grade of Bone Marrow Fibrosis (Time Frame - Baseline (Week 0) Up to Week 96):
Change in grade of bone marrow fibrosis will be measured per the European consensus grading system through bone marrow biopsy.

Studien-Arme

  • Experimental: Navitoclax + Ruxolitinib
    Participants will receive Navitoclax in combination with Ruxolitinib
  • Active Comparator: Placebo for Navitoclax + Ruxolitinib
    Participants will receive placebo for Navitoclax and Ruxolitinib

Geprüfte Regime

  • Navitoclax (ABT-263):
    Tablet; Oral
  • Ruxolitinib:
    Tablet; Oral
  • Placebo for Navitoclax:
    Tablet; Oral

Quelle: ClinicalTrials.gov


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