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JOURNAL ONKOLOGIE – STUDIE

TRANSFORM-2 Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

Rekrutierend

NCT-Nummer:
NCT04468984

Studienbeginn:
August 2020

Letztes Update:
04.02.2021

Wirkstoff:
Navitoclax, Ruxolitinib, Best Available Therapy (BAT)

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 178)

Universitatsklinikum Mannheim /ID# 221529
68167 Mannheim
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
BAG Freiberg-Richter /ID# 221346
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025
86150 Augsburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Bochum-Mitte Bochum, Germany /ID# 224695
44791 Bochum
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Chemnitz gGmbH /ID# 224575
09116 Chemnitz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
OncoResearch Lerchenfeld GmbH /ID# 225034
22081 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikum Rechts der Isar /ID# 221526
81675 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Stauferklinikum Schwaebisch Gmuend /ID# 223948
73557 Mutlangen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Rostock /ID# 224157
18055 Rostock
(Mecklenburg-Vorpommern)
GermanyNoch nicht rekrutierend» Google-Maps
Ironwood Cancer & Res Ctr /ID# 222162
85224-5665 Chandler
United StatesRekrutierend» Google-Maps
Highlands Oncology Group /ID# 221826
72762 Springdale
United StatesRekrutierend» Google-Maps
Moore UC San Diego Cancer Center /ID# 219009
92093 La Jolla
United StatesNoch nicht rekrutierend» Google-Maps
Long Beach Memorial Medical Ct /ID# 224542
90806 Long Beach
United StatesNoch nicht rekrutierend» Google-Maps
Icri /Id# 221967
90603 Whittier
United StatesNoch nicht rekrutierend» Google-Maps
St. Mary's Hospital Regional Cancer Center /ID# 224229
81501-6132 Grand Junction
United StatesRekrutierend» Google-Maps
Augusta University Georgia Cancer Center /ID# 219051
30912-0003 Augusta
United StatesNoch nicht rekrutierend» Google-Maps
Columbus Regional Research Institute /ID# 224410
31904-8915 Columbus
United StatesRekrutierend» Google-Maps
Loyola University Medical Ctr /ID# 219048
60153 Maywood
United StatesNoch nicht rekrutierend» Google-Maps
Indiana Blood & Marrow Transpl /ID# 221587
46237 Indianapolis
United StatesNoch nicht rekrutierend» Google-Maps
Tulane Medical Center - New Orleans /ID# 222940
70112-2600 New Orleans
United StatesRekrutierend» Google-Maps
Ochsner Clinic Foundation-New Orleans /ID# 222777
70121 New Orleans
United StatesNoch nicht rekrutierend» Google-Maps
Dana-Farber Cancer Institute /ID# 218998
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
University of Michigan /ID# 218463
48109-5000 Ann Arbor
United StatesRekrutierend» Google-Maps
William Beaumont Hospital /ID# 222705
48073-6710 Royal Oak
United StatesNoch nicht rekrutierend» Google-Maps
Saint Louis University Cancer Center /ID# 222287
63110-2539 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
Summit Medical Group - Florham Park /ID# 222620
07932-1049 Florham Park
United StatesRekrutierend» Google-Maps
Hackensack Univ Med Ctr /ID# 219047
07601 Hackensack
United StatesNoch nicht rekrutierend» Google-Maps
Manhattan Hematology Oncology MHO Associates /ID# 223193
10016-6028 New York
United StatesRekrutierend» Google-Maps
Weill Cornell Medical College /ID# 220866
10021 New York
United StatesNoch nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081
10065-6007 New York
United StatesNoch nicht rekrutierend» Google-Maps
Univ Rochester Med Ctr /ID# 219050
14642 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
Wake Forest Baptist Medical Center /ID# 222899
27157-0001 Winston-Salem
United StatesNoch nicht rekrutierend» Google-Maps
MetroHealth Medical Center /ID# 222650
44109 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Fox Chase Cancer Center /ID# 223955
19111 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Baylor Sammons Cancer Center /ID# 222632
75246 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Houston Methodist Hospital /ID# 223103
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
The Univ Texas HSC at Tyler /ID# 222810
75708 Tyler
United StatesNoch nicht rekrutierend» Google-Maps
Utah Cancer Specialists /ID# 221962
84106 Salt Lake City
United StatesNoch nicht rekrutierend» Google-Maps
Virginia Cancer Specialists /ID# 223016
22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Providence Everett /ID# 223130
98201 Everett
United StatesNoch nicht rekrutierend» Google-Maps
Yakima Valley Memorial Hosp /ID# 224368
98902 Yakima
United StatesRekrutierend» Google-Maps
HSHS St. Vincent Hospital /ID# 224468
54301 Green Bay
United StatesNoch nicht rekrutierend» Google-Maps
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 223848
2640 Albury
AustraliaRekrutierend» Google-Maps
The Kinghorn Cancer Centre /ID# 221097
2010 Darlinghurst
AustraliaNoch nicht rekrutierend» Google-Maps
The Tweed Hospital /ID# 224212
2485 Tweed Heads
AustraliaNoch nicht rekrutierend» Google-Maps
Calvary Mater Newcastle /ID# 224324
2298 Waratah
AustraliaRekrutierend» Google-Maps
The Alfred Hospital /ID# 221096
3181 Prahran
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Perth Hospital /ID# 221099
6008 Shenton Park
AustraliaRekrutierend» Google-Maps
LKH-Univ. Klinikum Graz /ID# 220919
8036 Graz
AustriaRekrutierend» Google-Maps
Universitaetsklinikum St. Poelten /ID# 221709
3100 St. Polten
AustriaNoch nicht rekrutierend» Google-Maps
Medizinische Universitaet Wien /ID# 220911
1090 Vienna
AustriaNoch nicht rekrutierend» Google-Maps
Klinikum Wels-Grieskirchen GmbH /ID# 220915
4600 Wels
AustriaRekrutierend» Google-Maps
Cliniques Universitaires Saint Luc /ID# 224221
1200 Woluwe-Saint-Lambert
BelgiumNoch nicht rekrutierend» Google-Maps
ZNA Stuivenberg /ID# 221468
2060 Antwerp
BelgiumNoch nicht rekrutierend» Google-Maps
Grand Hopital de Charleroi /ID# 224827
6000 Charleroi
BelgiumNoch nicht rekrutierend» Google-Maps
Ghent University hospital /ID# 220841
9000 Ghent
BelgiumNoch nicht rekrutierend» Google-Maps
AZ-Delta /ID# 221469
8800 Roeselare
BelgiumNoch nicht rekrutierend» Google-Maps
Juravinski Hosp & Cancer Cntr /ID# 220887
L8V 1C3 Hamilton
CanadaNoch nicht rekrutierend» Google-Maps
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433
G6V 3Z1 Levis
CanadaRekrutierend» Google-Maps
McGill University Health Center Research Institute /ID# 222614
H4A 3J1 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Fakultni Nemocnice Brno /ID# 220959
625 00 Brno
CzechiaNoch nicht rekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze /ID# 220969
128 00 Prague 28
CzechiaNoch nicht rekrutierend» Google-Maps
Aalborg University Hospital /ID# 224391
9000 Aalborg
DenmarkRekrutierend» Google-Maps
Sjællands Universitetshospital, Roskilde /ID# 224456
4000 Roskilde
DenmarkNoch nicht rekrutierend» Google-Maps
Hopital Haut-Lévêque /ID# 222696
33604 Pessac CEDEX
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud /ID# 222695
69495 Pierre Benite CEDEX
FranceRekrutierend» Google-Maps
Centre Hospitalier Metropole Savoie /ID# 223771
73000 Chambery
FranceRekrutierend» Google-Maps
CHU de Nantes, Hotel Dieu -HME /ID# 219127
44093 Nantes
FranceRekrutierend» Google-Maps
Hopital Saint Louis /ID# 221390
75475 Paris
FranceRekrutierend» Google-Maps
General Hospital of Athens Laiko /ID# 221175
115 27 Athens
GreeceNoch nicht rekrutierend» Google-Maps
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179
10676 Athens
GreeceRekrutierend» Google-Maps
Patras University General Hosp /ID# 221178
26504 Rion, Patras, Achaia
GreeceNoch nicht rekrutierend» Google-Maps
General Hospital of Thessaloniki George Papanikolaou /ID# 221463
57010 Thessaloniki
GreeceRekrutierend» Google-Maps
Debreceni Egyetem Klinikai Kozpont /ID# 220947
4032 Debrecen
HungaryRekrutierend» Google-Maps
Somogy Megyei Kaposi Mor Oktat /ID# 220948
7400 Kaposvar
HungaryRekrutierend» Google-Maps
Josa Andras Oktato Korhaz /ID# 220946
4400 Nyíregyháza
HungaryRekrutierend» Google-Maps
University of Szeged /ID# 220955
6720 Szeged
HungaryRekrutierend» Google-Maps
Fejer Megyei Szent Gyorgy Korhaz /ID# 220949
8000 Szekesfehervar
HungaryRekrutierend» Google-Maps
Rabin Medical Center /ID# 219139
4941492 Petakh Tikva
IsraelRekrutierend» Google-Maps
Hadassah Medical Center-Hebrew University /ID# 219111
91120 Jerusalem
IsraelRekrutierend» Google-Maps
HaEmek Medical Center /ID# 220839
1834111 Afula
IsraelRekrutierend» Google-Maps
Assuta Ashdod Medical Center /ID# 225281
7747629 Ashdod
IsraelNoch nicht rekrutierend» Google-Maps
Assaf Harofeh Medical Center /ID# 222972
70300 Be'er Ya'akov
IsraelRekrutierend» Google-Maps
Rambam Health Care Campus /ID# 219121
3109601 Haifa
IsraelRekrutierend» Google-Maps
Carmel Medical Center /ID# 222973
34362 Haifa
IsraelRekrutierend» Google-Maps
Galilee Medical Center /ID# 225280
22100 Nahariya
IsraelNoch nicht rekrutierend» Google-Maps
Sheba Medical Center /ID# 219136
5239424 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center /ID# 219135
6423906 Tel Aviv-Yafo
IsraelRekrutierend» Google-Maps
AOU Federico II /ID# 224673
80131 Naples
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Policlinico S.Orsola-Malpighi /ID# 221077
40138 Bologna
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Careggi /ID# 219090
50134 Florence
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Policlinico Umberto I /ID# 225731
00161 Rome
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS /ID# 219087
00168 Rome
ItalyNoch nicht rekrutierend» Google-Maps
AOU Citta della Salute Scienza /ID# 221223
10126 Turin
ItalyNoch nicht rekrutierend» Google-Maps
ASST Papa Giovanni XXIII /ID# 221222
24127 Bergamo
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Policlinico G. Rodolico - San Marco /Id# 219089
95123 Catania
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 225113
20052 Monza
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Policlinico Palermo /ID# 221078
90127 Palermo
ItalyNoch nicht rekrutierend» Google-Maps
Azieda Ospedaliera Bianchi Melacrino Morelli /ID# 221220
89125 Reggio Calabria
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Sanitaria Universitaria Friuli Centrale /ID# 221241
33100 Udine
ItalyNoch nicht rekrutierend» Google-Maps
ULSS na6 Vicenza /ID# 221079
36100 Vicenza
ItalyNoch nicht rekrutierend» Google-Maps
Japanese Red Cross Nagoya Daiichi Hospital /ID# 221150
453-8511 Nagoya-shi
JapanNoch nicht rekrutierend» Google-Maps
Fujita Health University Hospital /ID# 221598
470-1192 Toyoake-shi
JapanNoch nicht rekrutierend» Google-Maps
Chiba University Hospital /ID# 224546
260-8677 Chiba-shi
JapanNoch nicht rekrutierend» Google-Maps
National Cancer Center Hospital East /ID# 226653
277-8577 Kashiwa-shi
JapanNoch nicht rekrutierend» Google-Maps
Ehime University Hospital /ID# 221158
791-0295 Toon-shi
JapanNoch nicht rekrutierend» Google-Maps
Kyushu University Hospital /ID# 221606
812-8582 Fukuoka-shi
JapanNoch nicht rekrutierend» Google-Maps
Fukushima Medical University Hospital /ID# 221877
960-1295 Fukushima-shi
JapanNoch nicht rekrutierend» Google-Maps
Gifu University Hospital /ID# 224371
501-1194 Gifu-shi
JapanNoch nicht rekrutierend» Google-Maps
Sapporo Hokuyu Hospital /ID# 221149
003-0006 Sapporo-shi
JapanNoch nicht rekrutierend» Google-Maps
Kobe City Medical Center General Hospital /ID# 221156
650-0047 Kobe-shi
JapanNoch nicht rekrutierend» Google-Maps
Kanazawa University Hospital /ID# 223028
920-8641 Kanazawa-shi
JapanNoch nicht rekrutierend» Google-Maps
Iwate Medical University Hospital /ID# 222044
028-3695 Shiwa-gun
JapanNoch nicht rekrutierend» Google-Maps
Shonan Kamakura General Hospital /ID# 223030
247-8533 Kamakura-shi
JapanNoch nicht rekrutierend» Google-Maps
Kyoto University Hospital /ID# 223008
606-8507 Kyoto-shi
JapanNoch nicht rekrutierend» Google-Maps
Mie University Hospital /ID# 221665
514-8507 Tsu-shi
JapanNoch nicht rekrutierend» Google-Maps
University of Miyazaki Hospital /ID# 221821
889-1692 Miyazaki-shi
JapanNoch nicht rekrutierend» Google-Maps
Niigata University Medical & Dental Hospital /ID# 223034
951-8520 Niigata-shi
JapanNoch nicht rekrutierend» Google-Maps
Kurashiki Central Hospital /ID# 221690
710-8602 Kurashiki-shi
JapanNoch nicht rekrutierend» Google-Maps
Osaka University Hospital /ID# 221159
565-0871 Suita-shi
JapanNoch nicht rekrutierend» Google-Maps
Dokkyo Medical University Saitama Medical Center /ID# 222334
343-8555 Koshigaya-shi
JapanNoch nicht rekrutierend» Google-Maps
Juntendo University Shizuoka Hospital /ID# 221780
410-2295 Izunokuni-shi
JapanNoch nicht rekrutierend» Google-Maps
Juntendo University Hospital /ID# 221154
113-8431 Bunkyo-ku
JapanNoch nicht rekrutierend» Google-Maps
Nippon Medical School Hospital /ID# 221676
113-8603 Bunkyo-ku
JapanNoch nicht rekrutierend» Google-Maps
Tokyo Medical University Hospital /ID# 221540
160-0023 Shinjuku-ku
JapanNoch nicht rekrutierend» Google-Maps
University of Yamanashi Hospital /ID# 221706
409-3821 Chuo-shi
JapanNoch nicht rekrutierend» Google-Maps
Pusan National University Hosp /ID# 220980
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Gachon University Gil Medical Center /ID# 220972
21565 Incheon
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 221091
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic Univ. of Korea /ID# 219061
06591 Seocho-gu, Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital /ID# 219060
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopern /Id# 221161
93-513 Lodz
PolandRekrutierend» Google-Maps
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 221124
20-081 Lublin
PolandRekrutierend» Google-Maps
SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160
31-501 Krakow
PolandRekrutierend» Google-Maps
MTZ Clinical Research SP. zoo /ID# 221759
02-106 Warsaw
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne /ID# 221298
80-214 Gdansk
PolandNoch nicht rekrutierend» Google-Maps
Pratia Onkologia Katowice /ID# 224526
40-519 Katowice
PolandNoch nicht rekrutierend» Google-Maps
Lux Med Onkologia - Szpital Szamocka /Id# 221265
01-748 Warsaw
PolandRekrutierend» Google-Maps
Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281
00927 San Juan
Puerto RicoNoch nicht rekrutierend» Google-Maps
City Clinical Hospital named after S.P. Botkin /ID# 221116
125284 Moscow
Russian FederationRekrutierend» Google-Maps
City Clinical Hospital n.a. V.V. Veresaev of the Moscow Department of Healthcare /ID# 225221
127644 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Russian Scientific and Research Institute of Hematology and Transfusiology /ID# 221115
191024 Sankt-Peterburg
Russian FederationRekrutierend» Google-Maps
Federal North-West Medical Res /ID# 221114
197341 St. Petersburg
Russian FederationRekrutierend» Google-Maps
Tula Regional Clinical Hospital /ID# 221302
300053 Tula
Russian FederationRekrutierend» Google-Maps
Hospital Universitario A Coruña - CHUAC /ID# 224617
15006 A Coruña
SpainRekrutierend» Google-Maps
Hospital Clínico Universitario de Santiago-CHUS /ID# 221616
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
Hospital Universitario Central de Asturias /ID# 224815
33011 Oviedo
SpainNoch nicht rekrutierend» Google-Maps
Hospital Regional de Malaga /ID# 221906
29010 Málaga
SpainRekrutierend» Google-Maps
Hospital Parc de Salut del Mar /ID# 220922
08003 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Dr. Negrin /ID# 220923
35010 Las Palmas de Gran Canaria
SpainRekrutierend» Google-Maps
Hospital Universitario La Paz /ID# 224813
28046 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Salamanca /ID# 221904
37007 Salamanca
SpainRekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio /ID# 221932
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia /ID# 220920
46010 Valencia
SpainRekrutierend» Google-Maps
Skane University Hospital Lund /ID# 220834
SE 221 41 Lund
SwedenNoch nicht rekrutierend» Google-Maps
Universitaetsspital Basel /ID# 221261
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Inselspital Universitaetsklinik Bern /ID# 223439
3010 Bern
SwitzerlandRekrutierend» Google-Maps
China Medical University Hosp /ID# 218979
40447 Taichung City
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980
80708 Kaohsiung
TaiwanRekrutierend» Google-Maps
Kaohsiung Chang Gung Memorial Hospital /ID# 218985
833 Kaohsiung
TaiwanRekrutierend» Google-Maps
Chi Mei Hospital - Liouying /ID# 221144
73657 Tainan City
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hosp /ID# 221147
11217 Taipei City
TaiwanRekrutierend» Google-Maps
Linkou Chang Gung Memorial Hos /ID# 218982
33350 Taoyuan County
TaiwanRekrutierend» Google-Maps
Gulhane Askeri Tip Academy /ID# 224568
06010 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Trakya University Medical Facu /ID# 224572
22030 Edirne, Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Ege University Medical Faculty /ID# 224570
35040 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Mersin Univ Tip Fakult Hastane /ID# 224571
33000 Mersin
TurkeyNoch nicht rekrutierend» Google-Maps
Ondokuz mayis University Facul /ID# 224567
55139 Samsun
TurkeyNoch nicht rekrutierend» Google-Maps
Guy's and St Thomas' NHS Found /ID# 221041
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
Heart of England NHS Foundation Trust /ID# 221334
B9 5SS Birmingham
United KingdomNoch nicht rekrutierend» Google-Maps
Western General Hospital /ID# 224378
EH4 2XU Edinburgh
United KingdomNoch nicht rekrutierend» Google-Maps
James Paget University Hosp /ID# 221219
NR31 6LA Great Yarmouth
United KingdomRekrutierend» Google-Maps
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 221335
NE7 7DN Newcastle Upon Tyne
United KingdomRekrutierend» Google-Maps
Oxford Univ Hosp NHS Trust /ID# 221044
OX3 7LE Oxford
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

Myelofibrosis (MF) is a bone marrow illness that affects blood-forming tissues in the body.

MF disturbs the body's normal production of blood cells, causing extensive scarring in the

bone marrow. This leads to severe anemia, weakness, fatigue, and an enlarged spleen. The

purpose of this study is to assess safety and change in spleen volume when navitoclax is

given in combination with ruxolitinib, as compared to best available therapy, for adult

participants with MF.

Navitoclax is an investigational drug (not yet approved) being developed for the treatment of

MF. The study has 2 arms - A and B. In Arm A, participants will receive navitoclax in

combination with ruxolitinib. In Arm B, participants will receive the best available therapy

(BAT) for MF. Adult participants with a diagnosis of relapsed/refractory (R/R) MF will be

enrolled. Approximately 330 participants will be enrolled in approximately 190 sites across

the world.

In Arm A, participants will receive oral navitoclax tablet once daily with oral ruxolitinib

tablet twice daily. In Arm B, participants will receive the BAT as identified by the

investigator. Treatment will continue until clinical benefit is not seen, participants cannot

tolerate the study drugs, or participants withdraw consent. The approximate treatment

duration is about 3 years.

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

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

clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow

tests, checking for side effects, and completing questionnaires.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Must be able to complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at

least 4 out of 7 days prior to randomization.

-- Has at least 2 symptoms with a score >= 3 or a total score of >= 12, as measured by

the MFSAF v4.0.

- Documented diagnosis of primary myelofibrosis (MF), post polycythemia vera (PPV)-MF,

or post essential thrombocytopenia (PET)-MF as defined by the World Health

Organization (WHO) classification.

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

Prognostic Scoring System Plus (DIPSS+).

- Must currently be on treatment or have received prior treatment with a single Janus

Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in

addition to the minimum splenomegaly and symptom burden also required for

eligibility):

- Treatment with ruxolitinib for >= 24 weeks that was stopped due to loss of spleen

response (refractory), or loss of spleen response or symptom control after a

previous response (relapsed), or was continued despite relapsed/refractory

status.

- Treatment with ruxolitinib for < 24 weeks with documented disease progression

while on therapy as defined by any of the following:

- Appearance of new splenomegaly that is palpable to at least 5 cm below the

left costal margin (LCM) in participants with no evidence of splenomegaly

prior to the initiation of ruxolitinib.

- A >= 100% increase in the palpable distance below the LCM in participants

with measurable spleen distance 5 to 10 centimeters (cm) prior to the

initiation of ruxolitinib.

- A >= 50% increase in the palpable distance below the LCM in participants

with measurable spleen distance > 10 cm prior to the initiation of

ruxolitinib.

- A spleen volume increase of >= 25% (as assessed by Magnetic Resonance

Imaging [MRI] or Computed Tomography [CT] scan) in participants with a

spleen volume assessment prior to the initiation of ruxolitinib.

- Prior or current treatment with ruxolitinib for >= 28 days with intolerance defined as

new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving

a total daily ruxolitinib dose of >= 30 mg but unable to reduce dose further due to

lack of efficacy.

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

- Splenomegaly defined as palpable spleen measurement >= 5 cm below costal margin or

spleen volume >= 450 cm3 as assessed centrally by MRI or CT scan.

- Baseline platelet count >= 100 × 10^9/L.

Exclusion Criteria:

- Received prior treatment with a BH3-mimetic compound, bromodomain and extra-terminal

(BET) inhibitor, or prior use of > 1 JAK2 inhibitor.

- Eligible for allogeneic stem cell transplantation at the time of study entry.

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

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

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

period.

- Receiving anticancer therapy including chemotherapy, radiation therapy, hormonal

therapy (with the exception of hormones for thyroid conditions or estrogen replacement

therapy) within 30 days prior to first dose of study drug, and during the study

treatment period (other than any overlapping therapy as part of the selected BAT).

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 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 Short Form (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 achieved 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 (Time Frame - Up to approximately 3 years):
Overall survival 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 3 years):
Leukemia free survival is the time from start of study to the date of development of leukemia.

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: Arm A: Navitoclax + Ruxolitinib
    Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
  • Active Comparator: Arm B: Best Available Therapy (BAT)
    Participants will receive one of the BAT options, per the investigator's discretion.

Geprüfte Regime

  • Navitoclax (ABT-263):
    Tablet; Oral
  • Ruxolitinib:
    Tablet; Oral
  • Best Available Therapy (BAT):
    Tablet/Capsule; Oral or Solution for Subcutaneous Injection

Quelle: ClinicalTrials.gov


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