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

April 2, 2024 updated by: AbbVie

A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)

Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, 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. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. 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 MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 210 sites across the world.

In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. Participants will receive the study drug until they experience no benefit (determined by the investigator), 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.

Study Overview

Status

Recruiting

Conditions

Myelofibrosis (MF)

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

330

Phase

Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: ABBVIE CALL CENTER
Phone Number: 844-663-3742
Email: abbvieclinicaltrials@abbvie.com

Study Locations

Australia
- New South Wales
  - Darlinghurst, New South Wales, Australia, 2010
    - Recruiting
    - The Kinghorn Cancer Centre /ID# 221097
  - East Albury, New South Wales, Australia, 2640
    - Recruiting
    - Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 223848
  - Waratah, New South Wales, Australia, 2298
    - Recruiting
    - Calvary Mater Newcastle /ID# 224324
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - Recruiting
    - Alfred Health /ID# 221096
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Recruiting
    - Royal Perth Hospital /ID# 221099
Austria
- - Wien, Austria, 1140
    - Recruiting
    - Hanusch Krankenhaus /ID# 220912
- Niederoesterreich
  - Sankt Poelten, Niederoesterreich, Austria, 3100
    - Recruiting
    - Universitaetsklinikum St. Poelten /ID# 221709
- Oberoesterreich
  - Linz, Oberoesterreich, Austria, 4010
    - Recruiting
    - Ordensklinikum Linz GmbH Elisabethinen /ID# 220914
  - Wels, Oberoesterreich, Austria, 4600
    - Recruiting
    - Klinikum Wels-Grieskirchen GmbH /ID# 220915
- Steiermark
  - Graz, Steiermark, Austria, 8010
    - Recruiting
    - Medizinische Universitaet Graz /ID# 220919
- Wien
  - Vienna, Wien, Austria, 1090
    - Completed
    - Medizinische Universitaet Wien /ID# 220911
Belgium
- - Sint-Niklaas, Belgium, 9100
    - Recruiting
    - Vitaz /Id# 228150
- Antwerpen
  - Antwerp, Antwerpen, Belgium, 2030
    - Recruiting
    - ZNA Cadix /ID# 221468
- Bruxelles-Capitale
  - Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
    - Completed
    - UCL Saint-Luc /ID# 224221
- Hainaut
  - Charleroi, Hainaut, Belgium, 6000
    - Recruiting
    - Grand Hopital de Charleroi /ID# 224827
- Oost-Vlaanderen
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent /ID# 220841
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - Recruiting
    - AZ-Delta /ID# 221469
Bulgaria
- - Pleven, Bulgaria, 5800
    - Recruiting
    - UMHAT Dr Georgi Stranski EAD /ID# 231650
  - Sofia, Bulgaria, 1407
    - Recruiting
    - Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649
  - Sofia, Bulgaria, 1431
    - Recruiting
    - UMHAT Sveti Ivan Rilski /ID# 231651
  - Varna, Bulgaria, 9010
    - Recruiting
    - UMHAT Sveta Marina /ID# 234119
- Sofia
  - Sofiya, Sofia, Bulgaria, 1431
    - Recruiting
    - UMHAT Alexandrovska EAD /ID# 231652
Canada
- Ontario
  - Hamilton, Ontario, Canada, L8V 1C3
    - Recruiting
    - Juravinski Cancer Centre /ID# 220887
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - Ottawa Hospital Research Institute /ID# 238858
  - Toronto, Ontario, Canada, M5G 2M9
    - Recruiting
    - Princess Margaret Cancer Centre /ID# 253942
- Quebec
  - Levis, Quebec, Canada, G6V 3Z1
    - Recruiting
    - CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433
    - Contact:
      
      Site Coordinator
      
      Phone Number: 14188307474
  - Montreal, Quebec, Canada, H4A 3J1
    - Recruiting
    - McGill University Health Center Research Institute /ID# 222614
Croatia
- - Osijek, Croatia, 31000
    - Recruiting
    - Klinicki bolnicki centar Osijek /ID# 231503
- Grad Zagreb
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Dubrava /ID# 230801
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Recruiting
    - Klinicka bolnica Merkur /ID# 230799
  - Zagreb, Grad Zagreb, Croatia, 10000
    - Active, not recruiting
    - Klinicki bolnicki centar Zagreb /ID# 230798
- Splitsko-dalmatinska Zupanija
  - Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
    - Recruiting
    - Klinicki Bolnicki Centar (KBC) Split - Firule /ID# 230800
Czechia
- - Brno, Czechia, 613 00
    - Recruiting
    - Fakultni nemocnice Brno /ID# 220959
  - Praha, Czechia, 128 08
    - Completed
    - Vseobecna fakultni nemocnice v Praze /ID# 220969
Denmark
- Nordjylland
  - Aalborg, Nordjylland, Denmark, 9000
    - Recruiting
    - Aalborg University Hospital /ID# 224391
- Sjælland
  - Roskilde, Sjælland, Denmark, 4000
    - Recruiting
    - Roskilde Sygehus /ID# 224456
France
- - Angers, France, 49933
    - Completed
    - Chu Angers /Id# 219129
  - Paris, France, 75010
    - Recruiting
    - AP-HP - Hopital Saint-Louis /ID# 221390
- Alpes-Maritimes
  - Nice, Alpes-Maritimes, France, 06200
    - Recruiting
    - Chu de Nice-Hopital L'Archet Ii /Id# 256291
- Gard
  - Nimes CEDEX 9, Gard, France, 30029
    - Recruiting
    - CHU NIMES - Hopital Caremeau /ID# 219128
- Gironde
  - Pessac, Gironde, France, 33604
    - Recruiting
    - CHU Bordeaux - Hopital Haut Leveque /ID# 222696
- Ile-de-France
  - Bobigny, Ile-de-France, France, 93000
    - Completed
    - Hopital Avicenne - APHP /ID# 221287
- Pays-de-la-Loire
  - Nantes, Pays-de-la-Loire, France, 44000
    - Completed
    - CHU de Nantes, Hotel Dieu -HME /ID# 219127
- Rhone
  - Pierre Benite CEDEX, Rhone, France, 69495
    - Recruiting
    - HCL - Hopital Lyon Sud /ID# 222695
- Savoie
  - Chambery, Savoie, France, 73000
    - Recruiting
    - Centre Hospitalier de CHAMBERY /ID# 223771
Germany
- - Bochum, Germany, 44791
    - Completed
    - Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695
  - Chemnitz, Germany, 09116
    - Recruiting
    - Klinikum Chemnitz gGmbH /ID# 224575
  - Hamburg, Germany, 22081
    - Completed
    - OncoResearch Lerchenfeld GmbH /ID# 225034
  - Munich, Germany, 81675
    - Recruiting
    - Klinikum rechts der Isar /ID# 221526
  - Rostock, Germany, 18057
    - Recruiting
    - Universitaetsmedizin Rostock /ID# 224157
- Baden-Wuerttemberg
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - Recruiting
    - Universitatsklinikum Mannheim /ID# 221529
  - Mutlangen, Baden-Wuerttemberg, Germany, 73557
    - Recruiting
    - Stauferklinikum Schwaebisch Gmuend /ID# 223948
- Bayern
  - Augsburg, Bayern, Germany, 86150
    - Completed
    - Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - Recruiting
    - BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346
Greece
- - Athens, Greece, 10676
    - Recruiting
    - General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179
  - Patras, Greece, 26443
    - Recruiting
    - Olympion General Clinic SA /ID# 261423
  - RION Patras Achaia, Greece, 26504
    - Completed
    - University General Hospital of Patras /ID# 221178
  - Thessaloniki, Greece, 57010
    - Recruiting
    - General Hospital of Thessaloniki George Papanikolaou /ID# 221463
- Attiki
  - Athens, Attiki, Greece, 11527
    - Recruiting
    - General Hospital of Athens Laiko /ID# 221175
Hungary
- Csongrad
  - Szeged, Csongrad, Hungary, 6720
    - Recruiting
    - Szegedi Tudomanyegyetem /ID# 220955
- Fejer
  - Szekesfehervar, Fejer, Hungary, 8000
    - Recruiting
    - Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949
- Hajdu-Bihar
  - Debrecen, Hajdu-Bihar, Hungary, 4032
    - Recruiting
    - Debreceni Egyetem Klinikai Kozpont /ID# 220947
- Somogy
  - Kaposvár, Somogy, Hungary, 7400
    - Completed
    - Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948
- Szabolcs-Szatmar-Bereg
  - Nyiregyhaza, Szabolcs-Szatmar-Bereg, Hungary, 4400
    - Recruiting
    - Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946
Israel
- - Afula, Israel, 1834111
    - Recruiting
    - Clalit Health Services - Emek Medical Center /ID# 220839
- H_efa
  - Haifa, H_efa, Israel, 3109601
    - Completed
    - Rambam Health Care Campus /ID# 219121
  - Haifa, H_efa, Israel, 34362
    - Recruiting
    - The Lady Davis Carmel Medical Center /ID# 222973
  - Haifa, H_efa, Israel, 4941492
    - Recruiting
    - Rabin Medical Center /ID# 219139
- HaDarom
  - Ashdod, HaDarom, Israel, 7747629
    - Recruiting
    - Assuta Ashdod Medical Center /ID# 225281
- HaMerkaz
  - Zerifin, HaMerkaz, Israel, 70300
    - Recruiting
    - Assaf Harofeh Medical Center /ID# 222972
- HaTsafon
  - Nahariya, HaTsafon, Israel, 2210001
    - Recruiting
    - Galilee Medical Center /ID# 225280
- Tel-Aviv
  - Ramat Gan, Tel-Aviv, Israel, 5265601
    - Recruiting
    - The Chaim Sheba Medical Center /ID# 219136
  - Tel Aviv, Tel-Aviv, Israel, 6423906
    - Recruiting
    - Tel Aviv Sourasky Medical Center /ID# 219135
- Yerushalayim
  - Jerusalem, Yerushalayim, Israel, 91120
    - Recruiting
    - Hadassah Medical Center-Hebrew University /ID# 219111
  - Jerusalem, Yerushalayim, Israel, 9765400
    - Recruiting
    - Hadassah Mt. Scopus /ID# 253394
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221222
  - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 221077
  - Catania, Italy, 95123
    - Recruiting
    - A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219089
  - Florence, Italy, 50134
    - Recruiting
    - Azienda Ospedaliero Universitaria Careggi /ID# 219090
  - Napoli, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Universitaria Federico II /ID# 224673
  - Palermo, Italy, 90127
    - Recruiting
    - Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 221078
  - Reggio Calabria, Italy, 89124
    - Recruiting
    - Grande Ospedale Metropolitano Bianchi Melacrino Morelli /ID# 221220
  - Udine, Italy, 33100
    - Recruiting
    - Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 221241
  - Varese, Italy, 21100
    - Recruiting
    - ASST Sette Laghi /ID# 234183
  - Vicenza, Italy, 36100
    - Recruiting
    - Azienda ULSS 8 Berica/Ospedale San Bortolo di Vicenza /ID# 221079
- Ancona
  - Torette, Ancona, Italy, 60020
    - Recruiting
    - Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona /ID# 238438
- Lazio
  - Rome, Lazio, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219087
- Monza E Brianza
  - Monza, Monza E Brianza, Italy, 20900
    - Recruiting
    - ASST Monza/Ospedale San Gerardo /ID# 225113
- Piemonte
  - Torino, Piemonte, Italy, 10126
    - Recruiting
    - AOU Citta della Salute e della Scienza di Torino /ID# 221223
- Roma
  - Rome, Roma, Italy, 00161
    - Recruiting
    - Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 453-8511
    - Recruiting
    - Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150
  - Toyoake, Aichi, Japan, 470-1192
    - Recruiting
    - Fujita Health University /ID# 221598
- Aomori
  - Aomori-shi, Aomori, Japan, 030-8553
    - Recruiting
    - Aomori Prefectural Central Hospital /ID# 221778
- Chiba
  - Chiba-shi, Chiba, Japan, 260-8677
    - Recruiting
    - Chiba University Hospital /ID# 224546
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East /ID# 226653
- Ehime
  - Toon-shi, Ehime, Japan, 791-0295
    - Recruiting
    - Ehime University Hospital /ID# 221158
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital /ID# 221606
- Fukushima
  - Fukushima-shi, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital /ID# 221877
- Gifu
  - Gifu-shi, Gifu, Japan, 501-1194
    - Recruiting
    - Gifu University Hospital /ID# 224371
- Hokkaido
  - Sapporo-shi, Hokkaido, Japan, 003-0006
    - Recruiting
    - Sapporo Hokuyu Hospital /ID# 221149
- Hyogo
  - Kobe-shi, Hyogo, Japan, 650-0047
    - Recruiting
    - Kobe City Medical Center General Hospital /ID# 221156
- Ishikawa
  - Kanazawa-shi, Ishikawa, Japan, 920-8641
    - Recruiting
    - Kanazawa University Hospital /ID# 223028
- Iwate
  - Shiwa-gun, Iwate, Japan, 028-3695
    - Recruiting
    - Iwate Medical University Hospital /ID# 222044
- Kanagawa
  - Kamakura-shi, Kanagawa, Japan, 247-8533
    - Recruiting
    - Shonan Kamakura General Hospital /ID# 223030
- Kumamoto
  - Kumamoto-shi, Kumamoto, Japan, 862-8655
    - Recruiting
    - Kumamoto Shinto General Hospital /ID# 255645
- Kyoto
  - Kyoto-shi, Kyoto, Japan, 606-8507
    - Recruiting
    - Kyoto University Hospital /ID# 223008
- Mie
  - Tsu-shi, Mie, Japan, 514-8507
    - Recruiting
    - Mie University Hospital /ID# 221665
- Miyazaki
  - Miyazaki-shi, Miyazaki, Japan, 889-1692
    - Recruiting
    - University of Miyazaki Hospital /ID# 221821
- Niigata
  - Niigata-shi, Niigata, Japan, 951-8520
    - Recruiting
    - Niigata University Medical & Dental Hospital /ID# 223034
- Okayama
  - Kurashiki-shi, Okayama, Japan, 710-8602
    - Recruiting
    - Kurashiki Central Hospital /ID# 221690
- Osaka
  - Hirakata-shi, Osaka, Japan, 573-1191
    - Recruiting
    - Kansai Medical University Hospital /ID# 257289
    - Contact:
      
      Site Coordinator
      
      Phone Number: +81-72-804-2808
  - Suita-shi, Osaka, Japan, 565-0871
    - Recruiting
    - Osaka University Hospital /ID# 221159
- Saitama
  - Koshigaya-shi, Saitama, Japan, 343-8555
    - Recruiting
    - Dokkyo Medical University Saitama Medical Center /ID# 222334
- Shizuoka
  - Izunokuni-shi, Shizuoka, Japan, 410-2295
    - Recruiting
    - Juntendo University Shizuoka Hospital /ID# 221780
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8431
    - Recruiting
    - Juntendo University Hospital /ID# 221154
  - Bunkyo-ku, Tokyo, Japan, 113-8602
    - Recruiting
    - Nippon Medical School Hospital /ID# 221676
  - Minato-ku, Tokyo, Japan, 108-8639
    - Recruiting
    - The Institute of Medical Science the University of Tokyo Hospital /ID# 257944
  - Shinjuku-ku, Tokyo, Japan, 160-0023
    - Recruiting
    - Tokyo Medical University Hospital /ID# 221540
  - Sumida-ku, Tokyo, Japan, 130-8575
    - Recruiting
    - Tokyo Metropolitan Bokutoh Hospital /ID# 254774
- Yamanashi
  - Chuo-shi, Yamanashi, Japan, 409-3821
    - Recruiting
    - University of Yamanashi Hospital /ID# 221706
Korea, Republic of
- - Busan, Korea, Republic of, 49241
    - Recruiting
    - Pusan National University Hospital /ID# 220980
  - Incheon, Korea, Republic of, 21565
    - Recruiting
    - Gachon University Gil Medical Center /ID# 220972
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital /ID# 219060
  - Seoul, Korea, Republic of, 06351
    - Recruiting
    - Samsung Medical Center /ID# 221091
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06591
    - Recruiting
    - The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219061
New Zealand
- Auckland
  - Papatoetoe, Auckland, New Zealand, 2025
    - Recruiting
    - Aotearoa Clinical Trials /ID# 232201
Poland
- - Katowice, Poland, 40-519
    - Completed
    - Pratia Onkologia Katowice /ID# 224526
- Lodzkie
  - Lodz, Lodzkie, Poland, 93-513
    - Recruiting
    - Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im. M. Kopern /Id# 221161
- Lubelskie
  - Lublin, Lubelskie, Poland, 20-081
    - Recruiting
    - Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 221124
- Malopolskie
  - Krakow, Malopolskie, Poland, 31-501
    - Completed
    - SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160
- Mazowieckie
  - Warszawa, Mazowieckie, Poland, 01-748
    - Completed
    - Lux Med Onkologia - Szpital Szamocka /Id# 221265
  - Warszawa, Mazowieckie, Poland, 02-172
    - Recruiting
    - MTZ Clinical Research Powered by Pratia /ID# 221759
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-214
    - Recruiting
    - Uniwersyteckie Centrum Kliniczne /ID# 221298
- Wielkopolskie
  - Pila, Wielkopolskie, Poland, 64-920
    - Recruiting
    - ARS-MEDICAL Sp. z o.o. /ID# 238336
  - Poznan, Wielkopolskie, Poland, 60-569
    - Recruiting
    - Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Recruiting
    - Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281
Russian Federation
- - Moscow, Russian Federation, 127644
    - Completed
    - Hospital n.a. V.V. Veresaev /ID# 225221
  - Sankt-Peterburg, Russian Federation, 191024
    - Active, not recruiting
    - Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115
  - Sankt-Peterburg, Russian Federation, 197341
    - Active, not recruiting
    - Almazov National Medical Research Centre /ID# 221114
  - Tula, Russian Federation, 300053
    - Completed
    - Tula Regional Clinical Hospital /ID# 221302
- Moskva
  - Moscow, Moskva, Russian Federation, 125284
    - Active, not recruiting
    - Moscow State budget healthcare /ID# 221116
Serbia
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Recruiting
    - University Clinical Center Serbia /ID# 231058
  - Belgrade, Beograd, Serbia, 11080
    - Recruiting
    - Clin Hosp Ctr Bezanijska Kosa /ID# 231059
- Vojvodina
  - Novi Sad, Vojvodina, Serbia, 21000
    - Recruiting
    - Clinical Center Vojvodina /ID# 231057
South Africa
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2193
    - Completed
    - Wits Clinical Research Site /ID# 231554
  - Pretoria, Gauteng, South Africa, 0044
    - Recruiting
    - Alberts Cellular Therapy /ID# 231556
Spain
- - A Coruna, Spain, 15006
    - Recruiting
    - Hospital Universitario A Coruna - CHUAC /ID# 224617
  - Barcelona, Spain, 08003
    - Recruiting
    - Hospital Parc de Salut del Mar /ID# 220922
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitario Vall d'Hebron /ID# 240979
  - Granada, Spain, 18014
    - Recruiting
    - Hospital Universitario Virgen de las Nieves /ID# 253936
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre /ID# 233726
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz /ID# 224813
  - Malaga, Spain, 29011
    - Completed
    - Hospital Regional Universitario de Malaga /ID# 221906
  - Salamanca, Spain, 37711
    - Completed
    - Hospital Universitario de Salamanca /ID# 221904
  - Sevilla, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio /ID# 221932
  - Valencia, Spain, 46010
    - Recruiting
    - Hospital Clinico Universitario de Valencia /ID# 220920
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Recruiting
    - Hospital Clínico Universitario de Santiago-CHUS /ID# 221616
- Asturias
  - Oviedo, Asturias, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias /ID# 224815
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Recruiting
    - Hospital Universitario Germans Trias i Pujol /ID# 233727
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35019
    - Recruiting
    - Hospital Universitario Dr. Negrin /ID# 220923
Sweden
- Skane Lan
  - Lund, Skane Lan, Sweden, 224 84
    - Recruiting
    - Skane University Hospital Lund /ID# 220834
Switzerland
- - Bern, Switzerland, 3010
    - Completed
    - Inselspital, Universitaetsspital Bern /ID# 223439
- Basel-Stadt
  - Basel, Basel-Stadt, Switzerland, 4031
    - Completed
    - Universitätsspital Basel /ID# 221261
Taiwan
- - Kaohsiung, Taiwan, 807
    - Completed
    - Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980
  - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital /ID# 218979
  - Tainan City, Taiwan, 73657
    - Recruiting
    - Chi Mei Hospital - Liouying /ID# 221144
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hosp /ID# 221147
  - Taoyuan City, Taiwan, 333
    - Recruiting
    - Linkou Chang Gung Memorial Hospital /ID# 218982
- Kaohsiung
  - Kaohsiung City, Kaohsiung, Taiwan, 833
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital /ID# 218985
Turkey
- - Ankara, Turkey, 06010
    - Completed
    - Gulhane Askeri Tip Academy /ID# 224568
  - Edirne, Istanbul, Turkey, 22030
    - Recruiting
    - Trakya University Medical Facu /ID# 224572
  - Izmir, Turkey, 35040
    - Recruiting
    - Ege University Medical Faculty /ID# 224570
  - Mersin, Turkey, 33343
    - Recruiting
    - Mersin University Medical /ID# 224571
  - Samsun, Turkey, 55200
    - Recruiting
    - Ondokuz mayis University Facul /ID# 224567
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - Recruiting
    - University Hospitals Birmingham NHS Foundation Trust /ID# 221334
  - Edinburgh, United Kingdom, EH3 9HE
    - Recruiting
    - NHS Lothian /ID# 224378
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335
- Lincolnshire
  - Lincoln, Lincolnshire, United Kingdom, LN2 4AX
    - Recruiting
    - United Lincolnshire Hospitals NHS Trust /ID# 224613
- London, City Of
  - London, London, City Of, United Kingdom, SE1 9RT
    - Recruiting
    - Guys and St Thomas NHS Foundation Trust /ID# 221041
- Norfolk
  - Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
    - Recruiting
    - James Paget University Hospitals NHS Foundation Trust /ID# 221219
United States
- Arizona
  - Chandler, Arizona, United States, 85224-5665
    - Completed
    - Ironwood Cancer & Res Ctr /ID# 222162
- Arkansas
  - Springdale, Arkansas, United States, 72762
    - Recruiting
    - Highlands Oncology Group, PA /ID# 221826
- California
  - La Jolla, California, United States, 92093
    - Completed
    - Moores Cancer Center at UC San Diego /ID# 219009
  - Long Beach, California, United States, 90806-1701
    - Recruiting
    - Long Beach Memorial Medical Ct /ID# 224542
  - Whittier, California, United States, 90603
    - Recruiting
    - Icri /Id# 221967
- Colorado
  - Grand Junction, Colorado, United States, 81501-6132
    - Recruiting
    - St. Mary's Hospital Regional Cancer Center /ID# 224229
- Georgia
  - Augusta, Georgia, United States, 30912-0003
    - Recruiting
    - Augusta University Georgia Cancer Center /ID# 219051
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Columbus, Georgia, United States, 31904-8915
    - Completed
    - Columbus Regional Research Institute /ID# 224410
- Illinois
  - Elk Grove Village, Illinois, United States, 60007-3361
    - Recruiting
    - Northwest Oncology & Hematology - Elk Grove Village /ID# 222818
  - Maywood, Illinois, United States, 60153
    - Recruiting
    - Loyola University Medical Ctr /ID# 219048
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Recruiting
    - Indiana Blood & Marrow Transpl /ID# 221587
- Louisiana
  - New Orleans, Louisiana, United States, 70112-2600
    - Completed
    - Tulane Medical Center - New Orleans /ID# 222940
  - New Orleans, Louisiana, United States, 70121
    - Completed
    - Ochsner Clinic Foundation-New Orleans /ID# 222777
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - American Oncology Partners of Maryland, PA /ID# 222836
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana-Farber Cancer Institute /ID# 218998
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan /ID# 218463
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System /ID# 221190
  - Royal Oak, Michigan, United States, 48073-6710
    - Recruiting
    - William Beaumont Hospital /ID# 222705
- Missouri
  - Saint Louis, Missouri, United States, 63110-2539
    - Recruiting
    - Saint Louis University Cancer Center /ID# 222287
- New Jersey
  - Florham Park, New Jersey, United States, 07932-1049
    - Recruiting
    - Summit Medical Group-Florham Park /ID# 222620
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack Univ Med Ctr /ID# 219047
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
- New York
  - Greenvale, New York, United States, 11548-1219
    - Recruiting
    - The Cancer Institute at St. Francis Hospital /ID# 231782
  - New York, New York, United States, 10016-6028
    - Recruiting
    - Manhattan Hematology Oncology MHO Associates /ID# 223193
  - New York, New York, United States, 10065-6007
    - Recruiting
    - Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081
- North Carolina
  - Winston-Salem, North Carolina, United States, 27157-0001
    - Recruiting
    - Wake Forest Baptist Medical Center /ID# 222899
- Ohio
  - Cleveland, Ohio, United States, 44109
    - Recruiting
    - MetroHealth Medical Center /ID# 222650
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104-4238
    - Recruiting
    - Hospital of the University of Pennsylvania /ID# 219001
    - Contact:
      
      Site Coordinator
      
      Phone Number: 844-663-3742
  - Philadelphia, Pennsylvania, United States, 19111
    - Completed
    - Fox Chase Cancer Center /ID# 223955
- Texas
  - Houston, Texas, United States, 77030
    - Completed
    - Houston Methodist Hospital /ID# 223103
  - San Antonio, Texas, United States, 78229
    - Completed
    - University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942
- Utah
  - Salt Lake City, Utah, United States, 84106
    - Recruiting
    - Utah Cancer Specialists Salt Lake Clinic /ID# 221962
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Recruiting
    - Virginia Cancer Specialists - Fairfax /ID# 223016
- Washington
  - Everett, Washington, United States, 98201
    - Completed
    - Providence Everett /ID# 223130
  - Yakima, Washington, United States, 98902-6388
    - Recruiting
    - Yakima Valley Memorial Hosp /ID# 224368
- Wisconsin
  - Green Bay, Wisconsin, United States, 54301
    - Recruiting
    - HSHS St. Vincent Hospital /ID# 224468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.
-- Has at least 2 symptoms each with an average score >= 3 or an average total score of >= 12, as measured by the MFSAF v4.0.
Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.
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 lack 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 treatment with ruxolitinib of at least 10 mg twice daily (BID) 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.

Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Splenomegaly defined as palpable spleen measurement >= 5 cm below left 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 or stem cell transplant.
Eligible for stem cell transplantation at the time of study entry.
Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 mg daily) and low molecular weight heparin (LMWH).
Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Navitoclax + Ruxolitinib Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.	Drug: Ruxolitinib Tablet; Oral Drug: Navitoclax Tablet; Oral Other Names: ABT-263
Active Comparator: Arm B: Best Available Therapy (BAT) Participants will receive one of the BAT options, per the investigator's discretion.	Drug: Best Available Therapy (BAT) Tablet/Capsule; Oral or Solution for Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Week 0) Up to Week 24
Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time Time Frame: Baseline (Week 0) Up to Week 97	Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.	Baseline (Week 0) Up to Week 97
Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis Time Frame: Baseline (Week 0) Up to Week 97	Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.	Baseline (Week 0) Up to Week 97
Percentage of Participants with Anemia Response Time Frame: Baseline (Week 0) Up to Week 97	Anemia response per International Working Group (IWG) criteria will be assessed.	Baseline (Week 0) Up to Week 97
Percentage of Participants with Overall Survival Time Frame: Last Visit Up to 5 Years	Overall survival is defined as the time from start of study to the date of death from any cause.	Last Visit Up to 5 Years
Percentage of Participants with Leukemia-free Survival Time Frame: Last Visit Up to 5 Years	Leukemia free survival is the time from start of study to the date of development of leukemia.	Last Visit Up to 5 Years
Percentage of Participants with 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.	Baseline (Week 0) Up to Week 24
Time to Deterioration of Physical Functioning Time Frame: Baseline (Week 0) Up to Week 97	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.	Baseline (Week 0) Up to Week 97
Percentage of Participants with at Least 50% Reduction in TSS Time Frame: Baseline (Week 0) Up to Week 97	At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.	Baseline (Week 0) Up to Week 97

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

November 3, 2031

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M20-178
2020-000557-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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Clinical Trials on Ruxolitinib

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