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
NCT ID: NCT04472598
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
252 participants
INTERVENTIONAL
2020-09-29
2025-01-29
Brief Summary
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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 190 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 untill 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) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Navitoclax + Ruxolitinib
Participants will receive Navitoclax in combination with Ruxolitinib
Navitoclax
Tablet; Oral
Ruxolitinib
Tablet; Oral
Placebo for Navitoclax + Ruxolitinib
Participants will receive placebo for Navitoclax and Ruxolitinib
Ruxolitinib
Tablet; Oral
Placebo for Navitoclax
Tablet; Oral
Interventions
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Navitoclax
Tablet; Oral
Ruxolitinib
Tablet; Oral
Placebo for Navitoclax
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days immediately preceding the date of 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 and other criteria per National Comprehensive Cancer Network guidelines.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion Criteria
* Prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor or stem cell transplant.
* 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 milligram daily) and low molecular weight heparin (LMWH).
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Highlands Oncology Group, PA /ID# 221824
Springdale, Arkansas, United States
Providence - St. Jude Medical Center /ID# 241646
Fullerton, California, United States
Moores Cancer Center at UC San Diego /ID# 218012
La Jolla, California, United States
Rocky Mountain Cancer Centers - Littleton /ID# 222562
Littleton, Colorado, United States
Lynn Cancer Institute, Boca /ID# 230687
Boca Raton, Florida, United States
Florida Cancer Specialist - South /ID# 221726
Fort Myers, Florida, United States
Florida Cancer Specialists - North /ID# 221727
St. Petersburg, Florida, United States
Florida Cancer Specialists - East /ID# 221728
West Palm Beach, Florida, United States
Emory University /ID# 221562
Atlanta, Georgia, United States
Augusta University Georgia Cancer Center /ID# 221551
Augusta, Georgia, United States
Columbus Regional Research Institute /ID# 227272
Columbus, Georgia, United States
Duplicate_Rush University Medical Center /ID# 221581
Chicago, Illinois, United States
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
Normal, Illinois, United States
Indiana Blood & Marrow Transpl /ID# 221586
Indianapolis, Indiana, United States
University of Kansas Cancer Center /ID# 218144
Fairway, Kansas, United States
Massachusetts General Hospital /ID# 221559
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center /ID# 224261
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 218010
Boston, Massachusetts, United States
University of Michigan /ID# 221658
Ann Arbor, Michigan, United States
Minnesota Oncology Hematology /ID# 227357
Edina, Minnesota, United States
MidAmerica Division, Inc. /ID# 221743
Kansas City, Missouri, United States
Hackensack Univ Med Ctr /ID# 221654
Hackensack, New Jersey, United States
Northwell Health - Monter Cancer Center /ID# 222996
Lake Success, New York, United States
Weill Cornell Medical College /ID# 220933
New York, New York, United States
Gabrail Cancer Center Research /ID# 230488
Canton, Ohio, United States
Oncology Hematology Care, Inc. /ID# 222556
Cincinnati, Ohio, United States
The Ohio State University /ID# 221584
Columbus, Ohio, United States
UPMC Hillman Cancer Ctr /ID# 218134
Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Ctr /ID# 231689
Knoxville, Tennessee, United States
University of Texas MD Anderson Cancer Center /ID# 217994
Houston, Texas, United States
Texas Oncology - Northeast Texas /ID# 241813
Tyler, Texas, United States
Utah Cancer Specialists Salt Lake Clinic /ID# 221961
Salt Lake City, Utah, United States
University of Utah /ID# 221009
Salt Lake City, Utah, United States
Virginia Cancer Specialists - Fairfax /ID# 242682
Fairfax, Virginia, United States
VA Puget Sound Health Care System /ID# 231691
Seattle, Washington, United States
The Kinghorn Cancer Centre /ID# 221503
Darlinghurst, New South Wales, Australia
Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 231311
East Albury, New South Wales, Australia
Gosford Hospital /ID# 221499
Gosford, New South Wales, Australia
Liverpool Hospital /ID# 221803
Liverpool, New South Wales, Australia
Townsville University Hospital /ID# 229794
Douglas, Queensland, Australia
Peter MacCallum Cancer Ctr /ID# 229795
Melbourne, Victoria, Australia
The Alfred Hospital /ID# 221501
Melbourne, Victoria, Australia
Royal Perth Hospital /ID# 223203
Perth, Western Australia, Australia
Duplicate_Medizinische Universitaet Graz /ID# 220910
Graz, Styria, Austria
Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 220901
Wels, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 220906
Vienna, Vienna, Austria
Hanusch Krankenhaus /ID# 220909
Vienna, , Austria
ZAS Cadix /ID# 221465
Antwerp, Antwerpen, Belgium
CHU de Liège /ID# 218874
Liège, Liege, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 221127
Yvoir, Namur, Belgium
UZ Gent /ID# 221125
Ghent, Oost-Vlaanderen, Belgium
Vitaz /Id# 229861
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 218806
Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 221466
Roeselare, West-Vlaanderen, Belgium
AZ Sint-Jan Brugge /ID# 218805
Bruges, , Belgium
UMHAT Alexandrovska EAD /ID# 231056
Sofiya, Sofia, Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 231161
Pleven, , Bulgaria
UMHAT Sveti Georgi /ID# 231053
Plovdiv, , Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036
Sofia, , Bulgaria
UMHAT Sveti Ivan Rilski /ID# 231028
Sofia, , Bulgaria
Royal Victoria Hospital /ID# 222636
Barrie, Ontario, Canada
Juravinski Cancer Centre /ID# 221752
Hamilton, Ontario, Canada
Lakeridge Health - Oshawa /ID# 222080
Oshawa, Ontario, Canada
Niagara Health System /ID# 230994
St. Catharines, Ontario, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
Québec, Quebec, Canada
Clinical Hospital Dubrava /ID# 230795
Zagreb, City of Zagreb, Croatia
Klinicka bolnica Merkur /ID# 231155
Zagreb, City of Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 230793
Zagreb, City of Zagreb, Croatia
Duplicate_Klinicki bolnicki centar Split /ID# 230796
Split, Split-Dalmatia County, Croatia
CHU NIMES - Hopital Caremeau /ID# 219114
Nîmes, Gard, France
Centre Hospitalier Universitaire de Bordeaux /ID# 222518
Pessac, Gironde, France
CH Roubaix - Hopital Victor Provo /ID# 219116
Roubaix, Hauts-de-France, France
CHU de Nantes, Hotel Dieu -HME /ID# 219113
Nantes, Pays de la Loire Region, France
HCL - Hopital Lyon Sud /ID# 222913
Pierre-Bénite, Rhone, France
Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 224506
Chambéry, Savoie, France
Chu Angers /Id# 219115
Angers, , France
Hôpital Saint-Louis /ID# 221288
Paris, , France
AP-HP - Hopital Necker /ID# 231318
Paris, , France
ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978
Strasbourg, , France
Hopital Avicenne - APHP /ID# 221286
Bobigny, Île-de-France Region, France
Universitatsklinikum Mannheim /ID# 221523
Mannheim, Baden-Wurttemberg, Germany
Haemato-Onkologie /ID# 221061
Munich, Bavaria, Germany
Universitaetsklinikum Aachen /ID# 221519
Aachen, North Rhine-Westphalia, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
Dresden, Saxony, Germany
Universitaetsklinikum Essen /ID# 221522
Essen, , Germany
OncoResearch Lerchenfeld GmbH /ID# 230867
Hamburg, , Germany
Klinikum rechts der Isar /ID# 221520
Munich, , Germany
General Hospital of Athens Laiko /ID# 230785
Athens, Attica, Greece
Duplicate_University General Hospital Attikon /ID# 230784
Athens, Attica, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
Athens, , Greece
Meir Medical Center /ID# 221374
Kfar Saba, Central District, Israel
Yitzhak Shamir Medical Center /ID# 222957
Ẕerifin, Central District, Israel
Rambam Health Care Campus /ID# 219120
Haifa, H_efa, Israel
Hadassah Medical Center-Hebrew University /ID# 219110
Jerusalem, Jerusalem, Israel
The Chaim Sheba Medical Center /ID# 219137
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 219134
Tel Aviv, Tel Aviv, Israel
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 220867
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 219086
Florence, Firenze, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083
Rome, Roma, Italy
ASST Papa Giovanni XXIII /ID# 221907
Bergamo, , Italy
ASST degli Spedali Civili di Brescia /ID# 241273
Brescia, , Italy
AOU Policlinico G. Rodolico - San Marco /ID# 219085
Catania, , Italy
Duplicate_ASST Sette Laghi /ID# 219084
Varese, , Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital /ID# 221537
Toyoake, Aichi-ken, Japan
Duplicate_Chiba University Hospital /ID# 239345
Chiba, Chiba, Japan
National Cancer Center Hospital East /ID# 226093
Kashiwa-shi, Chiba, Japan
Ehime University Hospital /ID# 221443
Toon-shi, Ehime, Japan
Kyushu University Hospital /ID# 221783
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 222752
Fukushima, Fukushima, Japan
Ogaki Municipal Hospital /ID# 240173
Ogaki-shi, Gifu, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 242806
Maebashi, Gunma, Japan
Gunma University Hospital /ID# 221480
Maebashi, Gunma, Japan
Duplicate_Hokkaido University Hospital /ID# 242667
Sapporo, Hokkaido, Japan
Kobe University Hospital /ID# 246236
Kobe, Hyōgo, Japan
Hitachi General Hospital /ID# 240048
Hitachi-shi, Ibaraki, Japan
Kanazawa University Hospital /ID# 238424
Kanazawa, Ishikawa-ken, Japan
Medical Corporation Seijinkai Ikeda Hospital /ID# 242172
Kanoya-shi, Kagoshima-ken, Japan
Kyoto University Hospital /ID# 238423
Kyoto, Kyoto, Japan
Mie University Hospital /ID# 221664
Tsu, Mie-ken, Japan
University of Miyazaki Hospital /ID# 221483
Miyazaki, Miyazaki, Japan
Duplicate_Kawasaki Medical School Hospital /ID# 221481
Kurashiki-shi, Okayama-ken, Japan
Kurashiki Central Hospital /ID# 221692
Kurashiki-shi, Okayama-ken, Japan
Kansai Medical University Hospital /ID# 221482
Hirakata-shi, Osaka, Japan
Kindai University Hospital /ID# 221479
Osakasayama-shi, Osaka, Japan
Osaka University Hospital /ID# 221478
Suita-shi, Osaka, Japan
Dokkyo Medical University Saitama Medical Center /ID# 222333
Koshigaya, Saitama, Japan
Juntendo University Shizuoka Hospital /ID# 221782
Izunokuni-shi, Shizuoka, Japan
Juntendo University Hospital /ID# 221405
Bunkyo-ku, Tokyo, Japan
Nippon Medical School Hospital /ID# 221674
Bunkyo-ku, Tokyo, Japan
University of Yamanashi Hospital /ID# 221701
Chuo-shi, Yamanashi, Japan
Radboud Universitair Medisch Centrum /ID# 218948
Nijmegen, Gelderland, Netherlands
Albert Schweitzer Ziekenhuis /ID# 224015
Dordrecht, South Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 218947
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 218949
Utrecht, , Netherlands
Aotearoa Clinical Trials /ID# 230770
Papatoetoe, Auckland, New Zealand
Moscow State budget healthcare /ID# 221025
Moscow, Moscow, Russia
Republican hospital named after V.A. Baranov /ID# 221412
Petrozavodsk, Murmansk Oblast, Russia
Clinic UZI 4D /ID# 221024
Pyatigorsk, Stavropol Kray, Russia
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029
Saint Petersburg, , Russia
Leningrad Regional Clinical Hospital /ID# 221028
Saint Petersburg, , Russia
Almazov National Medical Research Centre /ID# 221033
Saint Petersburg, , Russia
Tula Regional Clinical Hospital /ID# 221027
Tula, , Russia
University Clinical Center Serbia /ID# 230854
Belgrade, Beograd, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 230946
Belgrade, Beograd, Serbia
University Clinical Center Kragujevac /ID# 230855
Kragujevac, Pomoravski Okrug, Serbia
Duplicate_Clinical Center Vojvodina /ID# 230853
Novi Sad, Vojvodina, Serbia
Wits Clinical Research /ID# 232072
Johannesburg, Gauteng, South Africa
Duplicate_Wits Clinical Research Site /ID# 232071
Johannesburg, Gauteng, South Africa
Alberts Cellular Therapy /ID# 232073
Pretoria, Gauteng, South Africa
Duplicate_Inje University Busan Paik Hospital /ID# 231667
Busan, Busan Gwang Yeogsi, South Korea
Pusan National University Hospital /ID# 222087
Busan, Busan Gwang Yeogsi, South Korea
Duplicate_Kyungpook National University Hospital /ID# 231666
Daegu, Daegu Gwang Yeogsi, South Korea
Gachon University Gil Medical Center /ID# 222089
Incheon, Gyeonggido, South Korea
Duplicate_Seoul National University Bundang Hospital /ID# 219053
Seongnam, Gyeonggido, South Korea
Seoul National University Hospital /ID# 219055
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center /ID# 219054
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 221068
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219056
Seoul, Seoul Teugbyeolsi, South Korea
Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Germans Trias i Pujol /ID# 229936
Badalona, Barcelona, Spain
Hospital Universitario Dr. Negrin /ID# 220897
Las Palmas de Gran Canaria, Las Palmas, Spain
Clinica Universidad de Navarra - Pamplona /ID# 230720
Pamplona, Navarre, Spain
Hospital Parc de Salut del Mar /ID# 220913
Barcelona, , Spain
Hospital Universitario Vall d'Hebron /ID# 229690
Barcelona, , Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
Madrid, , Spain
Hospital Universitario Ramon y Cajal /ID# 220877
Madrid, , Spain
Hospital Universitario 12 de Octubre /ID# 229691
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 220878
Málaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 220875
Valencia, , Spain
Duplicate_Skane University Hospital Lund /ID# 220835
Lund, Skåne County, Sweden
Duplicate_Sahlgrenska University Hospital /ID# 218776
Gothenburg, Västra Götaland County, Sweden
Orebro Universitetssjukhuset /ID# 220829
Örebro, Örebro County, Sweden
Kaohsiung Chang Gung Memorial Hospital /ID# 218984
Kaohsiung City, Kaohsiung, Taiwan
Chi Mei Hospital - Liouying /ID# 221145
Tainan City, Tainan, Taiwan
National Taiwan University Hospital /ID# 218976
Taipei City, Taipei, Taiwan
China Medical University Hospital /ID# 218978
Taichung, , Taiwan
Taipei Veterans General Hosp /ID# 221146
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 218983
Taoyuan, , Taiwan
Hacettepe University Medical Faculty /ID# 230759
Ankara, , Turkey (Türkiye)
Trakya University Medical Facu /ID# 230754
Edirne, Istanbul, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty /ID# 230753
Izmir, , Turkey (Türkiye)
Inonu University Medical Faculty /ID# 230758
Malatya, , Turkey (Türkiye)
Communal non-profit enterprise Regional Center of Oncology /ID# 230832
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 230834
Kyiv, , Ukraine
Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370
Kyiv, , Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833
Lviv, , Ukraine
Guys and St Thomas NHS Foundation Trust /ID# 219185
London, Greater London, United Kingdom
United Lincolnshire Hospitals NHS Trust /ID# 231471
Lincoln, Lincolnshire, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 219192
Oxford, Oxfordshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 221333
Birmingham, , United Kingdom
The Christie Hospital /ID# 219191
Manchester, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2020-000097-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-191
Identifier Type: -
Identifier Source: org_study_id
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