Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)
Study ID: NCT04472598
Conditions
Study Description
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 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Highlands Oncology Group, PA /ID# 221824, Springdale, Arkansas, United States
Providence Medical Foundation /ID# 241646, Fullerton, California, United States
Moores Cancer Center at UC San Diego /ID# 218012, La Jolla, California, United States
Rocky Mountain Cancer Centers, LLP- 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, Saint 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
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 Comprehensive Cancer Center Michigan Medicine /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 Regional Cancer Centre /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
Alfred Health /ID# 221501, Melbourne, Victoria, Australia
Royal Perth Hospital /ID# 223203, Perth, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 220813, Linz, Oberoesterreich, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 220901, Wels, Oberoesterreich, Austria
Medizinische Universitaet Graz /ID# 220910, Graz, Steiermark, Austria
Medizinische Universitaet Wien /ID# 220906, Vienna, Wien, Austria
Hanusch Krankenhaus /ID# 220909, Wien, , Austria
CHU UCL Namur - site Godinne /ID# 221127, Godinne, Namur, Belgium
UZ Gent /ID# 221125, Gent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 218806, Leuven, Vlaams-Brabant, Belgium
AZ-Delta /ID# 221466, Roeselare, West-Vlaanderen, Belgium
ZNA Stuivenberg /ID# 221465, Antwerp, , Belgium
AZ Sint-Jan Brugge /ID# 218805, Brugge, , Belgium
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874, Liege, , Belgium
Vitaz /Id# 229861, Sint-Niklaas, , 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, Quebec City, Quebec, Canada
Clinical Hospital Dubrava /ID# 230795, Zagreb, Grad Zagreb, Croatia
Klinicka bolnica Merkur /ID# 231155, Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Zagreb /ID# 230793, Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Split /ID# 230796, Split, Splitsko-dalmatinska Zupanija, Croatia
HCL - Hopital Lyon Sud /ID# 222913, Pierre Benite CEDEX, Auvergne-Rhone-Alpes, France
CHU NIMES - Hopital Caremeau /ID# 219114, Nimes CEDEX 9, Gard, France
CHU Bordeaux - Hopital Haut Leveque /ID# 222518, Pessac, Gironde, France
CH Roubaix - Hopital Victor Provo /ID# 219116, Roubaix Cedex 1, Hauts-de-France, France
Hopital Avicenne - APHP /ID# 221286, Bobigny, Ile-de-France, France
CHU de Nantes, Hotel Dieu -HME /ID# 219113, Nantes, Pays-de-la-Loire, France
Centre Hospitalier de CHAMBERY /ID# 224506, Chambery, Savoie, France
Chu Angers /Id# 219115, Angers, , France
AP-HP - Hopital Saint-Louis /ID# 221288, Paris, , France
AP-HP - Hopital Necker /ID# 231318, Paris, , France
ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978, Strasbourg Cedex, , France
Universitatsklinikum Mannheim /ID# 221523, Mannheim, Baden-Wuerttemberg, Germany
Haemato-Onkologie /ID# 221061, Muenchen, Bayern, Germany
Universitaetsklinikum Aachen /ID# 221519, Aachen, Nordrhein-Westfalen, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347, Dresden, Sachsen, Germany
Universitaetsklinikum Essen /ID# 221522, Essen, , Germany
OncoResearch Lerchenfeld GmbH /ID# 230867, Hamburg, , Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520, Munich, , Germany
General Hospital of Athens Laiko /ID# 230785, Athens, Attiki, Greece
University General Hospital Attikon /ID# 230784, Athens, Attiki, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786, Athens, , Greece
The Chaim Sheba Medical Center /ID# 219137, Ramat Gan, Tel-Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 219134, Tel Aviv-Yafo, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 219110, Jerusalem, Yerushalayim, Israel
Assaf Harofeh Medical Center /ID# 222957, Be'Er Ya'Akov, , Israel
Rambam Health Care Campus /ID# 219120, Haifa, , Israel
Meir Medical Center /ID# 221374, Kfar Saba, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083, Rome, Lazio, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907, Bergamo, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867, Bologna, , Italy
ASST Spedali civili di Brescia /ID# 241273, Brescia, , Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085, Catania, , Italy
Azienda Ospedaliero Universitaria Careggi /ID# 219086, Florence, , Italy
ASST Sette Laghi /ID# 219084, Varese, , Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100, Nagoya-shi, Aichi, Japan
Fujita Health University Hospital /ID# 221537, Toyoake-shi, Aichi, Japan
Chiba University Hospital /ID# 239345, Chiba-shi, 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-shi, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 222752, Fukushima-shi, Fukushima, Japan
Ogaki Municipal Hospital /ID# 240173, Ogaki-shi, Gifu, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 242806, Maebashi-shi, Gunma, Japan
Gunma University Hospital /ID# 221480, Maebashi-shi, Gunma, Japan
Hokkaido University Hospital /ID# 242667, Sapporo-shi, Hokkaido, Japan
Kobe University Hospital /ID# 246236, Kobe-shi, Hyogo, Japan
Hitachi General Hospital /ID# 240048, Hitachi-shi, Ibaraki, Japan
Kanazawa University Hospital /ID# 238424, Kanazawa-shi, Ishikawa, Japan
Medical Corporation Seijinkai Ikeda Hospital /ID# 242172, Kanoya-shi, Kagoshima, Japan
Kyoto University Hospital /ID# 238423, Kyoto-shi, Kyoto, Japan
Mie University Hospital /ID# 221664, Tsu-shi, Mie, Japan
University of Miyazaki Hospital /ID# 221483, Miyazaki-shi, Miyazaki, Japan
Kawasaki Medical School Hospital /ID# 221481, Kurashiki-shi, Okayama, Japan
Kurashiki Central Hospital /ID# 221692, Kurashiki-shi, Okayama, 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-shi, 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
Seoul National University Bundang Hospital /ID# 219053, Seongnam, Gyeonggido, Korea, Republic of
Inje University Busan Paik Hospital /ID# 231667, Busan, , Korea, Republic of
Pusan National University Hospital /ID# 222087, Busan, , Korea, Republic of
Kyungpook National University Hospital /ID# 231666, Daegu, , Korea, Republic of
Gachon University Gil Medical Center /ID# 222089, Incheon, , Korea, Republic of
Seoul National University Hospital /ID# 219055, Seoul, , Korea, Republic of
Asan Medical Center /ID# 219054, Seoul, , Korea, Republic of
Samsung Medical Center /ID# 221068, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056, Seoul, , Korea, Republic of
Radboud Universitair Medisch Centrum /ID# 218948, Nijmegen, Gelderland, Netherlands
Albert Schweitzer Ziekenhuis /ID# 224015, Dordrecht, Zuid-Holland, Netherlands
Universitair Medisch Centrum Groningen /ID# 218947, Groningen, , Netherlands
Universitair Medisch Centrum Utrecht /ID# 218949, Utrecht, , Netherlands
Middlemore Clinical Trials /ID# 230770, Papatoetoe, Auckland, New Zealand
Moscow State budget healthcare /ID# 221025, Moscow, Moskva, Russian Federation
Clinic UZI 4D /ID# 221024, Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Republican hospital named after V.A. Baranov /ID# 221412, Petrozavodsk, , Russian Federation
Leningrad Regional Clinical Hospital /ID# 221028, Saint Petersburg, , Russian Federation
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029, Sankt-Peterburg, , Russian Federation
Almazov National Medical Research Centre /ID# 221033, Sankt-Peterburg, , Russian Federation
Tula Regional Clinical Hospital /ID# 221027, Tula, , Russian Federation
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, Sumadijski Okrug, Serbia
Clinical Center Vojvodina /ID# 230853, Novi Sad, Vojvodina, Serbia
Wits Clinical Research Site /ID# 232071, Johannesburg, Gauteng, South Africa
Wits Clinical Research Site /ID# 232072, Johannesburg, Gauteng, South Africa
Albert Alberts Stem Cell Transplant Centre /ID# 232073, Pretoria, Gauteng, South Africa
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, Navarra, 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, Malaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 220875, Valencia, , Spain
Orebro Universitetssjukhuset /ID# 220829, Orebro, Orebro Lan, Sweden
Skane University Hospital Lund /ID# 220835, Lund, Skane Lan, Sweden
Sahlgrenska University Hospital /ID# 218776, Gothenburg, Vastra Gotalands Lan, Sweden
Kaohsiung Chang Gung Memorial Hospital /ID# 218984, Kaohsiung City, Kaohsiung, Taiwan
China Medical University Hospital /ID# 218978, Taichung City, , Taiwan
Chi Mei Hospital - Liouying /ID# 221145, Tainan City, , Taiwan
National Taiwan University Hospital /ID# 218976, Taipei City, , Taiwan
Taipei Veterans General Hosp /ID# 221146, Taipei City, , Taiwan
Linkou Chang Gung Memorial Hospital /ID# 218983, Taoyuan City, , Taiwan
Hacettepe University Medical Faculty /ID# 230759, Ankara, , Turkey
Trakya University Medical Facu /ID# 230754, Edirne, Istanbul, , Turkey
Bagcilar Medipol Mega Universite Hastanesi /ID# 230757, Istanbul, , Turkey
Ege University Medical Faculty /ID# 230753, Izmir, , Turkey
Inonu University Medical Faculty /ID# 230758, Malatya, , Turkey
Communal non-profit enterprise Regional Center of Oncology /ID# 230832, Kharkiv, , Ukraine
Medical Center "OK!Clinic+" /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
United Lincolnshire Hospitals NHS Trust /ID# 231471, Lincoln, Lincolnshire, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 219185, London, London, City Of, 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
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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