Myeloproliferative Neoplasms Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) .

Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days prior to randomization.

-- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.

Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant 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 Janus Kinase-2 (JAK-2) inhibitor.
Prior treatment with a 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).

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

252

Study ID:

NCT04472598

Recruitment Status:

Active, not recruiting

Sponsor:

AbbVie

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There are 186 Locations for this study

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Highlands Oncology Group, PA /ID# 221824
Springdale Arkansas, 72762, United States
Providence Medical Foundation /ID# 241646
Fullerton California, 92835, United States
Moores Cancer Center at UC San Diego /ID# 218012
La Jolla California, 92093, United States
Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562
Littleton Colorado, 80120, United States
Lynn Cancer Institute, Boca /ID# 230687
Boca Raton Florida, 33486, United States
Florida Cancer Specialist - South /ID# 221726
Fort Myers Florida, 33901, United States
Florida Cancer Specialists - North /ID# 221727
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists - East /ID# 221728
West Palm Beach Florida, 33401, United States
Emory University /ID# 221562
Atlanta Georgia, 30322, United States
Augusta University Georgia Cancer Center /ID# 221551
Augusta Georgia, 30912, United States
Columbus Regional Research Institute /ID# 227272
Columbus Georgia, 31904, United States
Rush University Medical Center /ID# 221581
Chicago Illinois, 60612, United States
Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204
Normal Illinois, 61761, United States
Indiana Blood & Marrow Transpl /ID# 221586
Indianapolis Indiana, 46237, United States
University of Kansas Cancer Center /ID# 218144
Fairway Kansas, 66205, United States
Massachusetts General Hospital /ID# 221559
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center /ID# 224261
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute /ID# 218010
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658
Ann Arbor Michigan, 48109, United States
Minnesota Oncology Hematology /ID# 227357
Edina Minnesota, 55435, United States
MidAmerica Division, Inc. /ID# 221743
Kansas City Missouri, 64132, United States
Hackensack Univ Med Ctr /ID# 221654
Hackensack New Jersey, 07601, United States
Northwell Health - Monter Cancer Center /ID# 222996
Lake Success New York, 11042, United States
Weill Cornell Medical College /ID# 220933
New York New York, 10065, United States
Gabrail Cancer Center Research /ID# 230488
Canton Ohio, 44718, United States
Oncology Hematology Care, Inc. /ID# 222556
Cincinnati Ohio, 45236, United States
The Ohio State University /ID# 221584
Columbus Ohio, 43210, United States
UPMC Hillman Cancer Ctr /ID# 218134
Pittsburgh Pennsylvania, 15232, United States
Thompson Cancer Survival Ctr /ID# 231689
Knoxville Tennessee, 37916, United States
University of Texas MD Anderson Cancer Center /ID# 217994
Houston Texas, 77030, United States
Texas Oncology - Northeast Texas /ID# 241813
Tyler Texas, 75702, United States
Utah Cancer Specialists Salt Lake Clinic /ID# 221961
Salt Lake City Utah, 84106, United States
University of Utah /ID# 221009
Salt Lake City Utah, 84112, United States
Virginia Cancer Specialists - Fairfax /ID# 242682
Fairfax Virginia, 22031, United States
VA Puget Sound Health Care System /ID# 231691
Seattle Washington, 98108, United States
The Kinghorn Cancer Centre /ID# 221503
Darlinghurst New South Wales, 2010, Australia
Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311
East Albury New South Wales, 2640, Australia
Gosford Hospital /ID# 221499
Gosford New South Wales, 2250, Australia
Liverpool Hospital /ID# 221803
Liverpool New South Wales, 2170, Australia
Townsville University Hospital /ID# 229794
Douglas Queensland, 4814, Australia
Peter MacCallum Cancer Ctr /ID# 229795
Melbourne Victoria, 3000, Australia
Alfred Health /ID# 221501
Melbourne Victoria, 3004, Australia
Royal Perth Hospital /ID# 223203
Perth Western Australia, 6000, Australia
Ordensklinikum Linz GmbH Elisabethinen /ID# 220813
Linz Oberoesterreich, 4010, Austria
Klinikum Wels-Grieskirchen GmbH /ID# 220901
Wels Oberoesterreich, 4600, Austria
Medizinische Universitaet Graz /ID# 220910
Graz Steiermark, 8036, Austria
Medizinische Universitaet Wien /ID# 220906
Vienna Wien, 1090, Austria
Hanusch Krankenhaus /ID# 220909
Wien , 1140, Austria
CHU UCL Namur - site Godinne /ID# 221127
Godinne Namur, 5530, Belgium
UZ Gent /ID# 221125
Gent Oost-Vlaanderen, 9000, Belgium
Universitair Ziekenhuis Leuven /ID# 218806
Leuven Vlaams-Brabant, 3000, Belgium
ZNA Stuivenberg /ID# 221465
Antwerp , 2060, Belgium
AZ Sint-Jan Brugge /ID# 218805
Brugge , 8000, Belgium
Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874
Liege , 4000, Belgium
AZ-Delta /ID# 221466
Roeselare , 8800, Belgium
Vitaz /Id# 229861
Sint-Niklaas , 9100, Belgium
UMHAT Alexandrovska EAD /ID# 231056
Sofiya Sofia, 1431, Bulgaria
UMHAT Dr Georgi Stranski EAD /ID# 231161
Pleven , 5800, Bulgaria
UMHAT Sveti Georgi /ID# 231053
Plovdiv , 4002, Bulgaria
Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036
Sofia , 1407, Bulgaria
UMHAT Sveti Ivan Rilski /ID# 231028
Sofia , 1431, Bulgaria
Royal Victoria Hospital /ID# 222636
Barrie Ontario, L4M 6, Canada
Juravinski Cancer Centre /ID# 221752
Hamilton Ontario, L8V 1, Canada
Lakeridge Health - Oshawa /ID# 222080
Oshawa Ontario, L1G 2, Canada
Niagara Health System /ID# 230994
St Catharines Ontario, L2S 0, Canada
CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754
Quebec City Quebec, G1J 1, Canada
Clinical Hospital Dubrava /ID# 230795
Zagreb Grad Zagreb, 10000, Croatia
Klinicka bolnica Merkur /ID# 231155
Zagreb Grad Zagreb, 10000, Croatia
Klinicki bolnicki centar Zagreb /ID# 230793
Zagreb Grad Zagreb, 10000, Croatia
Klinicki bolnicki centar Split /ID# 230796
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
HCL - Hopital Lyon Sud /ID# 222913
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
CHU NIMES - Hopital Caremeau /ID# 219114
Nimes CEDEX 9 Gard, 30029, France
CHU Bordeaux - Hopital Haut Leveque /ID# 222518
Pessac Gironde, 33604, France
CH Roubaix - Hopital Victor Provo /ID# 219116
Roubaix Cedex 1 Hauts-de-France, 59100, France
Hopital Avicenne - APHP /ID# 221286
Bobigny Ile-de-France, 93000, France
CHU de Nantes, Hotel Dieu -HME /ID# 219113
Nantes Pays-de-la-Loire, 44000, France
Chu Angers /Id# 219115
Angers , 49933, France
Centre Hospitalier de CHAMBERY /ID# 224506
Chambery , 73000, France
AP-HP - Hopital Saint-Louis /ID# 221288
Paris , 75010, France
AP-HP - Hopital Necker /ID# 231318
Paris , 75015, France
ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978
Strasbourg Cedex , 67033, France
Universitatsklinikum Mannheim /ID# 221523
Mannheim Baden-Wuerttemberg, 68167, Germany
Haemato-Onkologie /ID# 221061
Muenchen Bayern, 81241, Germany
Universitaetsklinikum Aachen /ID# 221519
Aachen Nordrhein-Westfalen, 52074, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347
Dresden Sachsen, 01307, Germany
Universitaetsklinikum Essen /ID# 221522
Essen , 45147, Germany
OncoResearch Lerchenfeld GmbH /ID# 230867
Hamburg , 22081, Germany
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520
Munich , 81675, Germany
General Hospital of Athens Laiko /ID# 230785
Athens Attiki, 11527, Greece
University General Hospital Attikon /ID# 230784
Athens Attiki, 12462, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786
Athens , 10676, Greece
The Chaim Sheba Medical Center /ID# 219137
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv Sourasky Medical Center /ID# 219134
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Hadassah Medical Center-Hebrew University /ID# 219110
Jerusalem Yerushalayim, 91120, Israel
Assaf Harofeh Medical Center /ID# 222957
Be'Er Ya'Akov , 70300, Israel
Rambam Health Care Campus /ID# 219120
Haifa , 31096, Israel
Meir Medical Center /ID# 221374
Kfar Saba , 44281, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083
Rome Lazio, 00168, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907
Bergamo , 24127, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867
Bologna , 40138, Italy
ASST Spedali civili di Brescia /ID# 241273
Brescia , 25123, Italy
A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085
Catania , 95123, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 219086
Florence , 50134, Italy
ASST Sette Laghi /ID# 219084
Varese , 21100, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100
Nagoya-shi Aichi, 453-8, Japan
Fujita Health University Hospital /ID# 221537
Toyoake-shi Aichi, 470-1, Japan
Chiba University Hospital /ID# 239345
Chiba-shi Chiba, 260-8, Japan
National Cancer Center Hospital East /ID# 226093
Kashiwa-shi Chiba, 277-8, Japan
Ehime University Hospital /ID# 221443
Toon-shi Ehime, 791-0, Japan
Kyushu University Hospital /ID# 221783
Fukuoka-shi Fukuoka, 812-8, Japan
Fukushima Medical University Hospital /ID# 222752
Fukushima-shi Fukushima, 960-1, Japan
Ogaki Municipal Hospital /ID# 240173
Ogaki-shi Gifu, 503-8, Japan
Gunmaken Saiseikai Maebashi Hospital /ID# 242806
Maebashi-shi Gunma, 371-0, Japan
Gunma University Hospital /ID# 221480
Maebashi-shi Gunma, 371-8, Japan
Hokkaido University Hospital /ID# 242667
Sapporo-shi Hokkaido, 060-8, Japan
Kobe University Hospital /ID# 246236
Kobe-shi Hyogo, 650-0, Japan
Hitachi General Hospital /ID# 240048
Hitachi-shi Ibaraki, 317-0, Japan
Kanazawa University Hospital /ID# 238424
Kanazawa-shi Ishikawa, 920-8, Japan
Medical Corporation Seijinkai Ikeda Hospital /ID# 242172
Kanoya-shi Kagoshima, 893-0, Japan
Kyoto University Hospital /ID# 238423
Kyoto-shi Kyoto, 606-8, Japan
Mie University Hospital /ID# 221664
Tsu-shi Mie, 514-8, Japan
University of Miyazaki Hospital /ID# 221483
Miyazaki-shi Miyazaki, 889-1, Japan
Kawasaki Medical School Hospital /ID# 221481
Kurashiki-shi Okayama, 701-0, Japan
Kurashiki Central Hospital /ID# 221692
Kurashiki-shi Okayama, 710-8, Japan
Kansai Medical University Hospital /ID# 221482
Hirakata-shi Osaka, 573-1, Japan
Kindai University Hospital /ID# 221479
Osakasayama-shi Osaka, 589-8, Japan
Osaka University Hospital /ID# 221478
Suita-shi Osaka, 565-0, Japan
Dokkyo Medical University Saitama Medical Center /ID# 222333
Koshigaya-shi Saitama, 343-8, Japan
Juntendo University Shizuoka Hospital /ID# 221782
Izunokuni-shi Shizuoka, 410-2, Japan
Juntendo University Hospital /ID# 221405
Bunkyo-ku Tokyo, 113-8, Japan
Nippon Medical School Hospital /ID# 221674
Bunkyo-ku Tokyo, 113-8, Japan
University of Yamanashi Hospital /ID# 221701
Chuo-shi Yamanashi, 409-3, Japan
Seoul National University Bundang Hospital /ID# 219053
Seongnam Gyeonggido, 13620, Korea, Republic of
Inje University Busan Paik Hospital /ID# 231667
Busan , 47392, Korea, Republic of
Pusan National University Hospital /ID# 222087
Busan , 49241, Korea, Republic of
Kyungpook National University Hospital /ID# 231666
Daegu , 41944, Korea, Republic of
Gachon University Gil Medical Center /ID# 222089
Incheon , 21565, Korea, Republic of
Seoul National University Hospital /ID# 219055
Seoul , 03080, Korea, Republic of
Asan Medical Center /ID# 219054
Seoul , 05505, Korea, Republic of
Samsung Medical Center /ID# 221068
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056
Seoul , 06591, Korea, Republic of
Radboud Universitair Medisch Centrum /ID# 218948
Nijmegen Gelderland, 6525 , Netherlands
Albert Schweitzer Ziekenhuis /ID# 224015
Dordrecht Zuid-Holland, 3318 , Netherlands
Universitair Medisch Centrum Groningen /ID# 218947
Groningen , 9713 , Netherlands
Universitair Medisch Centrum Utrecht /ID# 218949
Utrecht , 3584 , Netherlands
Middlemore Clinical Trials /ID# 230770
Papatoetoe Auckland, 2025, New Zealand
Moscow State budget healthcare /ID# 221025
Moscow Moskva, 12528, Russian Federation
Clinic UZI 4D /ID# 221024
Pyatigorsk Stavropol Skiy Kray, 35750, Russian Federation
Republican hospital named after V.A. Baranov /ID# 221412
Petrozavodsk , 18501, Russian Federation
Leningrad Regional Clinical Hospital /ID# 221028
Saint Petersburg , 19429, Russian Federation
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029
Sankt-Peterburg , 19102, Russian Federation
Almazov National Medical Research Centre /ID# 221033
Sankt-Peterburg , 19734, Russian Federation
Tula Regional Clinical Hospital /ID# 221027
Tula , 30005, Russian Federation
University Clinical Center Serbia /ID# 230854
Belgrade Beograd, 11000, Serbia
Clin Hosp Ctr Bezanijska Kosa /ID# 230946
Belgrade Beograd, 11080, Serbia
University Clinical Center Kragujevac /ID# 230855
Kragujevac Sumadijski Okrug, 34000, Serbia
Clinical Center Vojvodina /ID# 230853
Novi Sad Vojvodina, 21000, Serbia
Wits Clinical Research Site /ID# 232071
Johannesburg Gauteng, 2193, South Africa
Wits Clinical Research Site /ID# 232072
Johannesburg Gauteng, 2193, South Africa
Albert Alberts Stem Cell Transplant Centre /ID# 232073
Pretoria Gauteng, 0044, South Africa
Hospital Clínico Universitario de Santiago-CHUS /ID# 222264
Santiago de Compostela A Coruna, 15706, Spain
Hospital Universitario Germans Trias i Pujol /ID# 229936
Badalona Barcelona, 08916, Spain
Hospital Universitario Dr. Negrin /ID# 220897
Las Palmas de Gran Canaria Las Palmas, 35019, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720
Pamplona Navarra, 31008, Spain
Hospital Parc de Salut del Mar /ID# 220913
Barcelona , 08003, Spain
Hospital Universitario Vall d'Hebron /ID# 229690
Barcelona , 08035, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721
Madrid , 28027, Spain
Hospital Universitario Ramon y Cajal /ID# 220877
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre /ID# 229691
Madrid , 28041, Spain
Hospital Universitario Virgen de la Victoria /ID# 220878
Malaga , 29010, Spain
Hospital Clinico Universitario de Valencia /ID# 220875
Valencia , 46010, Spain
Orebro Universitetssjukhuset /ID# 220829
Orebro Orebro Lan, 701 8, Sweden
Skane University Hospital Lund /ID# 220835
Lund Skane Lan, SE 22, Sweden
Sahlgrenska University Hospital /ID# 218776
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Kaohsiung Chang Gung Memorial Hospital /ID# 218984
Kaohsiung , 833, Taiwan
China Medical University Hospital /ID# 218978
Taichung City , 40447, Taiwan
Chi Mei Hospital - Liouying /ID# 221145
Tainan City , 73657, Taiwan
National Taiwan University Hospital /ID# 218976
Taipei City , 100, Taiwan
Taipei Veterans General Hosp /ID# 221146
Taipei City , 11217, Taiwan
Linkou Chang Gung Memorial Hospital /ID# 218983
Taoyuan City , 333, Taiwan
Hacettepe University Medical Faculty /ID# 230759
Ankara , 06230, Turkey
Trakya University Medical Facu /ID# 230754
Edirne, Istanbul , 22030, Turkey
Bagcilar Medipol Mega Universite Hastanesi /ID# 230757
Istanbul , 34214, Turkey
Ege University Medical Faculty /ID# 230753
Izmir , 35040, Turkey
Inonu University Medical Faculty /ID# 230758
Malatya , 44280, Turkey
Communal non-profit enterprise Regional Center of Oncology /ID# 230832
Kharkiv , 61070, Ukraine
Medical Center "OK!Clinic+" /ID# 230834
Kyiv , 02091, Ukraine
Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370
Kyiv , 03143, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833
Lviv , 79044, Ukraine
United Lincolnshire Hospitals NHS Trust /ID# 231471
Lincoln Lincolnshire, LN2 4, United Kingdom
Guys and St Thomas NHS Foundation Trust /ID# 219185
London London, City Of, SE1 9, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 219192
Oxford Oxfordshire, OX3 9, United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 221333
Birmingham , B15 2, United Kingdom
The Christie Hospital /ID# 219191
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myeloproliferative Neoplasms

Phase:

Phase 3

Estimated Enrollment:

252

Study ID:

NCT04472598

Recruitment Status:

Active, not recruiting

Sponsor:


AbbVie

How clear is this clinincal trial information?

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