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.
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 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 Janus Kinase-2 (JAK-2) inhibitor.
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).
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There are 186 Locations for this study
Springdale Arkansas, 72762, United States
Fullerton California, 92835, United States
La Jolla California, 92093, United States
Littleton Colorado, 80120, United States
Boca Raton Florida, 33486, United States
Fort Myers Florida, 33901, United States
Saint Petersburg Florida, 33705, United States
West Palm Beach Florida, 33401, United States
Atlanta Georgia, 30322, United States
Augusta Georgia, 30912, United States
Columbus Georgia, 31904, United States
Chicago Illinois, 60612, United States
Normal Illinois, 61761, United States
Indianapolis Indiana, 46237, United States
Fairway Kansas, 66205, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 48109, United States
Edina Minnesota, 55435, United States
Kansas City Missouri, 64132, United States
Hackensack New Jersey, 07601, United States
Lake Success New York, 11042, United States
New York New York, 10065, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45236, United States
Columbus Ohio, 43210, United States
Pittsburgh Pennsylvania, 15232, United States
Knoxville Tennessee, 37916, United States
Houston Texas, 77030, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Fairfax Virginia, 22031, United States
Seattle Washington, 98108, United States
Darlinghurst New South Wales, 2010, Australia
East Albury New South Wales, 2640, Australia
Gosford New South Wales, 2250, Australia
Liverpool New South Wales, 2170, Australia
Douglas Queensland, 4814, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Perth Western Australia, 6000, Australia
Linz Oberoesterreich, 4010, Austria
Wels Oberoesterreich, 4600, Austria
Graz Steiermark, 8010, Austria
Vienna Wien, 1090, Austria
Wien , 1140, Austria
Godinne Namur, 5530, Belgium
Gent Oost-Vlaanderen, 9000, Belgium
Leuven Vlaams-Brabant, 3000, Belgium
Roeselare West-Vlaanderen, 8800, Belgium
Antwerp , 2060, Belgium
Brugge , 8000, Belgium
Liege , 4000, Belgium
Sint-Niklaas , 9100, Belgium
Sofiya Sofia, 1431, Bulgaria
Pleven , 5800, Bulgaria
Plovdiv , 4002, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8V 1, Canada
Oshawa Ontario, L1G 2, Canada
St Catharines Ontario, L2S 0, Canada
Quebec City Quebec, G1J 1, Canada
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Zagreb Grad Zagreb, 10000, Croatia
Split Splitsko-dalmatinska Zupanija, 21000, Croatia
Pierre Benite CEDEX Auvergne-Rhone-Alpes, 69495, France
Nimes CEDEX 9 Gard, 30029, France
Pessac Gironde, 33604, France
Roubaix Cedex 1 Hauts-de-France, 59100, France
Bobigny Ile-de-France, 93000, France
Nantes Pays-de-la-Loire, 44000, France
Chambery Savoie, 73000, France
Angers , 49933, France
Paris , 75010, France
Paris , 75015, France
Strasbourg Cedex , 67033, France
Mannheim Baden-Wuerttemberg, 68167, Germany
Muenchen Bayern, 81241, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Dresden Sachsen, 01307, Germany
Essen , 45147, Germany
Hamburg , 22081, Germany
Munich , 81675, Germany
Athens Attiki, 11527, Greece
Athens Attiki, 12462, Greece
Athens , 10676, Greece
Ramat Gan Tel-Aviv, 52656, Israel
Tel Aviv-Yafo Tel-Aviv, 64239, Israel
Jerusalem Yerushalayim, 91120, Israel
Be'Er Ya'Akov , 70300, Israel
Haifa , 31096, Israel
Kfar Saba , 44281, Israel
Rome Lazio, 00168, Italy
Bergamo , 24127, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Catania , 95123, Italy
Florence , 50134, Italy
Varese , 21100, Italy
Nagoya-shi Aichi, 453-8, Japan
Toyoake-shi Aichi, 470-1, Japan
Chiba-shi Chiba, 260-8, Japan
Kashiwa-shi Chiba, 277-8, Japan
Toon-shi Ehime, 791-0, Japan
Fukuoka-shi Fukuoka, 812-8, Japan
Fukushima-shi Fukushima, 960-1, Japan
Ogaki-shi Gifu, 503-8, Japan
Maebashi-shi Gunma, 371-0, Japan
Maebashi-shi Gunma, 371-8, Japan
Sapporo-shi Hokkaido, 060-8, Japan
Kobe-shi Hyogo, 650-0, Japan
Hitachi-shi Ibaraki, 317-0, Japan
Kanazawa-shi Ishikawa, 920-8, Japan
Kanoya-shi Kagoshima, 893-0, Japan
Kyoto-shi Kyoto, 606-8, Japan
Tsu-shi Mie, 514-8, Japan
Miyazaki-shi Miyazaki, 889-1, Japan
Kurashiki-shi Okayama, 701-0, Japan
Kurashiki-shi Okayama, 710-8, Japan
Hirakata-shi Osaka, 573-1, Japan
Osakasayama-shi Osaka, 589-8, Japan
Suita-shi Osaka, 565-0, Japan
Koshigaya-shi Saitama, 343-8, Japan
Izunokuni-shi Shizuoka, 410-2, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Chuo-shi Yamanashi, 409-3, Japan
Seongnam Gyeonggido, 13620, Korea, Republic of
Busan , 47392, Korea, Republic of
Busan , 49241, Korea, Republic of
Daegu , 41944, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Nijmegen Gelderland, 6525 , Netherlands
Dordrecht Zuid-Holland, 3318 , Netherlands
Groningen , 9713 , Netherlands
Utrecht , 3584 , Netherlands
Papatoetoe Auckland, 2025, New Zealand
Moscow Moskva, 12528, Russian Federation
Pyatigorsk Stavropol Skiy Kray, 35750, Russian Federation
Petrozavodsk , 18501, Russian Federation
Saint Petersburg , 19429, Russian Federation
Sankt-Peterburg , 19102, Russian Federation
Sankt-Peterburg , 19734, Russian Federation
Tula , 30005, Russian Federation
Belgrade Beograd, 11000, Serbia
Belgrade Beograd, 11080, Serbia
Kragujevac Sumadijski Okrug, 34000, Serbia
Novi Sad Vojvodina, 21000, Serbia
Johannesburg Gauteng, 2193, South Africa
Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0044, South Africa
Santiago de Compostela A Coruna, 15706, Spain
Badalona Barcelona, 08916, Spain
Las Palmas de Gran Canaria Las Palmas, 35019, Spain
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Valencia , 46010, Spain
Orebro Orebro Lan, 701 8, Sweden
Lund Skane Lan, SE 22, Sweden
Gothenburg Vastra Gotalands Lan, 413 4, Sweden
Kaohsiung City Kaohsiung, 833, Taiwan
Taichung City , 40447, Taiwan
Tainan City , 73657, Taiwan
Taipei City , 100, Taiwan
Taipei City , 11217, Taiwan
Taoyuan City , 333, Taiwan
Ankara , 06230, Turkey
Edirne, Istanbul , 22030, Turkey
Istanbul , 34214, Turkey
Izmir , 35040, Turkey
Malatya , 44280, Turkey
Kharkiv , 61070, Ukraine
Kyiv , 02091, Ukraine
Kyiv , 03143, Ukraine
Lviv , 79044, Ukraine
Lincoln Lincolnshire, LN2 4, United Kingdom
London London, City Of, SE1 9, United Kingdom
Oxford Oxfordshire, OX3 9, United Kingdom
Birmingham , B15 2, United Kingdom
Manchester , M20 4, United Kingdom
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