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

NCT04472598 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: M16-1912020-000097-15
• Study Type: interventional
• Target: 252
• Locations: 23 countries
• Sites: 185

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.

Conditions

Myelofibrosis (MF)

Keywords

Myelofibrosis; Navitoclax; Ruxolitinib; Cancer; ABT-263; TRANSFORM-1

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume at Week 24 (SVR35W24)

  Reduction in spleen volume is measured by magnetic resonance imaging (MRI) or computed tomography (CT), per International Working Group (IWG) criteria.

  Baseline, Week 24

Secondary Outcomes (9)

• Change From Baseline in Total Symptom Score (TSS) at Week 24 as Measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0

  Baseline, Week 24

• Percentage of Participants With ≥ 35% Reduction From Baseline in Spleen Volume (SVR35) at Any Time

  Up to Week 97

• Duration of 35% Spleen Volume Reduction (SVR35)

  Baseline (Week 0) Up to Month 48

• Change From Baseline In Fatigue at Week 24 as Measured by the PROMIS Fatigue Short Form (SF) 7a

  Baseline, Week 24

• Change From Baseline at Week 24 in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

  Baseline, Week 24

Study Arms (2)

Placebo for Navitoclax + Ruxolitinib

ACTIVE COMPARATOR

Placebo for navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (\>150 × 10\^9/L starting dose of 200 mg; ≤150 × 10\^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10\^9/L). Placebo for navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 25, Day 1 visit, placebo for navitoclax dose may be increased to 300 mg QD at Investigator's discretion for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Ruxolitinib tablets were administered orally twice daily (BID) per Baseline platelet count (\>200 × 10\^9/L starting dose of 20 mg; 100-200 × 10\^9/L starting dose of 15 mg). Participants will continue their treatment until end of clinical benefit, unacceptable toxicity, or they meet other protocol criteria for discontinuation (whichever occurs first).

Drug: Placebo for Navitoclax; Drug: Ruxolitinib

Navitoclax + Ruxolitinib

EXPERIMENTAL

Navitoclax tablets were administered orally once daily (QD) per Baseline platelet count (\>150 × 10\^9/L starting dose of 200 mg; ≤150 × 10\^9/L starting dose of 100 mg, which could be increased to 200 mg QD after 7 days provided platelet count is ≥75 × 10\^9/L). Navitoclax didn't exceed 200 mg QD for first 24 weeks of treatment. After Week 25, Day 1 visit, navitoclax dose may be increased to 300 mg QD at Investigator's discretion for those with suboptimal spleen response defined as failure to achieve spleen volume reduction of at least 10% per imaging. Ruxolitinib tablets were administered orally twice daily (BID) per Baseline platelet count (\>200 × 10\^9/L starting dose of 20 mg; 100-200 × 10\^9/L starting dose of 15 mg). Participants will continue their treatment until end of clinical benefit, unacceptable toxicity, or they meet other protocol criteria for discontinuation (whichever occurs first).

Drug: Ruxolitinib; Drug: Navitoclax

Interventions

Navitoclax DRUG

Film-coated tablet; Oral

Also known as: ABT-263

Navitoclax + Ruxolitinib

Ruxolitinib DRUG

Tablet; Oral

Also known as: Jakafi

Navitoclax + Ruxolitinib; Placebo for Navitoclax + Ruxolitinib

Placebo for Navitoclax DRUG

Film-coated tablet; Oral

Placebo for Navitoclax + Ruxolitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Thrombocythemia \[PET\] - 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (194)

Highlands Oncology Group, PA /ID# 221824

Springdale, Arkansas, 72762, United States

Location

Providence - St. Jude Medical Center /ID# 241646

Fullerton, California, 92835, United States

Location

Moores Cancer Center at UC San Diego /ID# 218012

La Jolla, California, 92093, United States

Location

Rocky Mountain Cancer Centers - Littleton /ID# 222562

Littleton, Colorado, 80120, United States

Location

Lynn Cancer Institute, Boca /ID# 230687

Boca Raton, Florida, 33486, United States

Location

Florida Cancer Specialist - South /ID# 221726

Fort Myers, Florida, 33901-8108, United States

Location

Florida Cancer Specialists - North /ID# 221727

St. Petersburg, Florida, 33705-1449, United States

Location

Florida Cancer Specialists - East /ID# 221728

West Palm Beach, Florida, 33401, United States

Location

Duplicate_Emory University /ID# 221562

Atlanta, Georgia, 30322-1013, United States

Location

Augusta University Georgia Cancer Center /ID# 221551

Augusta, Georgia, 30912-0003, United States

Location

Columbus Regional Research Institute /ID# 227272

Columbus, Georgia, 31904-8915, United States

Location

Duplicate_Rush University Medical Center /ID# 221581

Chicago, Illinois, 60612, United States

Location

Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204

Normal, Illinois, 61761, United States

Location

Indiana Blood & Marrow Transpl /ID# 221586

Indianapolis, Indiana, 46237, United States

Location

University of Kansas Cancer Center /ID# 218144

Fairway, Kansas, 66205-2528, United States

Location

Massachusetts General Hospital /ID# 221559

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center /ID# 224261

Boston, Massachusetts, 02215-5400, United States

Location

Dana-Farber Cancer Institute /ID# 218010

Boston, Massachusetts, 02215, United States

Location

University of Michigan /ID# 221658

Ann Arbor, Michigan, 48109-5000, United States

Location

Minnesota Oncology Hematology /ID# 227357

Edina, Minnesota, 55435, United States

Location

MidAmerica Division, Inc. /ID# 221743

Kansas City, Missouri, 64132, United States

Location

Hackensack Univ Med Ctr /ID# 221654

Hackensack, New Jersey, 07601, United States

Location

Northwell Health - Monter Cancer Center /ID# 222996

Lake Success, New York, 11042, United States

Location

Weill Cornell Medical College /ID# 220933

New York, New York, 10065, United States

Location

Gabrail Cancer Center Research /ID# 230488

Canton, Ohio, 44718, United States

Location

Oncology Hematology Care, Inc. /ID# 222556

Cincinnati, Ohio, 45236-2725, United States

Location

The Ohio State University /ID# 221584

Columbus, Ohio, 43210, United States

Location

UPMC Hillman Cancer Ctr /ID# 218134

Pittsburgh, Pennsylvania, 15232, United States

Location

Thompson Cancer Survival Ctr /ID# 231689

Knoxville, Tennessee, 37916, United States

Location

University of Texas MD Anderson Cancer Center /ID# 217994

Houston, Texas, 77030, United States

Location

Texas Oncology - Northeast Texas /ID# 241813

Tyler, Texas, 75702, United States

Location

Utah Cancer Specialists Salt Lake Clinic /ID# 221961

Salt Lake City, Utah, 84106, United States

Location

University of Utah /ID# 221009

Salt Lake City, Utah, 84112-5500, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 242682

Fairfax, Virginia, 22031, United States

Location

VA Puget Sound Health Care System /ID# 231691

Seattle, Washington, 98108-1597, United States

Location

The Kinghorn Cancer Centre /ID# 221503

Darlinghurst, New South Wales, 2010, Australia

Location

Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 231311

East Albury, New South Wales, 2640, Australia

Location

Gosford Hospital /ID# 221499

Gosford, New South Wales, 2250, Australia

Location

Liverpool Hospital /ID# 221803

Liverpool, New South Wales, 2170, Australia

Location

Townsville University Hospital /ID# 229794

Douglas, Queensland, 4814, Australia

Location

Peter MacCallum Cancer Ctr /ID# 229795

Melbourne, Victoria, 3000, Australia

Location

The Alfred Hospital /ID# 221501

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital /ID# 223203

Perth, Western Australia, 6000, Australia

Location

Duplicate_Medizinische Universitaet Graz /ID# 220910

Graz, Styria, 8010, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 220813

Linz, Upper Austria, 4010, Austria

Location

Klinikum Wels-Grieskirchen GmbH /ID# 220901

Wels, Upper Austria, 4600, Austria

Location

Medizinische Universitaet Wien /ID# 220906

Vienna, Vienna, 1090, Austria

Location

Hanusch Krankenhaus /ID# 220909

Vienna, 1140, Austria

Location

ZAS Cadix /ID# 221465

Antwerp, Antwerpen, 2030, Belgium

Location

CHU de Liège /ID# 218874

Liège, Liege, 4000, Belgium

Location

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 221127

Yvoir, Namur, 5530, Belgium

Location

UZ Gent /ID# 221125

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Vitaz /Id# 229861

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

Universitair Ziekenhuis Leuven /ID# 218806

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ-Delta /ID# 221466

Roeselare, West-Vlaanderen, 8800, Belgium

Location

AZ Sint-Jan Brugge /ID# 218805

Bruges, 8000, Belgium

Location

UMHAT Alexandrovska EAD /ID# 231056

Sofiya, Sofia, 1431, Bulgaria

Location

UMHAT Dr Georgi Stranski EAD /ID# 231161

Pleven, 5800, Bulgaria

Location

UMHAT Sveti Georgi /ID# 231053

Plovdiv, 4002, Bulgaria

Location

Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036

Sofia, 1407, Bulgaria

Location

UMHAT Sveti Ivan Rilski /ID# 231028

Sofia, 1431, Bulgaria

Location

Royal Victoria Hospital /ID# 222636

Barrie, Ontario, L4M 6M2, Canada

Location

Juravinski Cancer Centre /ID# 221752

Hamilton, Ontario, L8V 1C3, Canada

Location

Lakeridge Health - Oshawa /ID# 222080

Oshawa, Ontario, L1G 2B9, Canada

Location

Niagara Health System /ID# 230994

St. Catharines, Ontario, L2S 0A9, Canada

Location

CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754

Québec, Quebec, G1J 1Z4, Canada

Location

Clinical Hospital Dubrava /ID# 230795

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicka bolnica Merkur /ID# 231155

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 230793

Zagreb, City of Zagreb, 10000, Croatia

Location

Duplicate_Klinicki bolnicki centar Split /ID# 230796

Split, Split-Dalmatia County, 21000, Croatia

Location

CHU NIMES - Hopital Caremeau /ID# 219114

Nîmes, Gard, 30029, France

Location

Centre Hospitalier Universitaire de Bordeaux /ID# 222518

Pessac, Gironde, 33604, France

Location

CH Roubaix - Hopital Victor Provo /ID# 219116

Roubaix, Hauts-de-France, 59100, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 219113

Nantes, Pays de la Loire Region, 44000, France

Location

HCL - Hopital Lyon Sud /ID# 222913

Pierre-Bénite, Rhone, 69495, France

Location

Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 224506

Chambéry, Savoie, 73007, France

Location

Chu Angers /Id# 219115

Angers, 49933, France

Location

Hôpital Saint-Louis /ID# 221288

Paris, 75010, France

Location

AP-HP - Hopital Necker /ID# 231318

Paris, 75015, France

Location

ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978

Strasbourg, 67033, France

Location

Hopital Avicenne - APHP /ID# 221286

Bobigny, Île-de-France Region, 93000, France

Location

Universitatsklinikum Mannheim /ID# 221523

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Haemato-Onkologie /ID# 221061

Munich, Bavaria, 81241, Germany

Location

Universitaetsklinikum Aachen /ID# 221519

Aachen, North Rhine-Westphalia, 52074, Germany

Location

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347

Dresden, Saxony, 01307, Germany

Location

Universitaetsklinikum Essen /ID# 221522

Essen, 45147, Germany

Location

OncoResearch Lerchenfeld GmbH /ID# 230867

Hamburg, 22081, Germany

Location

Klinikum rechts der Isar /ID# 221520

Munich, 81675, Germany

Location

General Hospital of Athens Laiko /ID# 230785

Athens, Attica, 11527, Greece

Location

Duplicate_University General Hospital Attikon /ID# 230784

Athens, Attica, 12462, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786

Athens, 10676, Greece

Location

Meir Medical Center /ID# 221374

Kfar Saba, Central District, 4428164, Israel

Location

Yitzhak Shamir Medical Center /ID# 222957

Ẕerifin, Central District, 70300, Israel

Location

Rambam Health Care Campus /ID# 219120

Haifa, H_efa, 3109601, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 219110

Jerusalem, Jerusalem, 91120, Israel

Location

The Chaim Sheba Medical Center /ID# 219137

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 219134

Tel Aviv, Tel Aviv, 6423906, Israel

Location

IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 220867

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Careggi /ID# 219086

Florence, Firenze, 50134, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083

Rome, Roma, 00168, Italy

Location

ASST Papa Giovanni XXIII /ID# 221907

Bergamo, 24127, Italy

Location

ASST degli Spedali Civili di Brescia /ID# 241273

Brescia, 25123, Italy

Location

AOU Policlinico G. Rodolico - San Marco /ID# 219085

Catania, 95123, Italy

Location

Duplicate_ASST Sette Laghi /ID# 219084

Varese, 21100, Italy

Location

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100

Nagoya, Aichi-ken, 453-8511, Japan

Location

Fujita Health University Hospital /ID# 221537

Toyoake, Aichi-ken, 470-1192, Japan

Location

Duplicate_Chiba University Hospital /ID# 239345

Chiba, Chiba, 260-8677, Japan

Location

National Cancer Center Hospital East /ID# 226093

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Ehime University Hospital /ID# 221443

Toon-shi, Ehime, 791-0295, Japan

Location

Kyushu University Hospital /ID# 221783

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital /ID# 222752

Fukushima, Fukushima, 960-1295, Japan

Location

Ogaki Municipal Hospital /ID# 240173

Ogaki-shi, Gifu, 503-8502, Japan

Location

Gunmaken Saiseikai Maebashi Hospital /ID# 242806

Maebashi, Gunma, 371-0821, Japan

Location

Gunma University Hospital /ID# 221480

Maebashi, Gunma, 371-8511, Japan

Location

Duplicate_Hokkaido University Hospital /ID# 242667

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital /ID# 246236

Kobe, Hyōgo, 650-0017, Japan

Location

Hitachi General Hospital /ID# 240048

Hitachi-shi, Ibaraki, 317-0077, Japan

Location

Kanazawa University Hospital /ID# 238424

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Medical Corporation Seijinkai Ikeda Hospital /ID# 242172

Kanoya-shi, Kagoshima-ken, 893-0024, Japan

Location

Kyoto University Hospital /ID# 238423

Kyoto, Kyoto, 606-8507, Japan

Location

Mie University Hospital /ID# 221664

Tsu, Mie-ken, 514-8507, Japan

Location

University of Miyazaki Hospital /ID# 221483

Miyazaki, Miyazaki, 889-1692, Japan

Location

Duplicate_Kawasaki Medical School Hospital /ID# 221481

Kurashiki-shi, Okayama-ken, 701-0192, Japan

Location

Kurashiki Central Hospital /ID# 221692

Kurashiki-shi, Okayama-ken, 710-8602, Japan

Location

Kansai Medical University Hospital /ID# 221482

Hirakata-shi, Osaka, 573-1191, Japan

Location

Kindai University Hospital /ID# 221479

Osakasayama-shi, Osaka, 589-8511, Japan

Location

The University of Osaka Hospital /ID# 221478

Suita-shi, Osaka, 565-0871, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 222333

Koshigaya, Saitama, 343-0845, Japan

Location

Juntendo University Shizuoka Hospital /ID# 221782

Izunokuni-shi, Shizuoka, 410-2295, Japan

Location

Juntendo University Hospital /ID# 221405

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital /ID# 221674

Bunkyo-ku, Tokyo, 113-8602, Japan

Location

University of Yamanashi Hospital /ID# 221701

Chuo-shi, Yamanashi, 409-3821, Japan

Location

Radboud Universitair Medisch Centrum /ID# 218948

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Albert Schweitzer Ziekenhuis /ID# 224015

Dordrecht, South Holland, 3318 AT, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 218947

Groningen, 9713 GZ, Netherlands

Location

Universitair Medisch Centrum Utrecht /ID# 218949

Utrecht, 3584 CX, Netherlands

Location

Aotearoa Clinical Trials /ID# 230770

Papatoetoe, Auckland, 2025, New Zealand

Location

Moscow State budget healthcare /ID# 221025

Moscow, Moscow, 125284, Russia

Location

Republican hospital named after V.A. Baranov /ID# 221412

Petrozavodsk, Murmansk Oblast, 185019, Russia

Location

Clinic UZI 4D /ID# 221024

Pyatigorsk, Stavropol Kray, 357502, Russia

Location

Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029

Saint Petersburg, 191024, Russia

Location

Leningrad Regional Clinical Hospital /ID# 221028

Saint Petersburg, 194291, Russia

Location

Almazov National Medical Research Centre /ID# 221033

Saint Petersburg, 197341, Russia

Location

Tula Regional Clinical Hospital /ID# 221027

Tula, 300053, Russia

Location

University Clinical Center Serbia /ID# 230854

Belgrade, Beograd, 11000, Serbia

Location

Clin Hosp Ctr Bezanijska Kosa /ID# 230946

Belgrade, Beograd, 11080, Serbia

Location

University Clinical Center Kragujevac /ID# 230855

Kragujevac, Sumadijski Okrug, 34000, Serbia

Location

Duplicate_Clinical Center Vojvodina /ID# 230853

Novi Sad, Vojvodina, 21000, Serbia

Location

Wits Clinical Research /ID# 232072

Johannesburg, Gauteng, 1864, South Africa

Location

Duplicate_Wits Clinical Research Site /ID# 232071

Johannesburg, Gauteng, 2193, South Africa

Location

Alberts Cellular Therapy /ID# 232073

Pretoria, Gauteng, 0044, South Africa

Location

Duplicate_Inje University Busan Paik Hospital /ID# 231667

Busan, Busan Gwang Yeogsi, 47392, South Korea

Location

Pusan National University Hospital /ID# 222087

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Duplicate_Kyungpook National University Hospital /ID# 231666

Daegu, Daegu Gwang Yeogsi, 41944, South Korea

Location

Gachon University Gil Medical Center /ID# 222089

Incheon, Gyeonggido, 21565, South Korea

Location

Duplicate_Seoul National University Bundang Hospital /ID# 219053

Seongnam, Gyeonggido, 13620, South Korea

Location

Seoul National University Hospital /ID# 219055

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Asan Medical Center /ID# 219054

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center /ID# 221068

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219056

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 222264

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitario Germans Trias i Pujol /ID# 229936

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Dr. Negrin /ID# 220897

Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

Location

Clinica Universidad de Navarra - Pamplona /ID# 230720

Pamplona, Navarre, 31008, Spain

Location

Hospital Parc de Salut del Mar /ID# 220913

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 229690

Barcelona, 08035, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721

Madrid, 28027, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 220877

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre /ID# 229691

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 220878

Málaga, 29010, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 220875

Valencia, 46010, Spain

Location

Duplicate_Skane University Hospital Lund /ID# 220835

Lund, Skåne County, 221 41, Sweden

Location

Duplicate_Sahlgrenska University Hospital /ID# 218776

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Orebro Universitetssjukhuset /ID# 220829

Örebro, Örebro County, 701 85, Sweden

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 218984

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

Chi Mei Hospital - Liouying /ID# 221145

Tainan, Tainan, 73657, Taiwan

Location

National Taiwan University Hospital /ID# 218976

Taipei City, Taipei, 100, Taiwan

Location

China Medical University Hospital /ID# 218978

Taichung, 40447, Taiwan

Location

Taipei Veterans General Hosp /ID# 221146

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 218983

Taoyuan, 333, Taiwan

Location

Hacettepe University Medical Faculty /ID# 230759

Ankara, 06230, Turkey (Türkiye)

Location

Trakya University Medical Facu /ID# 230754

Edirne, Istanbul, 22030, Turkey (Türkiye)

Location

Bagcilar Medipol Mega Universite Hastanesi /ID# 230757

Istanbul, 34214, Turkey (Türkiye)

Location

Ege University Medical Faculty /ID# 230753

Izmir, 35040, Turkey (Türkiye)

Location

Inonu University Medical Faculty /ID# 230758

Malatya, 44280, Turkey (Türkiye)

Location

Communal non-profit enterprise Regional Center of Oncology /ID# 230832

Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine

Location

Medical Center OK Clinic LLC, International Institute of Clinical Research /ID# 230834

Kyiv, 02091, Ukraine

Location

Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370

Kyiv, 03143, Ukraine

Location

SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833

Lviv, 79044, Ukraine

Location

Guys and St Thomas NHS Foundation Trust /ID# 219185

London, Greater London, SE1 9RT, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust /ID# 231471

Lincoln, Lincolnshire, LN2 4AX, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust /ID# 219192

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 221333

Birmingham, B15 2TH, United Kingdom

Location

The Christie Hospital /ID# 219191

Manchester, M20 4BX, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Primary Myelofibrosis; Neoplasms

Interventions

navitoclax; ruxolitinib

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 15, 2020
• Study Start: September 29, 2020
• Primary Completion: April 13, 2023
• Study Completion: January 29, 2025
• Last Updated: March 23, 2026
• Results First Posted: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

RU (7); ES (11); TW (6); JP (28); UA (4); SE (3); KR (9); ZA (3); FR (11); AU (8); CR (4); GB (5); BU (5); TU (5); BE (8); US (35); GR (3); IT (7); NZ (1); DE (7); CA (5); NL (4); IL (6)