Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet Versus Best Available Therapy to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis

NCT04468984 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M20-1782023-507273-18-00
• Study Type: interventional
• Target: 330
• Locations: 28 countries
• Sites: 221

Brief Summary

Myelofibrosis (MF) is a rare blood cancer, notable for scarring of the bone marrow (the spongy tissue inside bones) and the spleen becoming larger. The purpose of this study is to assess safety and change in spleen volume when navitoclax is given in combination with ruxolitinib, compared to best available therapy, for adult participants with MF. Navitoclax is an investigational drug (not yet approved) being developed for the treatment of MF. Participants in this study will be randomly selected (like picking numbers out of a hat) to be in 1 of 2 treatment arms. Neither participants nor the study doctor will be able to pick which treatment arm a participants enters. In Arm A, participants will receive navitoclax in combination with ruxolitinib. In Arm B, participants will receive the best available therapy (BAT) for MF. In Arm C, participants will receive navitoclax. Adult participants with a diagnosis of MF that came back or did not get better after earlier treatment will be enrolled. Approximately 330 participants will be enrolled in approximately 322 sites across the world. In Arm A, participants will receive navitoclax tablet by mouth once daily with by mouth ruxolitinib tablet twice daily. In Arm B, participants will receive the BAT available to the investigator. In Arm C, participants will receive navitoclax tablet by mouth once daily. Participants will receive the study drug until they experience no benefit (determined by the investigator), participants cannot tolerate the study drugs, or participants withdraw consent. The approximate treatment duration is about 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of treatment will be checked by medical assessments, blood and bone marrow tests, checking for side effects, and completing questionnaires.

Conditions

Myelofibrosis (MF)

Keywords

ABT-263; Navitoclax; Ruxolitinib; MF; Myelofibrosis; Cancer

Outcome Measures

Primary Outcomes (1)

• Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% 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.

  At Week 24

Secondary Outcomes (9)

• Arms A and B: Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS)

  Baseline (Week 0) Up to Week 24

• Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time

  Baseline (Week 0) Up to Week 97

• Arms A and B: Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis

  Baseline (Week 0) Up to Week 97

• Arms A and B: Percentage of Participants with Anemia Response

  Baseline (Week 0) Up to Week 97

• Arms A and B: Percentage of Participants with Overall Survival

  Last Visit Up to 5 Years

Study Arms (3)

Arm A: Navitoclax + Ruxolitinib

EXPERIMENTAL

Participants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.

Drug: Navitoclax; Drug: Ruxolitinib

Arm B: Best Available Therapy (BAT)

ACTIVE COMPARATOR

Participants will receive one of the BAT options, per the investigator's discretion.

Drug: Best Available Therapy (BAT)

Arm C: Continued Access for Navitoclax

EXPERIMENTAL

Participants will receive navitoclax tablets once daily.

Drug: Navitoclax

Interventions

Navitoclax DRUG

Tablet; Oral

Arm A: Navitoclax + Ruxolitinib; Arm C: Continued Access for Navitoclax

Ruxolitinib DRUG

Tablet; Oral

Arm A: Navitoclax + Ruxolitinib

Best Available Therapy (BAT) DRUG

Tablet/Capsule; Oral or Solution for Subcutaneous Injection

Arm B: Best Available Therapy (BAT)

Eligibility Criteria

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

You may qualify if:

• Must complete the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of the 7 days immediately prior to the date of randomization and must agree to collect MFSAF data daily by ePRO device during the study collection window.
• \-- Has at least 2 symptoms each with an average score \>= 3 or an average total score of \>= 12, as measured by the MFSAF v4.0.
• Documented diagnosis of primary myelofibrosis (MF) as defined by the World Health Organization (WHO) classification, post polycythemia vera (PPV)-MF, or post essential thrombocytopenia (PET)-MF, characterized by bone marrow fibrosis grades 2 or 3.
• Classified as intermediate-2 or high-risk MF, as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
• Must currently be on treatment or have received prior treatment with a single Janus Kinase 2 (JAK2) inhibitor, ruxolitinib, and meet one of the following criteria (in addition to the minimum splenomegaly and symptom burden also required for eligibility):
• Treatment with ruxolitinib for \>= 24 weeks that was stopped due to lack of spleen response (refractory), or loss of spleen response or symptom control after a previous response (relapsed), or was continued despite relapsed/refractory status.
• Treatment with ruxolitinib for \< 24 weeks with documented disease progression while on therapy as defined by any of the following:
• Appearance of new splenomegaly that is palpable to at least 5 cm below the left costal margin (LCM) in participants with no evidence of splenomegaly prior to the initiation of ruxolitinib.
• A \>= 100% increase in the palpable distance below the LCM in participants with measurable spleen distance 5 to 10 centimeters (cm) prior to the initiation of ruxolitinib.
• A \>= 50% increase in the palpable distance below the LCM in participants with measurable spleen distance \> 10 cm prior to the initiation of ruxolitinib.
• A spleen volume increase of \>= 25% (as assessed by Magnetic Resonance Imaging \[MRI\] or Computed Tomography \[CT\] scan) in participants with a spleen volume assessment prior to the initiation of ruxolitinib.
• Prior treatment with ruxolitinib of at least 10 mg twice daily (BID) for \>= 28 days with intolerance defined as new RBC transfusion requirement (at least 2 units/month for 2 months) while receiving a total daily ruxolitinib dose of \>= 30 mg but unable to reduce dose further due to lack of efficacy.
• Note: Participant must not require a ruxolitinib dose less than 10 mg BID (20 mg daily) due to prior history of ruxolitinibrelated ≥ Grade 3 toxicity.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Splenomegaly defined as palpable spleen measurement \>= 5 cm below left costal margin or spleen volume \>= 450 cm3 as assessed centrally by MRI or CT scan.

You may not qualify if:

• Received prior treatment with a B-cell lymphoma 2 homology 3 (BH3)-mimetic compound, bromodomain and extra-terminal (BET) inhibitor, phosphoinositide 3- kinase and telomerase inhibitors (e.g., parsaclisib), prior use of \> 1 JAK2 inhibitor or stem cell transplant.
• Eligible for stem cell transplantation at the time of study entry.
• 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 mg daily) and low molecular weight heparin (LMWH).
• Receiving anticancer therapy for an active malignancy or MF including chemotherapy, radiation therapy, hormonal therapy such that at least 5 half-lives of that medication is completed at least 7 days prior to the first dose of study drug or within 30 days prior to first dose of study drug, whichever is shorter, and during the study treatment period (other than any overlapping therapy as part of the selected BAT).

Sponsors & Collaborators

• AbbVie: lead

Study Sites (229)

Ironwood Cancer & Res Ctr /ID# 222162

Chandler, Arizona, 85224-5665, United States

Location

Highlands Oncology Group, PA /ID# 221826

Springdale, Arkansas, 72762, United States

Location

City of Hope /ID# 218996

Duarte, California, 91010, United States

Location

Providence - St. Jude Medical Center /ID# 271382

Fullerton, California, 92835, United States

Location

Moores Cancer Center /ID# 271596

La Jolla, California, 92037, United States

Location

Moores Cancer Center at UC San Diego /ID# 219009

La Jolla, California, 92093, United States

Location

Long Beach Memorial Medical Ct /ID# 224542

Long Beach, California, 90806-1701, United States

Location

Icri /Id# 221967

Whittier, California, 90603, United States

Location

St. Mary's Hospital Regional Cancer Center /ID# 224229

Grand Junction, Colorado, 81501-6132, United States

Location

Augusta University Georgia Cancer Center /ID# 219051

Augusta, Georgia, 30912-0003, United States

Location

Columbus Regional Research Institute /ID# 224410

Columbus, Georgia, 31904-8915, United States

Location

University of Chicago Medical Center /ID# 271373

Chicago, Illinois, 60637, United States

Location

Northwest Oncology & Hematology - Elk Grove Village /ID# 222818

Elk Grove Village, Illinois, 60007-3361, United States

Location

Loyola University Medical Ctr /ID# 219048

Maywood, Illinois, 60153, United States

Location

Indiana Blood & Marrow Transpl /ID# 221587

Indianapolis, Indiana, 46237, United States

Location

Tulane Medical Center - New Orleans /ID# 222940

New Orleans, Louisiana, 70112-2600, United States

Location

Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777

New Orleans, Louisiana, 70121, United States

Location

American Oncology Partners of Maryland /ID# 222836

Bethesda, Maryland, 20817, United States

Location

Dana-Farber Cancer Institute /ID# 218998

Boston, Massachusetts, 02215, United States

Location

University of Michigan /ID# 218463

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital /ID# 221190

Detroit, Michigan, 48202, United States

Location

William Beaumont Hospital /ID# 222705

Royal Oak, Michigan, 48073-6710, United States

Location

Saint Louis University Cancer Center /ID# 222287

St Louis, Missouri, 63110-2539, United States

Location

Summit Medical Group-Florham Park /ID# 222620

Florham Park, New Jersey, 07932-1049, United States

Location

Hackensack Univ Med Ctr /ID# 219047

Hackensack, New Jersey, 07601, United States

Location

The Cancer Institute at St. Francis Hospital /ID# 231782

Greenvale, New York, 11548-1219, United States

Location

Manhattan Hematology Oncology MHO Associates /ID# 223193

New York, New York, 10016-6028, United States

Location

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 221081

New York, New York, 10065-6007, United States

Location

Atrium Health Wake Forest Baptist Medical Center /ID# 222899

Winston-Salem, North Carolina, 27157-0001, United States

Location

MetroHealth Medical Center /ID# 222650

Cleveland, Ohio, 44109, United States

Location

Pennsylvania Cancer Specialists & Research Institute /ID# 271376

Gettysburg, Pennsylvania, 17325, United States

Location

Hospital of the University of Pennsylvania /ID# 219001

Philadelphia, Pennsylvania, 19104-4238, United States

Location

Fox Chase Cancer Center /ID# 223955

Philadelphia, Pennsylvania, 19111, United States

Location

Texas Oncology - Abilene - Antilley Road /ID# 271379

Abilene, Texas, 79606, United States

Location

Duplicate_Houston Methodist Hospital /ID# 223103

Houston, Texas, 77030, United States

Location

University of Texas Health San Antonio MD Anderson Cancer Center /ID# 233942

San Antonio, Texas, 78229, United States

Location

Utah Cancer Specialists Salt Lake Clinic /ID# 221962

Salt Lake City, Utah, 84106, United States

Location

Virginia Cancer Specialists - Fairfax /ID# 223016

Fairfax, Virginia, 22031, United States

Location

Providence Everett /ID# 223130

Everett, Washington, 98201, United States

Location

Yakima Valley Memorial Hosp /ID# 224368

Yakima, Washington, 98902-6388, United States

Location

HSHS St. Vincent Hospital /ID# 224468

Green Bay, Wisconsin, 54301, United States

Location

The Kinghorn Cancer Centre /ID# 221097

Darlinghurst, New South Wales, 2010, Australia

Location

Border Medical Oncology Research Unit Albury Wodonga Regiona /ID# 223848

East Albury, New South Wales, 2640, Australia

Location

Calvary Mater Newcastle /ID# 224324

Waratah, New South Wales, 2298, Australia

Location

The Alfred Hospital /ID# 221096

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital /ID# 221099

Perth, Western Australia, 6000, Australia

Location

Universitaetsklinikum St. Poelten /ID# 221709

Sankt Pölten, Lower Austria, 3100, Austria

Location

Medizinische Universitaet Graz /ID# 220919

Graz, Styria, 8010, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen /ID# 220914

Linz, Upper Austria, 4010, Austria

Location

Klinikum Wels-Grieskirchen GmbH /ID# 220915

Wels, Upper Austria, 4600, Austria

Location

Medizinische Universitaet Wien /ID# 220911

Vienna, Vienna, 1090, Austria

Location

Hanusch Krankenhaus /ID# 220912

Vienna, 1140, Austria

Location

ZAS Cadix /ID# 221468

Antwerp, Antwerpen, 2030, Belgium

Location

Cliniques Universitaires UCL Saint-Luc /ID# 224221

Brussels, Brussels Capital, 1200, Belgium

Location

Grand Hôpital de Charleroi - Les Viviers /ID# 224827

Charleroi, Hainaut, 6280, Belgium

Location

UZ Gent /ID# 220841

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Vitaz /Id# 228150

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

AZ-Delta /ID# 221469

Roeselare, West-Vlaanderen, 8800, Belgium

Location

UMHAT Alexandrovska EAD /ID# 231652

Sofiya, Sofia, 1431, Bulgaria

Location

UMHAT Dr Georgi Stranski EAD /ID# 231650

Pleven, 5800, Bulgaria

Location

Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649

Sofia, 1407, Bulgaria

Location

UMHAT Sveti Ivan Rilski /ID# 231651

Sofia, 1431, Bulgaria

Location

UMHAT Sveta Marina /ID# 234119

Varna, 9010, Bulgaria

Location

Juravinski Cancer Centre /ID# 220887

Hamilton, Ontario, L8V 1C3, Canada

Location

Ottawa Hospital Research Institute /ID# 238858

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network_Princess Margaret Cancer Centre /ID# 253942

Toronto, Ontario, M5G 2M9, Canada

Location

CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 222433

Lévis, Quebec, G6V 3Z1, Canada

Location

McGill University Health Centre - Glen Site /ID# 222614

Montreal, Quebec, H4A 3J1, Canada

Location

CHUQ- Hôpital de l'Enfant-Jesus /ID# 220888

Québec, Quebec, G1J 1Z4, Canada

Location

Clinical Hospital Dubrava /ID# 230801

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicka bolnica Merkur /ID# 230799

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Zagreb /ID# 230798

Zagreb, City of Zagreb, 10000, Croatia

Location

Klinicki bolnicki centar Osijek /ID# 231503

Osijek, County of Osijek-Baranja, 31000, Croatia

Location

Klinicki Bolnicki Centar (KBC) Split /ID# 230800

Split, Split-Dalmatia County, 21000, Croatia

Location

Fakultní Nemocnice Brno - Jihlavská /ID# 220959

Brno, Brno-mesto, 625 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze /ID# 220969

Prague, 128 08, Czechia

Location

Aalborg University Hospital /ID# 224391

Aalborg, North Denmark, 9000, Denmark

Location

Roskilde Sygehus /ID# 224456

Roskilde, Region Sjælland, 4000, Denmark

Location

Duplicate_CHU DE NICE-HOPITAL LARCHET II /ID# 256291

Nice, Alpes-Maritimes, 06200, France

Location

CHU NIMES - Hopital Caremeau /ID# 219128

Nîmes, Gard, 30029, France

Location

Centre Hospitalier Universitaire de Bordeaux /ID# 222696

Pessac, Gironde, 33604, France

Location

CHU de Nantes, Hotel Dieu -HME /ID# 219127

Nantes, Pays de la Loire Region, 44000, France

Location

HCL - Hopital Lyon Sud /ID# 222695

Pierre-Bénite, Rhone, 69495, France

Location

Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 223771

Chambéry, Savoie, 73007, France

Location

Chu Angers /Id# 219129

Angers, 49933, France

Location

Hôpital Saint-Louis /ID# 221390

Paris, 75010, France

Location

Hopital Avicenne - APHP /ID# 221287

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

Location

Universitatsklinikum Mannheim /ID# 221529

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Stauferklinikum Schwaebisch Gmuend /ID# 223948

Mutlangen, Baden-Wurttemberg, 73557, Germany

Location

Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 225025

Augsburg, Bavaria, 86150, Germany

Location

Universitaetsmedizin Rostock /ID# 224157

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

Augusta-Kranken-Anstalt gGmbH, Bochum-Mitte /ID# 224695

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Klinikum Chemnitz gGmbH /ID# 224575

Chemnitz, Saxony, 09116, Germany

Location

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221346

Dresden, Saxony, 01307, Germany

Location

OncoResearch Lerchenfeld GmbH /ID# 225034

Hamburg, 22081, Germany

Location

Klinikum rechts der Isar /ID# 221526

Munich, 81675, Germany

Location

Olympion General Clinic /ID# 261423

Pátrai, Achaia, 25443, Greece

Location

General Hospital of Athens Laiko /ID# 221175

Athens, Attica, 11527, Greece

Location

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 221179

Athens, 10676, Greece

Location

University General Hospital of Patras /ID# 221178

RION Patras Achaia, 26504, Greece

Location

General Hospital of Thessaloniki George Papanikolaou /ID# 221463

Thessaloniki, 57010, Greece

Location

Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949

Székesfehérvár, Fejér, 8000, Hungary

Location

Debreceni Egyetem-Klinikai Kozpont /ID# 220947

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948

Kaposvár, Somogy County, 7400, Hungary

Location

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946

Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

Location

Szegedi Tudományegyetem /ID# 220955

Szeged, 6720, Hungary

Location

Yitzhak Shamir Medical Center /ID# 222972

Ẕerifin, Central District, 70300, Israel

Location

HaEmek Medical Center /ID# 220839

Afula, H_efa, 1834111, Israel

Location

Rambam Health Care Campus /ID# 219121

Haifa, H_efa, 3109601, Israel

Location

The Lady Davis Carmel Medical Center /ID# 222973

Haifa, H_efa, 34362, Israel

Location

Hadassah Medical Center-Hebrew University /ID# 219111

Jerusalem, Jerusalem, 91120, Israel

Location

Hadassah Mt. Scopus /ID# 253394

Jerusalem, Jerusalem, 9765400, Israel

Location

Galilee Medical Center /ID# 225280

Nahariya, Northern District, 2210001, Israel

Location

Duplicate_Assuta Ashdod Medical Center /ID# 225281

Ashdod, Southern District, 7747629, Israel

Location

The Chaim Sheba Medical Center /ID# 219136

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center /ID# 219135

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Rabin Medical Center /ID# 219139

Petah Tikva, 4941492, Israel

Location

Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 221077

Bologna, Emilia-Romagna, 40138, Italy

Location

Azienda Ospedaliero Universitaria Careggi /ID# 219090

Florence, Firenze, 50134, Italy

Location

Duplicate_Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita /ID# 219087

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 225113

Monza, Monza E Brianza, 20052, Italy

Location

Azienda Ospedaliera Universitaria Federico II /ID# 224673

Naples, Napoli, 80131, Italy

Location

A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 221223

Turin, Piedmont, 10126, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731

Rome, Roma, 00161, Italy

Location

Azienda Ospedaliero Universitaria delle Marche /ID# 238438

Ancona, 60020, Italy

Location

ASST Papa Giovanni XXIII /ID# 221222

Bergamo, 24127, Italy

Location

AOU Policlinico G. Rodolico - San Marco /ID# 219089

Catania, 95123, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 221078

Palermo, 90127, Italy

Location

Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 221220

Reggio Calabria, 89125, Italy

Location

Duplicate_University Hospital Santa Maria della Misericordia /ID# 221241

Udine, 33100, Italy

Location

ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 234183

Varese, 21100, Italy

Location

Azienda ULSS 8 Berica /ID# 221079

Vicenza, 36100, Italy

Location

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 221150

Nagoya, Aichi-ken, 453-8511, Japan

Location

Fujita Health University Hospital /ID# 221598

Toyoake, Aichi-ken, 470-1192, Japan

Location

Aomori Prefectural Central Hospital /ID# 221778

Aomori, Aomori, 030-8553, Japan

Location

Chiba University Hospital /ID# 224546

Chiba, Chiba, 260-8677, Japan

Location

National Cancer Center Hospital East /ID# 226653

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Ehime University Hospital /ID# 221158

Toon-shi, Ehime, 791-0295, Japan

Location

Kyushu University Hospital /ID# 221606

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukushima Medical University Hospital /ID# 221877

Fukushima, Fukushima, 960-1295, Japan

Location

Gifu University Hospital /ID# 224371

Gifu, Gifu, 501-1194, Japan

Location

Sapporo Hokuyu Hospital /ID# 221149

Sapporo, Hokkaido, 003-0006, Japan

Location

Kobe City Medical Center General Hospital /ID# 221156

Kobe, Hyōgo, 650-0047, Japan

Location

Kanazawa University Hospital /ID# 223028

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Iwate Medical University Hospital /ID# 222044

Shiwa-gun, Iwate, 028-3695, Japan

Location

Shonan Kamakura General Hospital /ID# 223030

Kamakura-shi, Kanagawa, 247-8533, Japan

Location

Kumamoto Shinto General Hospital /ID# 255645

Kumamoto, Kumamoto, 862-8655, Japan

Location

Kyoto University Hospital /ID# 223008

Kyoto, Kyoto, 606-8507, Japan

Location

Mie University Hospital /ID# 221665

Tsu, Mie-ken, 514-8507, Japan

Location

University of Miyazaki Hospital /ID# 221821

Miyazaki, Miyazaki, 889-1692, Japan

Location

Niigata University Medical & Dental Hospital /ID# 223034

Niigata, Niigata, 951-8520, Japan

Location

Kurashiki Central Hospital /ID# 221690

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

Location

Kansai Medical University Hospital /ID# 257289

Hirakata-shi, Osaka, 573-1191, Japan

Location

The University of Osaka Hospital /ID# 221159

Suita-shi, Osaka, 565-0871, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 222334

Koshigaya, Saitama, 343-0845, Japan

Location

Juntendo University Shizuoka Hospital /ID# 221780

Izunokuni-shi, Shizuoka, 410-2295, Japan

Location

Juntendo University Hospital /ID# 221154

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital /ID# 221676

Bunkyo-ku, Tokyo, 113-8602, Japan

Location

Tokyo Medical University Hospital /ID# 221540

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Tokyo Metropolitan Bokutoh Hospital /ID# 254774

Sumida-ku, Tokyo, 130-8575, Japan

Location

University of Yamanashi Hospital /ID# 221706

Chuo-shi, Yamanashi, 409-3821, Japan

Location

IMSUT Hospital, The Institute of Medical Science, The University of Tokyo /ID# 257944

Tokyo, 108-8639, Japan

Location

Aotearoa Clinical Trials /ID# 232201

Papatoetoe, Auckland, 2025, New Zealand

Location

ARS-MEDICAL Sp. z o.o. /ID# 238336

Piła, Greater Poland Voivodeship, 64-920, Poland

Location

Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola /ID# 241031

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221124

Lublin, Lublin Voivodeship, 20-081, Poland

Location

Lux Med Onkologia - Szpital Szamocka /Id# 221265

Warsaw, Masovian Voivodeship, 01-748, Poland

Location

MTZ Clinical Research Powered by Pratia /ID# 221759

Warsaw, Masovian Voivodeship, 02-172, Poland

Location

Uniwersyteckie Centrum Kliniczne /ID# 221298

Gdansk, Pomeranian Voivodeship, 80-214, Poland

Location

Pratia Onkologia Katowice /ID# 224526

Katowice, 40-519, Poland

Location

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 221161

Lodz, Łódź Voivodeship, 93-513, Poland

Location

Hospital del Centro Comprensivo de Cancer de la UPR /ID# 223281

San Juan, 00927, Puerto Rico

Location

Moscow State budget healthcare /ID# 221116

Moscow, Moscow, 125284, Russia

Location

Clinic UZI 4D /ID# 221303

Pyatigorsk, Stavropol Kray, 357502, Russia

Location

Hospital n.a. V.V. Veresaev /ID# 225221

Moscow, 127644, Russia

Location

Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221115

Saint Petersburg, 191024, Russia

Location

Almazov National Medical Research Centre /ID# 221114

Saint Petersburg, 197341, Russia

Location

Tula Regional Clinical Hospital /ID# 221302

Tula, 300053, Russia

Location

University Clinical Center Serbia /ID# 231058

Belgrade, Beograd, 11000, Serbia

Location

Clin Hosp Ctr Bezanijska Kosa /ID# 231059

Belgrade, Beograd, 11080, Serbia

Location

University Clinical Center Vojvodina /ID# 231057

Novi Sad, 21000, Serbia

Location

Duplicate_Wits Clinical Research Site /ID# 231554

Johannesburg, Gauteng, 2193, South Africa

Location

Alberts Cellular Therapy /ID# 231556

Pretoria, Gauteng, 0044, South Africa

Location

Pusan National University Hospital /ID# 220980

Busan, Busan Gwang Yeogsi, 49241, South Korea

Location

Gachon University Gil Medical Center /ID# 220972

Incheon, Gyeonggido, 21565, South Korea

Location

Seoul National University Hospital /ID# 219060

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Samsung Medical Center /ID# 221091

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

The Catholic University of Korea, Seoul St. Marys Hospital /ID# 219061

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Complejo Hospitalario Universitario A Coruña /ID# 224617

A Coruña, A Coruna, 15006, Spain

Location

Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 221616

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitario Germans Trias i Pujol /ID# 233727

Badalona, Barcelona, 08916, Spain

Location

Hospital Universitario Dr. Negrin /ID# 220923

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

Location

Hospital Universitario Central de Asturias /ID# 224815

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital Parc de Salut del Mar /ID# 220922

Barcelona, 08003, Spain

Location

Hospital Universitario Vall d'Hebron /ID# 240979

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 253936

Granada, 18014, Spain

Location

Hospital Universitario 12 de Octubre /ID# 233726

Madrid, 28041, Spain

Location

Hospital Universitario La Paz /ID# 224813

Madrid, 28046, Spain

Location

Hospital Regional Universitario de Malaga /ID# 221906

Málaga, 29011, Spain

Location

Hospital Universitario de Salamanca /ID# 221904

Salamanca, 37711, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 221932

Seville, 41013, Spain

Location

Hospital Clinico Universitario de Valencia /ID# 220920

Valencia, 46010, Spain

Location

Skane University Hospital Lund /ID# 220834

Lund, Skåne County, 224 84, Sweden

Location

Duplicate_Universitätsspital Basel /ID# 221261

Basel, Canton of Basel-City, 4031, Switzerland

Location

Inselspital, Universitaetsspital Bern /ID# 223439

Bern, 3010, Switzerland

Location

Kaohsiung Chang Gung Memorial Hospital /ID# 218985

Kaohsiung City, Kaohsiung, 833, Taiwan

Location

Chi Mei Hospital - Liouying /ID# 221144

Tainan, Tainan, 73657, Taiwan

Location

National Taiwan University Hospital /ID# 271207

Taipei City, Taipei, 100, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 218980

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 271389

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital /ID# 218979

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital /ID# 271206

Tainan, 704, Taiwan

Location

Taipei Veterans General Hosp /ID# 221147

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital /ID# 218982

Taoyuan, 333, Taiwan

Location

Medipol Mega Üniversite Hastanesi /ID# 271374

Tuzla, Istanbul, 34953, Turkey (Türkiye)

Location

Gulhane Askeri Tip Academy /ID# 224568

Ankara, 06010, Turkey (Türkiye)

Location

Hacettepe Universitesi Hastaneleri /ID# 271084

Ankara, 06230, Turkey (Türkiye)

Location

Trakya University Medical Facu /ID# 224572

Edirne, Istanbul, 22030, Turkey (Türkiye)

Location

Ege University Medical Faculty /ID# 224570

Izmir, 35040, Turkey (Türkiye)

Location

Mersin University Medical /ID# 224571

Mersin, 33343, Turkey (Türkiye)

Location

Ondokuz mayis University Facul /ID# 224567

Samsun, 55200, Turkey (Türkiye)

Location

Feofaniya Clinical Hospital of State Management of Affairs /ID# 271397

Kyiv, 03143, Ukraine

Location

Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 221041

London, Greater London, SE1 9RT, United Kingdom

Location

United Lincolnshire Hospitals NHS Trust /ID# 224613

Lincoln, Lincolnshire, LN2 4AX, United Kingdom

Location

James Paget University Hospitals NHS Foundation Trust /ID# 221219

Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust /ID# 221334

Birmingham, B15 2TH, United Kingdom

Location

NHS Lothian /ID# 224378

Edinburgh, EH3 9HE, United Kingdom

Location

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 221335

Newcastle upon Tyne, NE3 3HD, United Kingdom

Location

MeSH Terms

Conditions

Primary Myelofibrosis; Neoplasms

Interventions

navitoclax; ruxolitinib

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 13, 2020
• Study Start: August 31, 2020
• Primary Completion: January 29, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

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

DE (9); TW (9); GB (6); FR (9); ES (14); DK (2); IT (15); UA (1); HU (5); SE (1); NZ (1); CR (5); CZ (2); RU (6); BE (6); PR (1); CA (6); AU (6); CH (2); KR (5); TU (7); GR (5); BU (5); US (41); JP (30); IL (11); ZA (2); PL (9)