AzTrials
AzTrials

Myelofibrosis (MF)Phase 3TRANSFORM-2NCT04468984

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

A Phase 3 study testing Navitoclax, Ruxolitinib and Best Available Therapy (BAT) in people with Myelofibrosis (MF), run by AbbVie at 229 sites in 30 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelofibrosis (MF)
What is being tested?
Navitoclax, Ruxolitinib and Best Available Therapy (BAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
229 sitesin 30 countries
Study dates
31 Aug 2020to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Baseline platelet count >= 100 × 10^9/L.

Who cannot join

  • 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).

Trial locations and contacts

229 sites in 30 countries.

229 sites in 30 countries

United States41 sites

  • Texas Oncology - Abilene - Antilley Road /ID# 271379

    Abilene, Texas, 79606

  • University of Michigan /ID# 218463

    Ann Arbor, Michigan, 48109

  • Augusta University Georgia Cancer Center /ID# 219051

    Augusta, Georgia, 30912-0003

  • American Oncology Partners of Maryland /ID# 222836

    Bethesda, Maryland, 20817

  • Dana-Farber Cancer Institute /ID# 218998

    Boston, Massachusetts, 02215

  • Ironwood Cancer & Res Ctr /ID# 222162

    Chandler, Arizona, 85224-5665

  • University of Chicago Medical Center /ID# 271373

    Chicago, Illinois, 60637

  • MetroHealth Medical Center /ID# 222650

    Cleveland, Ohio, 44109

  • Columbus Regional Research Institute /ID# 224410

    Columbus, Georgia, 31904-8915

  • Henry Ford Hospital /ID# 221190

    Detroit, Michigan, 48202

  • City of Hope /ID# 218996

    Duarte, California, 91010

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

    Elk Grove Village, Illinois, 60007-3361

  • Providence Everett /ID# 223130

    Everett, Washington, 98201

  • Virginia Cancer Specialists - Fairfax /ID# 223016

    Fairfax, Virginia, 22031

  • Summit Medical Group-Florham Park /ID# 222620

    Florham Park, New Jersey, 07932-1049

  • Providence - St. Jude Medical Center /ID# 271382

    Fullerton, California, 92835

  • Pennsylvania Cancer Specialists & Research Institute /ID# 271376

    Gettysburg, Pennsylvania, 17325

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

    Grand Junction, Colorado, 81501-6132

  • HSHS St. Vincent Hospital /ID# 224468

    Green Bay, Wisconsin, 54301

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

    Greenvale, New York, 11548-1219

  • Hackensack Univ Med Ctr /ID# 219047

    Hackensack, New Jersey, 07601

  • Duplicate_Houston Methodist Hospital /ID# 223103

    Houston, Texas, 77030

  • Indiana Blood & Marrow Transpl /ID# 221587

    Indianapolis, Indiana, 46237

  • Moores Cancer Center /ID# 271596

    La Jolla, California, 92037

  • Moores Cancer Center at UC San Diego /ID# 219009

    La Jolla, California, 92093

  • Long Beach Memorial Medical Ct /ID# 224542

    Long Beach, California, 90806-1701

  • Loyola University Medical Ctr /ID# 219048

    Maywood, Illinois, 60153

  • Tulane Medical Center - New Orleans /ID# 222940

    New Orleans, Louisiana, 70112-2600

  • Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 222777

    New Orleans, Louisiana, 70121

  • Manhattan Hematology Oncology MHO Associates /ID# 223193

    New York, New York, 10016-6028

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

    New York, New York, 10065-6007

  • Hospital of the University of Pennsylvania /ID# 219001

    Philadelphia, Pennsylvania, 19104-4238

  • Fox Chase Cancer Center /ID# 223955

    Philadelphia, Pennsylvania, 19111

  • William Beaumont Hospital /ID# 222705

    Royal Oak, Michigan, 48073-6710

  • Utah Cancer Specialists Salt Lake Clinic /ID# 221962

    Salt Lake City, Utah, 84106

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

    San Antonio, Texas, 78229

  • Highlands Oncology Group, PA /ID# 221826

    Springdale, Arkansas, 72762

  • Saint Louis University Cancer Center /ID# 222287

    St Louis, Missouri, 63110-2539

  • Icri /Id# 221967

    Whittier, California, 90603

  • Atrium Health Wake Forest Baptist Medical Center /ID# 222899

    Winston-Salem, North Carolina, 27157-0001

  • Yakima Valley Memorial Hosp /ID# 224368

    Yakima, Washington, 98902-6388

Other trials in United States

Japan30 sites

  • Aomori Prefectural Central Hospital /ID# 221778

    Aomori, Aomori, 030-8553

  • Juntendo University Hospital /ID# 221154

    Bunkyo-ku, Tokyo, 113-8431

  • Nippon Medical School Hospital /ID# 221676

    Bunkyo-ku, Tokyo, 113-8602

  • Chiba University Hospital /ID# 224546

    Chiba, Chiba, 260-8677

  • University of Yamanashi Hospital /ID# 221706

    Chuo-shi, Yamanashi, 409-3821

  • Kyushu University Hospital /ID# 221606

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital /ID# 221877

    Fukushima, Fukushima, 960-1295

  • Gifu University Hospital /ID# 224371

    Gifu, Gifu, 501-1194

  • Kansai Medical University Hospital /ID# 257289

    Hirakata-shi, Osaka, 573-1191

  • Juntendo University Shizuoka Hospital /ID# 221780

    Izunokuni-shi, Shizuoka, 410-2295

  • Shonan Kamakura General Hospital /ID# 223030

    Kamakura-shi, Kanagawa, 247-8533

  • Kanazawa University Hospital /ID# 223028

    Kanazawa, Ishikawa-ken, 920-8641

  • National Cancer Center Hospital East /ID# 226653

    Kashiwa-shi, Chiba, 277-8577

  • Kobe City Medical Center General Hospital /ID# 221156

    Kobe, Hyōgo, 650-0047

  • Dokkyo Medical University Saitama Medical Center /ID# 222334

    Koshigaya, Saitama, 343-0845

  • Kumamoto Shinto General Hospital /ID# 255645

    Kumamoto, Kumamoto, 862-8655

  • Kurashiki Central Hospital /ID# 221690

    Kurashiki-shi, Okayama-ken, 710-8602

  • Kyoto University Hospital /ID# 223008

    Kyoto, Kyoto, 606-8507

  • University of Miyazaki Hospital /ID# 221821

    Miyazaki, Miyazaki, 889-1692

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

    Nagoya, Aichi-ken, 453-8511

  • Niigata University Medical & Dental Hospital /ID# 223034

    Niigata, Niigata, 951-8520

  • Sapporo Hokuyu Hospital /ID# 221149

    Sapporo, Hokkaido, 003-0006

  • Tokyo Medical University Hospital /ID# 221540

    Shinjuku-ku, Tokyo, 160-0023

  • Iwate Medical University Hospital /ID# 222044

    Shiwa-gun, Iwate, 028-3695

  • The University of Osaka Hospital /ID# 221159

    Suita-shi, Osaka, 565-0871

  • Tokyo Metropolitan Bokutoh Hospital /ID# 254774

    Sumida-ku, Tokyo, 130-8575

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

    Tokyo, 108-8639

  • Ehime University Hospital /ID# 221158

    Toon-shi, Ehime, 791-0295

  • Fujita Health University Hospital /ID# 221598

    Toyoake, Aichi-ken, 470-1192

  • Mie University Hospital /ID# 221665

    Tsu, Mie-ken, 514-8507

Other trials in Japan

Italy15 sites

  • Azienda Ospedaliero Universitaria delle Marche /ID# 238438

    Ancona, 60020

  • ASST Papa Giovanni XXIII /ID# 221222

    Bergamo, 24127

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

    Bologna, Emilia-Romagna, 40138

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

    Catania, 95123

  • Azienda Ospedaliero Universitaria Careggi /ID# 219090

    Florence, Firenze, 50134

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

    Monza, Monza E Brianza, 20052

  • Azienda Ospedaliera Universitaria Federico II /ID# 224673

    Naples, Napoli, 80131

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 221078

    Palermo, 90127

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

    Reggio Calabria, 89125

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

    Rome, Lazio, 00168

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 225731

    Rome, Roma, 00161

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

    Turin, Piedmont, 10126

  • Duplicate_University Hospital Santa Maria della Misericordia /ID# 221241

    Udine, 33100

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

    Varese, 21100

  • Azienda ULSS 8 Berica /ID# 221079

    Vicenza, 36100

Other trials in Italy

Spain14 sites

  • Complejo Hospitalario Universitario A Coruña /ID# 224617

    A Coruña, A Coruna, 15006

  • Hospital Universitario Germans Trias i Pujol /ID# 233727

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 220922

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron /ID# 240979

    Barcelona, 08035

  • Hospital Universitario Virgen de las Nieves /ID# 253936

    Granada, 18014

  • Hospital Universitario Dr. Negrin /ID# 220923

    Las Palmas de Gran Canaria, Las Palmas, 35019

  • Hospital Universitario 12 de Octubre /ID# 233726

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 224813

    Madrid, 28046

  • Hospital Regional Universitario de Malaga /ID# 221906

    Málaga, 29011

  • Hospital Universitario Central de Asturias /ID# 224815

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario de Salamanca /ID# 221904

    Salamanca, 37711

  • Duplicate_Hospital Clínico Universitario de Santiago-CHUS /ID# 221616

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen del Rocio /ID# 221932

    Seville, 41013

  • Hospital Clinico Universitario de Valencia /ID# 220920

    Valencia, 46010

Other trials in Spain

Israel11 sites

  • HaEmek Medical Center /ID# 220839

    Afula, H_efa, 1834111

  • Duplicate_Assuta Ashdod Medical Center /ID# 225281

    Ashdod, Southern District, 7747629

  • Rambam Health Care Campus /ID# 219121

    Haifa, H_efa, 3109601

  • The Lady Davis Carmel Medical Center /ID# 222973

    Haifa, H_efa, 34362

  • Hadassah Medical Center-Hebrew University /ID# 219111

    Jerusalem, Jerusalem, 91120

  • Hadassah Mt. Scopus /ID# 253394

    Jerusalem, Jerusalem, 9765400

  • Galilee Medical Center /ID# 225280

    Nahariya, Northern District, 2210001

  • Rabin Medical Center /ID# 219139

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center /ID# 219136

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 219135

    Tel Aviv, Tel Aviv, 6423906

  • Yitzhak Shamir Medical Center /ID# 222972

    Tsrifin, Central District, 70300

Other trials in Israel

France9 sites

  • Chu Angers /Id# 219129

    Angers, 49933

  • Hopital Avicenne - APHP /ID# 221287

    Bobigny, Île-de-France Region, 93000

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

    Chambéry, Savoie, 73007

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

    Nantes, Pays de la Loire Region, 44000

  • Duplicate_CHU DE NICE-HOPITAL LARCHET II /ID# 256291

    Nice, Alpes-Maritimes, 06200

  • CHU NIMES - Hopital Caremeau /ID# 219128

    Nîmes, Gard, 30029

  • Hôpital Saint-Louis /ID# 221390

    Paris, 75010

  • Centre Hospitalier Universitaire de Bordeaux /ID# 222696

    Pessac, Gironde, 33604

  • HCL - Hopital Lyon Sud /ID# 222695

    Pierre-Bénite, Rhone, 69495

Other trials in France

Germany9 sites

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

    Augsburg, Bavaria, 86150

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

    Bochum, North Rhine-Westphalia, 44791

  • Klinikum Chemnitz gGmbH /ID# 224575

    Chemnitz, Saxony, 09116

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

    Dresden, Saxony, 01307

  • OncoResearch Lerchenfeld GmbH /ID# 225034

    Hamburg, 22081

  • Universitatsklinikum Mannheim /ID# 221529

    Mannheim, Baden-Wurttemberg, 68167

  • Klinikum rechts der Isar /ID# 221526

    Munich, 81675

  • Stauferklinikum Schwaebisch Gmuend /ID# 223948

    Mutlangen, Baden-Wurttemberg, 73557

  • Universitaetsmedizin Rostock /ID# 224157

    Rostock, Mecklenburg-Vorpommern, 18057

Other trials in Germany

Poland9 sites

  • Uniwersyteckie Centrum Kliniczne /ID# 221298

    Gdansk, Pomeranian Voivodeship, 80-214

  • Pratia Onkologia Katowice /ID# 224526

    Katowice, 40-519

  • SP ZOZ Szpital Uniwersytecki w Krakowie /ID# 221160

    Krakow, Lesser Poland Voivodeship, 31-501

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

    Lodz, Łódź Voivodeship, 93-513

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 221124

    Lublin, Lublin Voivodeship, 20-081

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

    Piła, Greater Poland Voivodeship, 64-920

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

    Poznan, Greater Poland Voivodeship, 60-569

  • Lux Med Onkologia - Szpital Szamocka /Id# 221265

    Warsaw, Masovian Voivodeship, 01-748

  • MTZ Clinical Research Powered by Pratia /ID# 221759

    Warsaw, Masovian Voivodeship, 02-172

Other trials in Poland

Taiwan9 sites

  • Kaohsiung Chang Gung Memorial Hospital /ID# 218985

    Kaohsiung City, Kaohsiung, 833

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

    Kaohsiung City, 807

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

    Kaohsiung City, 807

  • China Medical University Hospital /ID# 218979

    Taichung, 40447

  • Chi Mei Hospital - Liouying /ID# 221144

    Tainan, Tainan, 73657

  • National Cheng Kung University Hospital /ID# 271206

    Tainan, 704

  • Taipei Veterans General Hosp /ID# 221147

    Taipei, 11217

  • National Taiwan University Hospital /ID# 271207

    Taipei City, Taipei, 100

  • Linkou Chang Gung Memorial Hospital /ID# 218982

    Taoyuan City, 333

Other trials in Taiwan

Turkey (Türkiye)7 sites

  • Gulhane Askeri Tip Academy /ID# 224568

    Ankara, 06010

  • Hacettepe Universitesi Hastaneleri /ID# 271084

    Ankara, 06230

  • Trakya University Medical Facu /ID# 224572

    Edirne, Istanbul, 22030

  • Ege University Medical Faculty /ID# 224570

    Izmir, 35040

  • Mersin University Medical /ID# 224571

    Mersin, 33343

  • Ondokuz mayis University Facul /ID# 224567

    Samsun, 55200

  • Medipol Mega Üniversite Hastanesi /ID# 271374

    Tuzla, Istanbul, 34953

Other trials in Turkey (Türkiye)

Austria6 sites

  • Medizinische Universitaet Graz /ID# 220919

    Graz, Styria, 8010

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 220914

    Linz, Upper Austria, 4010

  • Universitaetsklinikum St. Poelten /ID# 221709

    Sankt Pölten, Lower Austria, 3100

  • Medizinische Universitaet Wien /ID# 220911

    Vienna, State of Vienna, 1090

  • Hanusch Krankenhaus /ID# 220912

    Vienna, 1140

  • Klinikum Wels-Grieskirchen GmbH /ID# 220915

    Wels, Upper Austria, 4600

Other trials in Austria

Belgium6 sites

  • ZAS Cadix /ID# 221468

    Antwerp, Antwerpen, 2030

  • Cliniques Universitaires UCL Saint-Luc /ID# 224221

    Brussels, Brussels Capital, 1200

  • Grand Hôpital de Charleroi - Les Viviers /ID# 224827

    Charleroi, Hainaut, 6280

  • UZ Gent /ID# 220841

    Ghent, Oost-Vlaanderen, 9000

  • AZ-Delta /ID# 221469

    Roeselare, West-Vlaanderen, 8800

  • Vitaz /Id# 228150

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Canada6 sites

  • Juravinski Cancer Centre /ID# 220887

    Hamilton, Ontario, L8V 1C3

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

    Lévis, Quebec, G6V 3Z1

  • McGill University Health Centre - Glen Site /ID# 222614

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute /ID# 238858

    Ottawa, Ontario, K1H 8L6

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

    Québec, Quebec, G1J 1Z4

  • University Health Network_Princess Margaret Cancer Centre /ID# 253942

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Russia6 sites

  • Moscow State budget healthcare /ID# 221116

    Moscow, Moscow, 125284

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

    Moscow, 127644

  • Clinic UZI 4D /ID# 221303

    Pyatigorsk, Stavropol Kray, 357502

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

    Saint Petersburg, 191024

  • Almazov National Medical Research Centre /ID# 221114

    Saint Petersburg, 197341

  • Tula Regional Clinical Hospital /ID# 221302

    Tula, 300053

Other trials in Russia

United Kingdom6 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 221334

    Birmingham, B15 2TH

  • NHS Lothian /ID# 224378

    Edinburgh, EH3 9HE

  • James Paget University Hospitals NHS Foundation Trust /ID# 221219

    Great Yarmouth, Norfolk, NR31 6LA

  • United Lincolnshire Hospitals NHS Trust /ID# 224613

    Lincoln, Lincolnshire, LN2 4AX

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

    London, Greater London, SE1 9RT

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

    Newcastle upon Tyne, NE3 3HD

Other trials in United Kingdom

Australia5 sites

  • The Kinghorn Cancer Centre /ID# 221097

    Darlinghurst, New South Wales, 2010

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

    East Albury, New South Wales, 2640

  • The Alfred Hospital /ID# 221096

    Melbourne, Victoria, 3004

  • Royal Perth Hospital /ID# 221099

    Perth, Western Australia, 6000

  • Calvary Mater Newcastle /ID# 224324

    Waratah, New South Wales, 2298

Other trials in Australia

Bulgaria5 sites

  • UMHAT Dr Georgi Stranski EAD /ID# 231650

    Pleven, 5800

  • Acibadem City Clinic Tokuda University Hospital EAD /ID# 231649

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 231651

    Sofia, 1431

  • UMHAT Alexandrovska EAD /ID# 231652

    Sofiya, Sofia, 1431

  • UMHAT Sveta Marina /ID# 234119

    Varna, 9010

Other trials in Bulgaria

Croatia5 sites

  • Klinicki bolnicki centar Osijek /ID# 231503

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki Bolnicki Centar (KBC) Split /ID# 230800

    Split, Split-Dalmatia County, 21000

  • Clinical Hospital Dubrava /ID# 230801

    Zagreb, City of Zagreb, 10000

  • Klinicka bolnica Merkur /ID# 230799

    Zagreb, City of Zagreb, 10000

  • Klinicki bolnicki centar Zagreb /ID# 230798

    Zagreb, City of Zagreb, 10000

Other trials in Croatia

Greece5 sites

  • General Hospital of Athens Laiko /ID# 221175

    Athens, Attica, 11527

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

    Athens, 10676

  • Olympion General Clinic /ID# 261423

    Pátrai, Achaia, 25443

  • University General Hospital of Patras /ID# 221178

    RION Patras Achaia, 26504

  • General Hospital of Thessaloniki George Papanikolaou /ID# 221463

    Thessaloniki, 57010

Other trials in Greece

Hungary5 sites

  • Debreceni Egyetem-Klinikai Kozpont /ID# 220947

    Debrecen, Hajdú-Bihar, 4032

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 220948

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 220946

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Szegedi Tudományegyetem /ID# 220955

    Szeged, 6720

  • Fejér Vármegyei Szent György Egyetemi Oktató Kórház /ID# 220949

    Székesfehérvár, Fejér, 8000

Other trials in Hungary

South Korea5 sites

  • Pusan National University Hospital /ID# 220980

    Busan, Busan Gwang Yeogsi, 49241

  • Gachon University Gil Medical Center /ID# 220972

    Incheon, Gyeonggido, 21565

  • Seoul National University Hospital /ID# 219060

    Seoul, Seoul Teugbyeolsi, 03080

  • Samsung Medical Center /ID# 221091

    Seoul, Seoul Teugbyeolsi, 06351

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

    Seoul, Seoul Teugbyeolsi, 06591

Other trials in South Korea

Serbia3 sites

  • University Clinical Center Serbia /ID# 231058

    Belgrade, Beograd, 11000

  • Clin Hosp Ctr Bezanijska Kosa /ID# 231059

    Belgrade, Beograd, 11080

  • University Clinical Center Vojvodina /ID# 231057

    Novi Sad, 21000

Other trials in Serbia

Czechia2 sites

  • Fakultní Nemocnice Brno - Jihlavská /ID# 220959

    Brno, Brno-mesto, 625 00

  • Vseobecna fakultni nemocnice v Praze /ID# 220969

    Prague, 128 08

Other trials in Czechia

Denmark2 sites

  • Aalborg University Hospital /ID# 224391

    Aalborg, North Denmark, 9000

  • Roskilde Sygehus /ID# 224456

    Roskilde, Region Sjælland, 4000

Other trials in Denmark

South Africa2 sites

  • Duplicate_Wits Clinical Research Site /ID# 231554

    Johannesburg, Gauteng, 2193

  • Alberts Cellular Therapy /ID# 231556

    Pretoria, Gauteng, 0044

Other trials in South Africa

Switzerland2 sites

  • Duplicate_Universitätsspital Basel /ID# 221261

    Basel, Canton of Basel-City, 4031

  • Inselspital, Universitaetsspital Bern /ID# 223439

    Bern, 3010

Other trials in Switzerland

New Zealand1 site

  • Aotearoa Clinical Trials /ID# 232201

    Papatoetoe, Auckland, 2025

Other trials in New Zealand

Puerto Rico1 site

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

    San Juan, 00927

Other trials in Puerto Rico

Sweden1 site

  • Skane University Hospital Lund /ID# 220834

    Lund, Skåne County, 224 84

Other trials in Sweden

Ukraine1 site

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

    Kyiv, 03143

Other trials in Ukraine

About this study

Official title: Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2), Incorporating Extension Arm C - Continued Access for Navitoclax to Roll Over Subjects From Studies M10-166, M16-109, M16-191, and M19-753

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.

Read more

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.

Being tested
Navitoclax, Ruxolitinib, Best Available Therapy (BAT)
Keywords
ABT-263, Navitoclax, Ruxolitinib, MF, Myelofibrosis, Cancer
Medical subject headings
Primary Myelofibrosis, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NavitoclaxDrug

    Tablet; Oral

  • RuxolitinibDrug

    Tablet; Oral

  • Best Available Therapy (BAT)Drug

    Tablet/Capsule; Oral or Solution for Subcutaneous Injection

Study groups in NCT04468984
Study groupRoleWhat they receive
Arm A: Navitoclax + RuxolitinibExperimentalParticipants will receive navitoclax tablets once daily and ruxolitinib tablets twice daily.
Receives: Drug: Navitoclax; Drug: Ruxolitinib
Arm B: Best Available Therapy (BAT)Active comparatorParticipants will receive one of the BAT options, per the investigator's discretion.
Receives: Drug: Best Available Therapy (BAT)
Arm C: Continued Access for NavitoclaxExperimentalParticipants will receive navitoclax tablets once daily.
Receives: Drug: Navitoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At Week 24

Secondary outcomes (9)

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

    Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.

    Measured: Baseline (Week 0) Up to Week 24

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

    Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.

    Measured: Baseline (Week 0) Up to Week 97

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

    Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.

    Measured: Baseline (Week 0) Up to Week 97

  4. Arms A and B: Percentage of Participants with Anemia Response

    Anemia response per International Working Group (IWG) criteria will be assessed.

    Measured: Baseline (Week 0) Up to Week 97

  5. Arms A and B: Percentage of Participants with Overall Survival

    Overall survival is defined as the time from start of study to the date of death from any cause.

    Measured: Last Visit Up to 5 Years

  6. Arms A and B: Percentage of Participants with Leukemia-free Survival

    Leukemia free survival is the time from start of study to the date of development of leukemia.

    Measured: Last Visit Up to 5 Years

  7. Arms A and B: Percentage of Participants with Change in Fatigue

    Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.

    Measured: Baseline (Week 0) Up to Week 24

  8. Arms A and B: Time to Deterioration of Physical Functioning

    Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.

    Measured: Baseline (Week 0) Up to Week 97

  9. Arms A and B: Percentage of Participants with at Least 50% Reduction in TSS

    At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.

    Measured: Baseline (Week 0) Up to Week 97

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start31 Aug 2020
  3. Primary completion29 Jan 2025
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04468984
Sponsor's protocol ID
M20-178
Other IDs
2023-507273-18-00, 2023
Acronym
TRANSFORM-2
Status last verified
Jan 2026
First submitted
10 Jul 2020
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Publications

  • Rampal RK, Harrison CN, Mesa R, Vannucchi AM, Shimoda K, Perkins A, Garcia JS, Reiter A, Radinoff A, Pane F, Palandri F, Lomaia E, Lee SE, Chuah HS, Passamonti F, Saydam G, Turgut M, Yoon SS, Bain EE, Lam H, Jain S, Potluri J, Kiladjian JJ. Navitoclax monotherapy or in combination with ruxolitinib in patients with JAK2 inhibitor-treated myelofibrosis: results from the phase 2 REFINE and phase 3 TRANSFORM-2 studies. Leuk Lymphoma. 2026 Oct 7:1-11. doi: 10.1080/10428194.2026.2739358. Online ahead of print.

    PubMed 42842696

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Navitoclax, Ruxolitinib and Best Available Therapy (BAT) in people with Myelofibrosis (MF), run by AbbVie at 229 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Japan, Italy, Spain, Israel and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arms A and B: Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) (time frame: At Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04468984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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