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New hope for myelofibrosis patients: drug combo shows promise in shrinking spleens

NCT ID NCT03222609

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called navitoclax, either alone or added to the standard drug ruxolitinib, in 191 people with myelofibrosis. The main goal was to see if the treatment could shrink the spleen by at least 35% after 24 weeks. The trial also looked at whether it could reduce symptoms like fatigue and night sweats. Participants had intermediate-2 or high-risk disease and were not eligible for a stem cell transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Navitoclax and ruxolitinib
What this could lead to
If successful, this could offer a new treatment option for people with myelofibrosis who cannot have a stem cell transplant, potentially shrinking the spleen and easing symptoms.
What could go wrong
This is a Phase 2 trial, so results are still early. The combination may cause side effects or not work better than existing treatments. Success in this study does not guarantee approval or widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

191 people

The number who actually took part.

Started

Oct 2017

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with documented diagnosis of intermediate-2 or high-risk primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis or Post-essential Thrombocythemia Myelofibrosis. * Participant must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry. * Eastern Cooperative Oncology Group (ECOG) of 0, 1, or 2. * Prior treatment must meet at least one of the following criteria: * Prior or current treatment with ruxolitinib and no prior treatment with a Bromodomain and Extra-Terminal motif (BET) proteins inhibitor or another Janus Kinase 2 (JAK-2) inhibitor, and meet all of the following criteria: * Ruxolitinib treatment must meet at least one of the following criteria: * Ruxolitinib treatment for \>=24 weeks with lack of efficacy defined as a lack of spleen response (refractory) or a loss of spleen or symptom response (relapsed) * Ruxolitinib treatment for \<24 weeks with documented disease progression on spleen measurements while on ruxolitinib as defined in the protocol: * Ruxolitinib treatment for \>=28 days with intolerance defined as new red blood cell 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. * If receiving ruxolitinib at the time of screening, must currently be on a stable dose \>=10 mg twice daily of ruxolitinib for \>=4 weeks prior to the 1st dose of navitoclax. * Participant has at least 2 symptoms each with a score \>=3 or a total score of \>=12, as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days during screening prior to study drug dosing; OR * Prior treatment with a JAK-2 inhibitor and meet one of the following criteria: * Prior treatment with a JAK-2 inhibitor for at least 12 weeks * Prior treatment with a JAK-2 inhibitor for \>=28 days complicated by either development of red blood cell transfusion requirement (at least 2 units/month for 2 months) OR Grade \>= 3 adverse events of thrombocytopenia, anemia, hematoma and/or hemorrhage while on JAK-2 inhibitor treatment; OR * No prior treatment with a JAK-2 or BET inhibitor. * Participant has splenomegaly as defined in the protocol. * Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol. Exclusion Criteria: * Splenic irradiation within 6 months prior to screening, or prior splenectomy. * Leukemic transformation (\> 10% blasts in peripheral blood or bone marrow aspirate/biopsy). * Participant is currently on medications that interfere with coagulation (including warfarin) or platelet function within 3 days prior to the first dose of study drug or during the study treatment period with the exception of low dose aspirin (up to 100 mg/day) and low-molecular-weight heparin. * Prior therapy with a BH3 mimetic compound or stem cell transplantation. * Participant has received strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin) or moderate CYP3A inhibitors (e.g., fluconazole) within 14 days prior to the administration of the first dose of study drug.

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Conditions

The condition(s) this trial relates to.

myelofibrosis primary myelofibrosis Splenomegaly

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis (MF)

Contacts and locations

Locations

  • AOU Policlinico G. Rodolico - San Marco /ID# 214549

    Catania, 95123, Italy

  • ASST Papa Giovanni XXIII /ID# 214900

    Bergamo, 24127, Italy

  • ASST Sette Laghi - Ospedale Di Circolo E Fondazione Macchi Varese /ID# 214551

    Varese, 21100, Italy

  • ASST degli Spedali Civili di Brescia /ID# 230420

    Brescia, 25123, Italy

  • Aneurin Bevan University Health Board /ID# 230332

    Newport, NP18 3XQ, United Kingdom

  • Aomori Prefectural Central Hospital /ID# 221773

    Aomori, Aomori, 030-8553, Japan

  • Ascension Providence Southfield Cancer Center /ID# 223876

    Southfield, Michigan, 48075-3707, United States

  • Assuta Ashdod Medical Center /ID# 230396

    Ashdod, Southern District, 7747629, Israel

  • Azienda Ospedaliero Universitaria Careggi /ID# 214555

    Florence, Firenze, 50134, Italy

  • Baptist MD Anderson Cancer Center - Jacksonville /ID# 222548

    Jacksonville, Florida, 32207-8432, United States

  • Barwon Health /ID# 222430

    Geelong, Victoria, 3220, Australia

  • Belfast Health and Social Care Trust /ID# 216991

    Belfast, BT9 7AB, United Kingdom

  • Bend Memorial Clinic /ID# 224184

    Bend, Oregon, 97701, United States

  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230719

    Madrid, 28027, Spain

  • City of Hope /ID# 221395

    Duarte, California, 91010, United States

  • Clinical Hospital Dubrava /ID# 230504

    Zagreb, City of Zagreb, 10000, Croatia

  • Colorado Blood Cancer Institute /ID# 224250

    Denver, Colorado, 80218, United States

  • Dana-Farber Cancer Institute /ID# 162675

    Boston, Massachusetts, 02215, United States

  • Duplicate_American Oncology Partners of Maryland, PA /ID# 231299

    Bethesda, Maryland, 20817, United States

  • Duplicate_CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230718

    Pamplona, Navarre, 31008, Spain

  • Duplicate_Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 230306

    Budapest, 1097, Hungary

  • Duplicate_Dokkyo Medical University Saitama Medical Center /ID# 222332

    Koshigaya-shi, Saitama, 343-8555, Japan

  • Duplicate_Medical University of South Carolina /ID# 222597

    Charleston, South Carolina, 29425, United States

  • Duplicate_University General Hospital Attikon /ID# 230395

    Athens, Attica, 12462, Greece

  • Duplicate_University of Alberta Hospital - Division of Hematology /ID# 217698

    Edmonton, Alberta, T6G 2B7, Canada

  • Fiona Stanley Hospital /ID# 216809

    Murdoch, Western Australia, 6150, Australia

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214553

    Rome, Roma, 00168, Italy

  • Fujita Health University Hospital /ID# 221539

    Toyoake, Aichi-ken, 470-1192, Japan

  • Galilee Medical Center /ID# 230397

    Nahariya, Northern District, 2210001, Israel

  • General Hospital of Athens Laiko /ID# 230394

    Athens, Attica, 11527, Greece

  • Grande Ospedale Metropolitano Bianchi - Melacrino - Morelli P.O. Riuniti /ID# 230011

    Reggio Calabria, 89125, Italy

  • Guys and St Thomas NHS Foundation Trust /ID# 164110

    London, Greater London, SE1 9RT, United Kingdom

  • Hadassah Medical Center-Hebrew University /ID# 230310

    Jerusalem, Jerusalem, 91120, Israel

  • Henry Ford Hospital /ID# 162682

    Detroit, Michigan, 48202, United States

  • Hospital General Universitario Gregorio Maranon /ID# 214676

    Madrid, 28007, Spain

  • Hospital Regional Universitario de Malaga /ID# 230858

    Málaga, 29011, Spain

  • Hospital Universitario 12 de Octubre /ID# 214710

    Madrid, 28041, Spain

  • Hospital Universitario Germans Trias i Pujol /ID# 214704

    Badalona, Barcelona, 08916, Spain

  • Hospital Universitario Vall d'Hebron /ID# 222415

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria /ID# 214709

    Málaga, 29010, Spain

  • Hospital del Centro Comprensivo de Cancer de la UPR /ID# 222544

    San Juan, 00927, Puerto Rico

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 230012

    Bologna, Emilia-Romagna, 40138, Italy

  • Indiana Blood & Marrow Transpl /ID# 165075

    Indianapolis, Indiana, 46237, United States

  • Juntendo University Hospital /ID# 221484

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Kansai Medical University Hospital /ID# 222690

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kaohsiung Chang Gung Memorial Hospital /ID# 230371

    Kaohsiung City, Kaohsiung, 833, Taiwan

  • Kindai University Hospital /ID# 222689

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Klinicka bolnica Merkur /ID# 230599

    Zagreb, City of Zagreb, 10000, Croatia

  • Klinicki Bolnicki Centar (KBC) Split /ID# 230601

    Split, Split-Dalmatia County, 21000, Croatia

  • Klinicki bolnicki centar Zagreb /ID# 230602

    Zagreb, City of Zagreb, 10000, Croatia

  • Kyushu University Hospital /ID# 222691

    Fukuoka, Fukuoka, 812-8582, Japan

  • Long Beach Memorial Medical Ct /ID# 230148

    Long Beach, California, 90806-1701, United States

  • MD Anderson Cancer Center at Texas Medical Center /ID# 162683

    Houston, Texas, 77030-4000, United States

  • Mayo Clinic /ID# 164201

    Jacksonville, Florida, 32224, United States

  • McGill University Health Center Research Institute /ID# 223976

    Montreal, Quebec, H4A 3J1, Canada

  • Mid Illinois Hematology & Oncology Associates, Ltd /ID# 230536

    Normal, Illinois, 61761, United States

  • MidAmerica Division, Inc. /ID# 222058

    Kansas City, Missouri, 64132, United States

  • Moffitt Cancer Center /ID# 164082

    Tampa, Florida, 33612-9416, United States

  • Moores Cancer Center at UC San Diego /ID# 164084

    La Jolla, California, 92093, United States

  • National Cheng Kung University Hospital /ID# 230372

    Tainan, 704, Taiwan

  • Nippon Medical School Hospital /ID# 222692

    Bunkyo-ku, Tokyo, 113-8602, Japan

  • Oncology Consultants /ID# 230930

    Houston, Texas, 77030-3306, United States

  • Oxford University Hospitals NHS Foundation Trust /ID# 214503

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Peter MacCallum Cancer Ctr /ID# 218352

    Melbourne, Victoria, 3000, Australia

  • Prairie Lakes Healthcare System /ID# 224358

    Watertown, South Dakota, 57201, United States

  • Samsung Medical Center /ID# 230381

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Sapporo Hokuyu Hospital /ID# 222693

    Sapporo, Hokkaido, 003-0006, Japan

  • Semmelweis Egyetem /ID# 230518

    Budapest, 1085, Hungary

  • Seoul National University Hospital /ID# 230380

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 230585

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400, Hungary

  • TOI Clinical Research /ID# 222546

    Cerritos, California, 90703-2679, United States

  • Tel Aviv Sourasky Medical Center /ID# 230311

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Tennessee Oncology-Nashville Centennial /ID# 221410

    Nashville, Tennessee, 37203-1632, United States

  • Texas Oncology - West Texas /ID# 224784

    Abilene, Texas, 79606, United States

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 225159

    Dallas, Texas, 75246-2003, United States

  • The Alfred Hospital /ID# 215545

    Melbourne, Victoria, 3004, Australia

  • The Christie Hospital /ID# 164111

    Manchester, M20 4BX, United Kingdom

  • The Kinghorn Cancer Centre /ID# 214657

    Darlinghurst, New South Wales, 2010, Australia

  • The Ohio State University /ID# 217402

    Columbus, Ohio, 43210-1280, United States

  • UAB Comprehensive Cancer Cente /ID# 165464

    Birmingham, Alabama, 35217, United States

  • University Health Network_Princess Margaret Cancer Centre /ID# 214483

    Toronto, Ontario, M5G 2M9, Canada

  • University of Chicago Medicine /ID# 164115

    Chicago, Illinois, 60637-1426, United States

  • University of Massachusetts - Worcester /ID# 222547

    Worcester, Massachusetts, 01655, United States

  • University of Southern California /ID# 164095

    Los Angeles, California, 90033, United States

  • University of Texas Health San Antonio MD Anderson Cancer Center /ID# 164094

    San Antonio, Texas, 78229, United States

  • University of Utah /ID# 164116

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

  • University of Yamanashi Hospital /ID# 221700

    Chuo-shi, Yamanashi, 409-3821, Japan

  • Utah Cancer Specialists Salt Lake Clinic /ID# 222806

    Salt Lake City, Utah, 84106, United States

  • VA Caribbean Healthcare System /ID# 222416

    San Juan, 00921-3201, Puerto Rico

  • Weill Cornell Medical College /ID# 162679

    New York, New York, 10065, United States

  • West Penn Hospital /ID# 222618

    Pittsburgh, Pennsylvania, 15224-1722, United States

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