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Myelofibrosis drug combo trial ends early – what it means

NCT ID NCT04551066

Disease control Sponsor: Incyte Corporation 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested whether adding parsaclisib to the standard drug ruxolitinib could better shrink the spleen and ease symptoms in people with myelofibrosis. The study enrolled 252 participants but was terminated early, so the full results are not available. The goal was to improve disease control for this bone marrow disorder.

What this could mean

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

Active substance
parsaclisib and ruxolitinib
What this could lead to
If successful, this combination could offer a new treatment option for myelofibrosis patients, potentially better controlling spleen enlargement and symptoms.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if the combination is more effective than ruxolitinib alone, and there may be unknown side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

252 people

The number who actually took part.

Started

May 2021

Finished

Nov 2024

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: * Diagnosis of PMF, PPV-MF, or PET-MF. * DIPSS risk category of intermediate-1, intermediate-2, or high. * Palpable spleen of ≥ 5 cm below the left costal margin on physical examination at the screening visit. * Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of ≥ 10 using the Screening Symptom Form. * Participants with an ECOG performance status score of 0, 1, or 2. * Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF. * Life expectancy of at least 24 weeks. * Willingness to avoid pregnancy or fathering children. Exclusion Criteria: * Prior use of any JAK inhibitor. * Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib). * Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1. * Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. * Recent history of inadequate bone marrow reserve. * Inadequate liver and renal function at screening. * Active bacterial, fungal, parasitic, or viral infection that requires therapy. * Active HBV or HCV infection that requires treatment or at risk for HBV reactivation. * Known HIV infection. * Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol. * Active invasive malignancy over the previous 2 years. * Splenic irradiation within 6 months before receiving the first dose of study drug. * Concurrent use of any prohibited medications. * Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements. * Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study. * Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy. * Currently breastfeeding or pregnant. * Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. * History of Grade 3 or 4 irAEs from prior immunotherapy. * Receipt of any live vaccine within 30 days of the first dose of study drug

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera myelofibrosis Myeloproliferative Disorders primary myelofibrosis

As listed by the trial registrant

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

Myelofibrosis Post-essential thrombocythemia myelofibrosis Post-polycythemia vera myelofibrosis Primary myelofibrosis

Contacts and locations

Locations

  • A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

    Varese, 21100, Italy

  • A.Z. St.-Jan A.V.

    Bruges, 08000, Belgium

  • AZ DELTA

    Roeselare, 08800, Belgium

  • Aalborg University Hospital

    Aalborg, 09000, Denmark

  • Affiliated Hospital of Hebei University

    Baoding, 71000, China

  • Akershus University Hospital

    L�RENSKOG, 01478, Norway

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508, United States

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Aormn Hospital Hematology and Bmt Center

    Pesaro, 61122, Italy

  • Aou San Giovanni Di Dio E Ruggi D'Aragona

    Salerno, 84131, Italy

  • Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

    Paris, 75010, France

  • Assuta Ramat Hahayal

    Tel Aviv, 69710, Israel

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57103, United States

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Taranto, 74123, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma)

    Verona, 37134, Italy

  • Azienda Policlinico Vittorio Emanuele

    Catania, 95123, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

    Udine, 33100, Italy

  • Barts Health Nhs Trust - St Bartholomews Hospital

    London, EC1A 7BE, United Kingdom

  • Baskent University Adana Hospital

    Adana, 01250, Turkey (Türkiye)

  • Baskent University Istanbul Hospital

    Istanbul, 34662, Turkey (Türkiye)

  • CCARE

    Fresno, California, 93720, United States

  • California Research Institute (Cri)

    Los Angeles, California, 90027-6005, United States

  • Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

    La Tronche, 38700, France

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Centre Hospitalier de Roubaix

    Roubaix, 59100, France

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    LE Chesnay-rocquencourt, 78157, France

  • Chiba Cancer Center

    Chiba, 260-8677, Japan

  • Chu Limoges - Hopital Dupuytren

    Limoges, 87042, France

  • Chu Nimes

    Nîmes, 30900, France

  • Chu de Rennes - Hospital Pontchaillou

    Rennes, 35033, France

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01000, Belgium

  • Coastal Integrated Cancer Care-Cicc

    San Luis Obispo, California, 93401, United States

  • Davidoff Cancer Center Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Dokkyo Medical University Saitama Medical Center

    Saitama, 343-8555, Japan

  • Dokuz Eylul University

    Izmir, 35340, Turkey (Türkiye)

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Ege University Hospital

    Izmir, 35040, Turkey (Türkiye)

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Fundacian Jimnez Diaz

    Madrid, 28040, Spain

  • Gazi University Hospital Gazi University Faculty of Medicine

    Ankara, 06500, Turkey (Türkiye)

  • Georgetown University

    Washington D.C., District of Columbia, 20057, United States

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN, United Kingdom

  • Grand Hospital de Charleroi

    Charleroi, 06000, Belgium

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, 89133, Italy

  • Guangdong Provincial of People Hospital

    Guangzhou, 510080, China

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120, Israel

  • Hanusch-Krankenhaus Der Wiener Gebietskrankenkasse

    Vienna, 01140, Austria

  • Hanusch-Krankenhaus Wiener Gebietskrankenkasse

    Vienna, 01140, Austria

  • Harbin Institute of Hematology and Oncology

    Harbin, 150010, China

  • Haukeland University Hospital

    Bergen, 05021, Norway

  • Helsinki University Central Hospital

    Helsinki, FI-00029, Finland

  • Henan Provincial Peoples Hospital

    Zhengzhou, 450003, China

  • Hokuyukai Sapporo Hokuyu Hospital

    Sapporo, 003-0006, Japan

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Del Mar

    Barcelona, 08003, Spain

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008, Spain

  • Hospital General Universitario Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital General Unviersitario de Alicante

    Alicante, 3010, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46000, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Universitario Virgen de La Arrixaca

    El Palmar, 30120, Spain

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014, Spain

  • Hospital de Basurto

    Bilbao, 48013, Spain

  • Hospital de La Miletrie

    Poitiers, 86021, France

  • Hospital of the University of Occupation and Environmental Health

    Kitakyushu-shi, 807-8556, Japan

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Ico Hospital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Ico Hospital Germans Trias I Pujol

    Barcelona, 08916, Spain

  • Ico-Hospital Duran I Reynals

    Barcelona, 08908, Spain

  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

    Barcelona, 08908, Spain

  • Institute of Hematology and Transfusion Medicine

    Warsaw, 02-776, Poland

  • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milan, 20132, Italy

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori

    Meldola, 47014, Italy

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 453-8511, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, 670-8540, Japan

  • Jessa Ziekenhuis

    Hasselt, 03500, Belgium

  • Jiangsu Province Hospital

    Nanjing, 210029, China

  • Jiangxi Provincial of People Hospital

    Nanchang, 330000, China

  • Jinan Central Hospital

    Jinan, 250013, China

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kaiser Permanente-Northwest

    Portland, Oregon, 97227, United States

  • Kansai Medical University Hospital

    Hirakata, 573-1191, Japan

  • Kaplan Medical Center

    Rehovot, 76100, Israel

  • Kelsey Seybold Clinic

    Houston, Texas, 77025, United States

  • Klinikum Kassel Gmbh

    Kassel, 34125, Germany

  • Kobe City Medical Center General Hospital

    Kobe, 650-0047, Japan

  • Kumamoto Shinto General Hospital

    Kumamoto, 862-8655, Japan

  • Kyushu University Hospital

    Fukuoka, 812-8582, Japan

  • Lanzhou University Second Hospital

    Lanzhou, 730030, China

  • Lstituto Di Ematologia Lorenzo Ea.Seragnoli Universita Degli Studi Di Bologna - Policlinico S. Or

    Bologna, 40138, Italy

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Rochester

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Midamerica Cancer Care

    Kansas City, Missouri, 64114, United States

  • Mie University Hospital

    Tsu, 514-0001, Japan

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Morristown Medical Center-Atlantic Health System

    Morristown, New Jersey, 07960, United States

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Nanfang Hospital

    Guangzhou, 510515, China

  • New Jersey Hematology Oncology Associates Llc

    Brick, New Jersey, 08724, United States

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Odense University Hospital

    Odense, 05000, Denmark

  • Ogaki Municipal Hospital

    Ōgaki, 5038502, Japan

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Ondokuz Mayis University Medicine Faculty

    Samsun, 55200, Turkey (Türkiye)

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 04020, Austria

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585, Japan

  • Peking University People'S Hospital (Pkuph) - Institute of Hematology

    Beijing, 100044, China

  • Peking University Third Hospital

    Beijing, 100091, China

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Roma, 00168, Italy

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    Rome, 00168, Italy

  • Pratia Hematologia Katowice

    Katowice, 41-519, Poland

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201, United States

  • Rambam Health Care Campus

    Haifa, 31999, Israel

  • Renovatio Clinical

    Spring, Texas, 77380, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego

    Katowice, 40-027, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081, Poland

  • Samsung Medical Center

    Seoul, 03651, South Korea

  • Scripps Clinic

    San Diego, California, 92103, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shamir Medical Center Formerly Assaf Harofeh Medical Center

    BEER Yaaqov, 70300, Israel

  • Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital

    Sheffield, S5 7AT, United Kingdom

  • Shenzhen University Hospital

    Shenzhen, 518055, China

  • Sp Zoz Szpital Uniwersytecki

    Krakow, 31-501, Poland

  • Stamford Hospital-Medical Oncology Hematology

    Stamford, Connecticut, 06904, United States

  • Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704, United States

  • THE CATHOLIC UNIVERSITY OF KOREA SEOUL ST. MARY�S HOSPITAL

    Seoul, 06591, South Korea

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Oncology-Baylor Sammons Cancer Center

    Dallas, Texas, 75246-2092, United States

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 10050, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The First Hospital of Lanzhou University

    Lanzhou, 730000, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 50000, China

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tohoku University Hospital

    Sendai, 980-8574, Japan

  • Tokai University Hospital

    Isehara, 2591193, Japan

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • UCLA School of Medicine

    Los Angeles, California, 90095-3075, United States

  • Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, 430022, China

  • United Lincolnshire Hospitals

    Boston, PE21 9QS, United Kingdom

  • Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia

    Genova, 16132, Italy

  • Universita Di Napoli Federico Ii

    Naples, 80131, Italy

  • Universita Di Roma

    Roma, 00161, Italy

  • Universita Di Roma Tor Vergata

    Roma, 00133, Italy

  • Universitaetsklinikum St. Poelten

    Saint P�LTEN, 03100, Austria

  • Universitaetsmedizin Rostock

    Rostock, 18057, Germany

  • Universitatsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitatsklinikum Magdeburg A.O.R.

    Magdeburg, 39120, Germany

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2BU, United Kingdom

  • University Hospital of North Midlands Nhs Trust

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • University of Kansas Hospital Authority

    Westwood, Kansas, 66205, United States

  • University of Kentucky-Markey Cancer Center

    Lexington, Kentucky, 40536, United States

  • University of Miyazaki Hospital

    Miyazaki, 889-1692, Japan

  • University of Yamanashi Hospital

    Chūō, 409-3898, Japan

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Westchester Medical Center Advanced Oncology and Infusion Center

    Hawthorne, New York, 10532, United States

  • Wonju Severance Christian Hospital

    Wŏnju, 26426, South Korea

  • Xiangya Hospital Central South University

    Changsha, 410008, China

  • Yantai Yuhuangding Hospital

    Yantai, 264000, China

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855, Japan

  • Zhongshan Hospital Fudan University

    Shanghai, 200032, China

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