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New combo therapy aims to shrink spleen and ease symptoms in hard-to-treat myelofibrosis

NCT ID NCT04551053

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the experimental drug parsaclisib to the standard drug ruxolitinib helps people with myelofibrosis whose spleen and symptoms haven't improved enough on ruxolitinib alone. The main goal was to see if the combination could shrink the spleen by at least 25% after 24 weeks. The study was stopped early and involved 177 adults with different types of myelofibrosis.

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

177 people

The number who actually took part.

Started

May 2021

Finished

Aug 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. * Treated with ruxolitinib for ≥ 3 months with a stable dose for at least the last 8 weeks prior to Day 1 * 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 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 used for MF (whether for treatment of MF or another indication) with the exception of ruxolitinib, within 3 months of starting study drug, and/or lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better. * 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 * Unwillingness to receive RBC transfusions to treat low hemoglobin levels. * Known hypersensitivity or severe reaction to parsaclisib or ruxolitinib or excipients of parsaclisib/matching placebo or ruxolitinib formulations.

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Conditions

The condition(s) this trial relates to.

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, 8800, Belgium

  • Advent Health Hendersonville Park Ridge Hospital Hendersonville

    Clyde, North Carolina, 28721, United States

  • Akershus University Hospital

    Lorenskog, 01478, Norway

  • Aou Policlinico Consorziale Di Bari

    Bari, 70124, Italy

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

    Paris, 75010, France

  • Assuta Ramat Hahayal

    Tel Aviv, 69710, Israel

  • Augusta University - Medical College of Georgia

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

    Catania, 11111, Italy

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, 90146, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Avellino, 83100, Italy

  • Azienda Ospedaliera San Giuseppe Moscati

    Taranto, 74123, Italy

  • Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

    Siena, 53100, Italy

  • Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

    Udine, 33100, Italy

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Baskent University Adana Hospital

    Adana, 01250, Turkey (Türkiye)

  • Baskent University Istanbul Hospital

    Istanbul, 34662, Turkey (Türkiye)

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CCARE

    Fresno, California, 93720, United States

  • CHU Limoges - Hopital Duputren

    Limoges, 87042, France

  • 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

  • China Medical University Hospital

    Taichung, 00404, Taiwan

  • Chu Nimes

    Nîmes, 30900, France

  • Chu Ucl Namur University Hospital Mont-Godinne

    Yvoir, 05530, Belgium

  • Chu Vandoeuvre-Les-Nancy Hopital Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • Chu de Limoges

    Limoges, 87042, France

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Coastal Integrated Cancer Care - Cicc

    San Luis Obispo, California, 93401, United States

  • Dokkyo Medical University Saitama Medical Center

    Saitama, 343-8555, Japan

  • Duke Cancer Center

    Durham, North Carolina, 27710, United States

  • Ege University Hospital

    Izmir, 35040, Turkey (Türkiye)

  • Emad Ibrahim Md Inc

    Redlands, California, 92373, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fondazione Irccs Ca Granda Ospedale Maggiore

    Milan, 20122, Italy

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Fundacion Jimenez Diaz University Hospital

    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

  • Grampian Health Board

    Aberdeen, AB15 6RE, United Kingdom

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

    Reggio Calabria, 89133, Italy

  • Hadassah Hebrew University Medical Center Ein Karem Hadassah

    Jerusalem, 91120, Israel

  • 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 Cancer Hostipal

    Zhengzhou, 450008, China

  • Henan Provincial Peoples Hospital

    Zhengzhou, 450003, China

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232, United States

  • 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, 03010, Spain

  • Hospital Saint Antoine

    Paris, 75012, France

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46000, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 24041, Spain

  • Hospital Universitario Doctor Peset

    Valencia, 46017, Spain

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120, Spain

  • Hospital of the University of Occupation and Environmental Health

    Kitakyushu-shi, 807-8556, Japan

  • Ico Hospital Germans Trias I Pujol

    Badalona, 08916, Spain

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

    Barcelona, 08908, Spain

  • Institut Universitaire Du Cancer de Toulouse Oncopole

    Toulouse, 31059, France

  • Institute of Hematology and Hospital of Blood Diseases, Chinese Academy of Medical Sciences and Pek

    Tianjin, 510080, China

  • Institute of Hematology and Transfusion Medicine

    Warsaw, 02-776, Poland

  • Irccs Azienda Ospedaliera Universitaria San Martino

    Genova, 16132, Italy

  • Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • James Cook University Hospital

    Middlesbrough, TS4 3BW, United Kingdom

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, 453-8511, Japan

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, 670-8540, Japan

  • Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Jiangsu Province Hospital

    Nanjing, 210029, China

  • Jiangxi Provincial of People Hospital

    Nanchang, 330000, China

  • Jinan Central Hospital

    Jinan, 250013, China

  • Juntendo University Hospital

    Izunokuni, 410-2211, Japan

  • Juntendo University Hospital

    Tokyo, 113-8431, Japan

  • Kagoshima University Hospital

    Kagoshima, 890-8520, Japan

  • Kansai Medical University Hospital

    Hirakata, 573-1191, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301, Taiwan

  • Kaplan Medical Center

    Rehovot, 76100, Israel

  • Kelsey Seybold Clinic

    Houston, Texas, 77025, United States

  • 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

  • Markhot Ferenc Korhaz

    Eger, 03300, Hungary

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Midamerica Cancer Care

    Kansas City, Missouri, 64114, United States

  • 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

  • National Cheng Kung University (Ncku) Hospital

    Tainan, 00704, Taiwan

  • New Jersey Hematology Oncology Associates Llc

    Brick, New Jersey, 08724, United States

  • Nippon Medical School Hospital

    Tokyo, 113-8603, Japan

  • Ogaki Municipal Hospital

    Ōgaki, 5038502, Japan

  • Ondokuz Mayis University Medicine Faculty

    Samsun, 55200, Turkey (Türkiye)

  • Oregon Health & Science University

    Columbus, Ohio, 43210, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Osaka Metropolitan University Hospital

    Osaka, 545-8585, Japan

  • Ospedale S.Maria Della Misericordia

    Perugia, 06156, Italy

  • Ospedale S.Maria Della Misericordia

    Perugia, 6156, Italy

  • Ospedale Sant. Eugenio

    Roma, 144, Italy

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

    Beijing, 100044, China

  • Peking University Third Hospital

    Beijing, 100091, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Petz Aladar County Teaching Hospital

    Győr, 09024, Hungary

  • 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, 40-040, Poland

  • Pratia Hematologia Katowice

    Katowice, 41-081, Poland

  • Presidio Ospedaliero Pescara

    Pescara, 65124, Italy

  • Providence Regional Medical Center Everett

    Everett, Washington, 98201, United States

  • Pusan National University Yangsan Hospital

    Busan, 49241, South Korea

  • Rambam Health Care Campus

    Haifa, 31999, Israel

  • Renovatio Clinical

    Houston, Texas, 77005, United States

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081, Poland

  • Samodzielny Publiczny Zoz Szpital Uniwersytecki W Krakowie

    Krakow, 31-501, Poland

  • Samson Assuta Ashdod University Hospital

    Ashdod, 7747629, Israel

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Scripps Clinic

    San Diego, California, 92103, United States

  • Semmelweis Egyetem

    Budapest, 01088, Hungary

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shenzhen University Hospital

    Shenzhen, 518055, China

  • Spitalul Clinic Coltea - Clinica Hematologie

    Bucharest, 30171, Romania

  • Spitalul Clinic Judetean de Urgenta Targu Mures

    Târgu Gânguleşti, 540139, Romania

  • 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

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75246-2092, United States

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230, United States

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, 10050, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003, China

  • The Catholic University of Korea Seoul St. Mary?S Hospital

    Seoul, 06591, South Korea

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006, China

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou, 310003, China

  • The First Hospital of China Medical University

    Shenyang, 110001, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The First Hospital of Lanzhou University

    Lanzhou, 730000, China

  • The First Peoples Hospital of Changzhou

    Changzhou, 213003, China

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, 650101, China

  • The Second Affiliated Hospital of Xi an Jiaotong University

    Xi'an, 710004, China

  • Tianjin Medical University General Hospital

    Tianjin, 300052, China

  • Tokai University Hospital

    Isehara, 2591193, Japan

  • Tongji Hospital Huazhong University of Science and Technology

    Wuhan, 430030, China

  • Tulane University

    New Orleans, Louisiana, 70112, 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

  • Univ. Di Roma Facolta Di Armacia E Medicina

    Roma, 00161, Italy

  • Universita Di Napoli Federico Ii

    Naples, 80131, Italy

  • Universitaetsmedizin Greifswald

    Greifswald, 17475, Germany

  • Universitaetsmedizin Rostock

    Rostock, 18057, Germany

  • Universitatsklinikum Bonn Aoer

    Bonn, 53127, Germany

  • Universitatsklinikum Halle (Saale)

    Halle, 06120, Germany

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2BU, United Kingdom

  • University of Florence

    Florence, 50134, Italy

  • University of Kansas Hospital Authority

    Westwood, Kansas, 66205, United States

  • University of Miyazaki Hospital

    Miyazaki, 889-1692, Japan

  • University of Science and Technology of China-First Affiliated Hospital (Anhui Provincial Hospital)

    Hefei, 230022, China

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-8565, United States

  • University of Yamanashi Hospital

    Yamanashi, 409-3898, Japan

  • Westchester Medical Center Advanced Oncology

    Hawthorne, New York, 10532, United States

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

  • Yantai Yuhuangding Hospital

    Yantai, 264000, China

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