Hope for myelofibrosis patients: new drug combo aims to shrink spleens and ease symptoms

NCT ID NCT06479135

Disease control Sponsor: Kartos Therapeutics, Inc. Source: ClinicalTrials.gov ↗

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

Summary

This study tests whether adding navtemadlin to the standard drug ruxolitinib helps people with myelofibrosis who aren't getting enough benefit from ruxolitinib alone. About 600 adults with myelofibrosis will first take ruxolitinib, then those with a poor response will be randomly assigned to also get navtemadlin or a placebo. The main goals are to see if the combination reduces spleen size and improves symptoms after 24 weeks.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

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 for Ruxolitinib Alone Period: * Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria * High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * JAK-inhibitor treatment naive Exclusion Criteria for Ruxolitinib Alone Period: * Prior Splenectomy * Splenic irradiation within 3 months prior to the first dose * Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53-directed therapy * Eligible for Bone Marrow Transplant * Peripheral blood or bone marrow blast count ≥ 10 percent Inclusion Criteria for Randomized Period: * PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing * ECOG performance status of 0 to 2 * Treatment with a stable dose of ruxolitinib * Suboptimal response to run-in ruxolitinib treatment Exclusion Criteria for Randomized Period: * Elevated white blood cell count that doubles (or more) during ruxolitinib treatment and exceeds 50 × 10\^9/L * Peripheral blood or bone marrow blast count ≥ 10 percent

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

acquired polycythemia vera mycosis fungoides myelofibrosis primary myelofibrosis

As listed by the trial registrant

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

MF Myelofibrosis Post-et myelofibrosis Post-PV MF Primary myelofibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

214 sites in 19 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

"InterHem" General Partnership
RECRUITING

Bialystok, Poland
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Hematology Department
RECRUITING

Cluj-Napoca, 400015, Romania
AIDPORT
RECRUITING

Poznan, 60-185, Poland
ASST Sette Laghi Hospital
RECRUITING

Varese, Italy
ASST Spedali Civili Brescia
RECRUITING

Brescia, Italy
Abramson Cancer Center of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Addenbrooke's Hospital
RECRUITING

Cambridge, CB2 0QQ, United Kingdom
AdventHealth Cancer Institute
RECRUITING

Orlando, Florida, 32803, United States
Amiens Picardie University Hospital - South
RECRUITING

Amiens, 59037, France
Angers University Hospital Center
RECRUITING

Angers, France
Antwerp Hospital Network (ZNA) Cadix
RECRUITING

Antwerp, 2030, Belgium
Archet 1 and 2 hospital
RECRUITING

Nice, 06200, France
Asan Medical Center
RECRUITING

Seoul, 05505, South Korea
Atrium Health Levine Cancer Institute
RECRUITING

Charlotte, North Carolina, 28204, United States
Atrium Health Wake Forest Baptist
RECRUITING

Winston-Salem, North Carolina, 27157, United States
Banner MD Anderson Cancer Center
RECRUITING

Gilbert, Arizona, 85234, United States
Bihor County Emergency Clinical Hospital, Department of Hematology
RECRUITING

Oradea, 410469, Romania
Birmingham Heartlands Hospital
RECRUITING

Birmingham, B9 5SS, United Kingdom
Bordeaux University Hospital
RECRUITING

Pessac, France
Braga Hospital
RECRUITING

Braga, Portugal
Brookdale University Hospital and Medical Center
RECRUITING

Brooklyn, New York, 11212, United States
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
WITHDRAWN

Cáceres, 10003, Spain
Calvary Mater Newcastle Hospital
RECRUITING

Waratah, NSW 2298, Australia
Careggi University Hospital
RECRUITING

Florence, 50134, Italy
Catalan Institute of Oncology, Hospital Duran i Reynals
RECRUITING

Barcelona, Spain
Caucasus Medical Centre LLC
RECRUITING

Tbilisi, 0186, Georgia
Cayuga Cancer Center
RECRUITING

Ithaca, New York, 14850, United States
Central Hospital of Western Lisbon
RECRUITING

Lisbon, 1449-005, Portugal
Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
RECRUITING

Lisbon, 1649-035, Portugal
City of Health and Science of Turin
RECRUITING

Turin, 10126, Italy
Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States
Cleveland Clinic Cancer Center at Fairview Hospital
RECRUITING

Cleveland, Ohio, 44111, United States
Clinical Best Solutions LLC, Limited Partnership
RECRUITING

Warsaw, 00-710, Poland
Clinical Center of Vojvodina
RECRUITING

Novi Sad, Serbia
Clinical Hospital Center Bezanijska Kosa
RECRUITING

Belgrade, 7203, Serbia
Clinical Hospital Centre Rijeka
RECRUITING

Rijeka, 51 000, Croatia
Clinical Hospital Dubrava
RECRUITING

Zagreb, 10000, Croatia
Clinical Hospital Merkur
RECRUITING

Zagreb, 10000, Croatia
Colentina Clinical Hospital, Department of Hematology
RECRUITING

Bucharest, 020125, Romania
Dana Farber Cancer Institute
RECRUITING

Boston, Massachusetts, 02215, United States
Dom Lekarski Medical Center Outlet Park
RECRUITING

Szczecin, 70-784, Poland
Dr Alfred Sokolowski Specialty Hospital
RECRUITING

Wałbrzych, Poland
Duke University Medical Center
RECRUITING

Durham, North Carolina, 27710, United States
European Institute of Oncology (IEO), IRCCS
RECRUITING

Milan, Italy
Fejer County St. Gyorgy University Teaching Hospital
RECRUITING

Székesfehérvár, Hungary
Fred Hutchinson Cancer Centre
RECRUITING

Seattle, Washington, 98109, United States
Gabrail Cancer Center
RECRUITING

Canton, Ohio, 44718, United States
General Hospital Delta
RECRUITING

Roeselare, 8800, Belgium
General Hospital of Athens Laikon
RECRUITING

Athens, 115 27, Greece
General Hospital of Sibenik-Knin County
RECRUITING

Šibenik, 22000, Croatia
General Hospital of Thessaloniki "G. Papanikolaou"
RECRUITING

Thessaloniki, PC 57010, Greece
Genesis Care, Oxford
RECRUITING

Oxford, OX4 6LB, United Kingdom
Genesis Care, Windsor
RECRUITING

Windsor, SL4 3HD, United Kingdom
Gloucestershire Royal Hospital
RECRUITING

Gloucester, GL1 3NN, United Kingdom
Gosford Hospital
RECRUITING

Gosford, NSW 2250, Australia
Gran Canaria Dr Negrin University Hospital
RECRUITING

Las Palmas de Gran Canaria, 35010, Spain
Guy's Hospital
RECRUITING

London, SE1 9RT, United Kingdom
Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States
Hannover Medical School
RECRUITING

Hanover, Germany
Harrogate District Hospital
RECRUITING

Harrogate, HG2 7SX, United Kingdom
Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion
RECRUITING

Detroit, Michigan, 48202, United States
Hillcrest Hospital - Cleveland Clinic
RECRUITING

Mayfield Heights, Ohio, 44124, United States
Hospital Arcispedale S. Maria Nuova of Reggio Emilia
RECRUITING

Reggio Emilia, Italy
Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro
RECRUITING

Aveiro, 3810- 501, Portugal
Hospital Nuernberg, Campus North
RECRUITING

Nuremberg, 90419, Germany
Hospital Ottakring, Department of Internal Medicine I
RECRUITING

Vienna, 1160, Austria
Hospital Rechts der Isar
RECRUITING

Munich, 81675, Germany
Hospital S. Eugenio- Rome 2 ASL
RECRUITING

Rome, Italy
ICAHN School of Medicine at Mount Sinai
RECRUITING

New York, New York, 10029-6574, United States
Independence Family Health Center - Cleveland Clinic
RECRUITING

Independence, Ohio, 44131, United States
Independent Public Healthcare Facility University Hospital in Krakow
RECRUITING

Krakow, Poland
Inje University Busan Paik Hospital
RECRUITING

Busan, 47392, South Korea
Institute of Hematology and Blood Transfusion
RECRUITING

Prague, 12800, Czechia
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
RECRUITING

Forlì, 47014, Italy
JSC German Hospital
RECRUITING

Tbilisi, 0119, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
RECRUITING

Tbilisi, 0159, Georgia
JSC Vian
RECRUITING

Kutaisi, 4600, Georgia
Jan Mikulicz-Radecki Teaching Hospital in Wroclaw
RECRUITING

Wroclaw, Poland
Janusz Korczak Provincial Specialist Hospital
RECRUITING

Słupsk, 76-200, Poland
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz
RECRUITING

Nowy Sącz, 33 - 300, Poland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
RECRUITING

Baltimore, Maryland, 21231, United States
Keimyung University - Dongsan Medical Center
RECRUITING

Daegu, 42601, South Korea
Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology
RECRUITING

Linz, 4021, Austria
Kyungpook National University Hospital
RECRUITING

Daegu, 41944, South Korea
LEPL The First University Clinic of Tbilisi State Medical University
RECRUITING

Tbilisi, 0141, Georgia
Leicester Royal Infirmary
RECRUITING

Leicester, LE1 5WW, United Kingdom
Leon Berard Center
RECRUITING

Lyon, France
Lille Regional University Hospital Center
RECRUITING

Lille, 59037, France
Lincoln County Hospital
RECRUITING

Boston, Lincoln County Hospital, United Kingdom
Local Health Company of Pesaro and Urbino
RECRUITING

Pesaro, 61121, Italy
MVZ Mitte Am Johannisplatz
RECRUITING

Leipzig, 04103, Germany
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
RECRUITING

Milan, 20122, Italy
Marche University Hospital
RECRUITING

Ancona, 60126, Italy
Marien Hospital Duesseldorf GmbH
RECRUITING

Düsseldorf, 40479, Germany
Mary Bird Perkins Cancer Center
RECRUITING

Baton Rouge, Louisiana, 70809, United States
Mayo Clinic - Jacksonville
RECRUITING

Jacksonville, Florida, 32224, United States
Mayo Clinic - Phoenix
RECRUITING

Phoenix, Arizona, 85054, United States
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Medical Oncology Hematology Consultants, PA
RECRUITING

Newark, Delaware, 19713, United States
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
RECRUITING

Innsbruck, 6020, Austria
Medical University Vienna
RECRUITING

Vienna, 1090, Austria
Medical University of South Carolina (MUSC)
RECRUITING

Charleston, North Carolina, 29425-8900, United States
Mission Cancer + Blood
RECRUITING

Des Moines, Iowa, 50314, United States
Moffitt Cancer Center
RECRUITING

Tampa, Florida, 33612, United States
Mohtaseb Cancer Center and Blood Disorders
RECRUITING

Henderson, Nevada, 86442, United States
Monash Medical Center Clayton
RECRUITING

Clayton, VIC 3168, Australia
Montefiore Einstein Comprehensive Cancer Center
RECRUITING

The Bronx, New York, 10467, United States
Nantes University Hospital Center - Hotel Dieu Hospital
RECRUITING

Nantes, 44000, France
National Hospital SS. Antonio e Biagio e Cesare Arrigo
RECRUITING

Alessandria, Italy
Nebraska Hematology - Oncology, P.C.
RECRUITING

Lincoln, Nebraska, 68506, United States
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center
RECRUITING

Lodz, 93-513, Poland
Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology
RECRUITING

Nîmes, 30900, France
Northwell Health, R.J. Zuckerberg Cancer Center
RECRUITING

Lake Success, New York, 11042, United States
Northwest Medical Specialties, PLLC - Tacoma
RECRUITING

Tacoma, Washington, 98405, United States
Norton Cancer Institute
RECRUITING

Louisville, Kentucky, 40207, United States
Onco Card Srl
RECRUITING

Brasov, 500052, Romania
Oncology Center of Warmia and Mazury in Olsztyn
RECRUITING

Olsztyn, Poland
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Internal Medicine I - Hemato-Oncology
RECRUITING

Linz, 4020, Austria
Pilgrim Hospital
RECRUITING

Boston, PE21 9QS, United Kingdom
Polyclinic S. Orsola-Malpighi
RECRUITING

Bologna, 40138, Italy
Polyclinic San Matteo, IRCCS
RECRUITING

Pavia, Italy
Pusan National University Hospital
RECRUITING

Busan, 49241, South Korea
Quironsalud Zaragoza Hospital
RECRUITING

Zaragoza, 50006, Spain
Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology
RECRUITING

Leoben, 8700, Austria
Regional Medical Oncology Center
RECRUITING

Wilson, North Carolina, 27893, United States
Robert-Bosch-Hospital
RECRUITING

Stuttgart, 70376, Germany
Rocky Mountain Cancer Centers - Aurora
RECRUITING

Aurora, Colorado, 80012, United States
Royal Adelaide Hospital
RECRUITING

Adelaide, SA 5000, Australia
Royal Hobart Hospital (RHH)
RECRUITING

Hobart, Tasmania, 7000, Australia
Royal Perth Hospital
RECRUITING

Perth, 6000, Australia
Saint-Louis Hospital, Department of Adult Hematology
RECRUITING

Paris, Paris, 75010, France
Scripps Health, Prebys Cancer Center
RECRUITING

San Diego, California, 92103, United States
Semmelweis University
RECRUITING

Budapest, H-1088, Hungary
Seoul National University Hospital
RECRUITING

Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
RECRUITING

Seoul, 03722, South Korea
Sheboygan Cancer & Blood Specialists
RECRUITING

Sheboygan, Wisconsin, 53081, United States
Sir Charles Gairdner Hospital
RECRUITING

Nedlands, Western Australia, 6009, Australia
Solmed Clinic
RECRUITING

Zagreb, 10000, Croatia
Soon Chun Hyang University Hospital Seoul
RECRUITING

Seoul, 04401, South Korea
South Lyon Hospital Center
RECRUITING

Lyon, 69310, France
St George Hospital
RECRUITING

Kogarah, NSW 2217, Australia
Staufer Schwaebisch Gmuend Hospital
RECRUITING

Mutlangen, 73557, Germany
Strasbourg Europe Institut of Cancerology
RECRUITING

Strasbourg, 67200, France
Szabolcs-Szatmar-Bereg County Teaching Hospital
RECRUITING

Nyíregyháza, 4400, Hungary
Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit
RECRUITING

Târgu Mureş, 540136, Romania
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
RECRUITING

Tbilisi, 0144, Georgia
Tennessee Oncology
RECRUITING

Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
RECRUITING

Nashville, Tennessee, 37203, United States
The Alfred Hospital
RECRUITING

Melbourne, VIC 3004, Australia
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING

Seoul, 06591, South Korea
The Center for Cancer and Blood Disorders
RECRUITING

Bethesda, Maryland, 20817, United States
The Clatterbridge Cancer Center NHS Foundation Trust
RECRUITING

Liverpool, L7 8YA, United Kingdom
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
RECRUITING

Torrance, California, 90502, United States
The Royal Melbourne Hospital - Peter MacCallum Cancer Center
RECRUITING

Melbourne, VIC 3000, Australia
The University of Texas Health Science Center at San Antonio
RECRUITING

San Antonio, Texas, 78229, United States
Tolna County Hospital
RECRUITING

Szekszárd, H-7100, Hungary
Tours Regional University Hospital Center
RECRUITING

Tours, 37000, France
Townsville University Hospital
RECRUITING

Douglas, QLD 4814, Australia
U.T. MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States
UAB Hospital
RECRUITING

Birmingham, Alabama, 35233, United States
UC San Diego Moores Cancer Center
RECRUITING

La Jolla, California, 92037, United States
UCL Mont-Godinne University Hospitals
RECRUITING

Yvoir, 5530, Belgium
UCLA Hematology/Oncology Clinic - Los Angeles
RECRUITING

Los Angeles, California, 90095, United States
UT - SouthWestern
RECRUITING

Dallas, Texas, 75390, United States
University Clinical Center Kragujevac
RECRUITING

Kragujevac, 34 000, Serbia
University Clinical Center of Serbia
RECRUITING

Belgrade, 11000, Serbia
University Clinical Hospital of Salamanca
RECRUITING

Salamanca, 37007, Spain
University Clinical Hospital of Valencia
RECRUITING

Valencia, 46010, Spain
University College Hospital
RECRUITING

London, NW1 2PG, United Kingdom
University General Hospital "Attikon"
RECRUITING

Athens, PC 12462, Greece
University General Hospital of Ioannina
RECRUITING

Ioannina, Greece
University General Hospital of Patras
RECRUITING

Pátrai, 26504, Greece
University Hospital "G.Rodolico - San Marco"
RECRUITING

Catania, Italy
University Hospital "Maggiore della Carita" of Novara
RECRUITING

Novara, 28100, Italy
University Hospital 12 de Octubre
RECRUITING

Madrid, 28041, Spain
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
RECRUITING

Brno, 625 00, Czechia
University Hospital Center Sart-Tilman
RECRUITING

Liège, 4000, Belgium
University Hospital Center of Poitiers
RECRUITING

Poitiers, France
University Hospital Centre Zagreb
RECRUITING

Zagreb, 10000, Croatia
University Hospital Freiburg
RECRUITING

Freiburg im Breisgau, 79106, Germany
University Hospital Germans Trias i Pujol
RECRUITING

Badalona, 08916, Spain
University Hospital Graz, Department of Internal Medicine
RECRUITING

Graz, 8036, Austria
University Hospital Halle (Saale)
RECRUITING

Halle, 06120, Germany
University Hospital Hamburg-Eppendorf
RECRUITING

Hamburg, 20246, Germany
University Hospital Heidelberg
RECRUITING

Heidelberg, 69120, Germany
University Hospital Hradec Kralove
RECRUITING

Hradec Králové, 500 05, Czechia
University Hospital Jena
RECRUITING

Jena, 07747, Germany
University Hospital Kralovske Vinohrady
RECRUITING

Prague, 100 00, Czechia
University Hospital Ostrava
RECRUITING

Ostrava, 708 52, Czechia
University Hospital Ramon y Cajal
RECRUITING

Madrid, 28041, Spain
University Hospital San Luigi Gonzaga
RECRUITING

Orbassano, Italy
University Hospital Schleswig-Holstein
RECRUITING

Kiel, 24105, Germany
University Hospital Ulm
RECRUITING

Ulm, 89081, Germany
University Hospital Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
University Hospital Virgen de la Victoria
RECRUITING

Málaga, 29010, Spain
University Hospital of Split
RECRUITING

Split, 21000, Croatia
University Hospital of Toulouse, IUCT-Oncopole
RECRUITING

Toulouse, France
University Hospital of Wales
RECRUITING

Cardiff, CF14 4XW, United Kingdom
University Hospitals Leuven, Campus Gasthuisberg
RECRUITING

Leuven, 3000, Belgium
University Polyclinic Hospital "Paolo Giaccone" Palermo
RECRUITING

Palermo, Italy
University Teaching Centre, Hematology and Transplantology Clinic
RECRUITING

Gdansk, Poland
University and Polytechnic Hospital La Fe
RECRUITING

Valencia, 46026, Spain
University of Cincinnati Medical Center
RECRUITING

Cincinnati, Ohio, 45219, United States
University of Kansas Cancer Center - Westwood
RECRUITING

Westwood, Kansas, 66205, United States
University of Miami
RECRUITING

Miami, Florida, 33136, United States
University of Michigan Hospital
RECRUITING

Ann Arbor, Michigan, 48109, United States
University of Utah, Huntsman Cancer Institute
RECRUITING

Salt Lake City, Utah, 84112, United States
VCU Medical Center
RECRUITING

Richmond, Virginia, 23298, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States
Vila Nova de Gaia Central Hospital
RECRUITING

Vila Nova de Gaia, Portugal
Virginia Cancer Institute
RECRUITING

Richmond, Virginia, 23229, United States
Virginia Oncology Associates - Virginia Beach
RECRUITING

Virginia Beach, Virginia, 23456, United States
West Penn Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Western General Hospital, Lothian Health Board
RECRUITING

Edinburgh, EH4 2XU, United Kingdom
Willamette Valley Cancer Institute and Research Center
RECRUITING

Eugene, Oregon, 97401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.