2023-504724-25-00RecruitingPhase 3
Adding Navtemadlin to Ruxolitinib for Patients with Myelofibrosis
A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Sept 2026
Brief summary (registry, in English)
Co-primary objectives: To compare spleen volume reduction (SVR) between Arm 1 and Arm 2 To compare total symptom score (TSS) reduction between Arm 1 and Arm 2
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 24 May 2024
- Start date
- 16 Oct 2024
- Lead sponsor
- Kartos Therapeutics Inc.
- Diseases
- Myeloproliferative neoplasms
- EU CT number
- 2023-504724-25-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 126
- 122 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with myelofibrosis who have not had a JAK inhibitor before. Those who respond poorly to ruxolitinib can then be randomised to add navtemadlin or placebo.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Primary myelofibrosis, or myelofibrosis after polycythemia vera or after essential thrombocythemia. Risk category High, Intermediate-1 or Intermediate-2 (IPSS). ECOG performance status 0 to 2.
- Earlier treatment
- No earlier JAK inhibitor treatment. For the add-on part: a stable dose of ruxolitinib and a suboptimal response to the ruxolitinib run-in.
- Biomarker or test result
- For the add-on part: TP53 wild type (TP53WT), checked by central testing.
Main reasons for not taking part
- Previous removal of the spleen (splenectomy)
- Radiation to the spleen within 3 months before the first dose
- Earlier treatment with BCL-XL, BET, MDM2, PI3K, PIM or XPO1 inhibitors, or p53-directed therapy
- Able to have a bone marrow transplant
- Blast cells in blood or bone marrow at 10% or more
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ruxolitinib Run-In Period: 1. Prior Splenectomy
- Ruxolitinib Run-In Period: 2. Splenic irradiation within 3 months prior to the first dose
- Ruxolitinib Run-In Period: 3. Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53- directed therapy
- Ruxolitinib Run-In Period: 4. Eligible for Bone Marrow Transplant
Lab values
- Ruxolitinib Run-In Period: 5. Peripheral blood or bone marrow blast count ≥ 10%
- Randomized Period: 1. Peripheral blood or bone marrow blast count ≥ 10%
Who the study is looking for
- Ruxolitinib Run-In Period: 1. Adults ≥ 18 years of age able to provide informed consent.
- Ruxolitinib Run-In Period: 2. 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
- Ruxolitinib Run-In Period: 3. High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- Ruxolitinib Run-In Period: 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Ruxolitinib Run-In Period: 5. JAK-inhibitor treatment naive
- Randomized Add-on Period: 1. PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing.
- Randomized Add-on Period: 2. ECOG performance status of 0 to 2.
- Randomized Add-on Period: 3. Treatment with a stable dose of ruxolitinib
- Randomized Add-on Period: 4. Suboptimal response to run-in ruxolitinib therapy
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (122)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck | Innsbruck | Austria | Recruiting |
| Steiermaerkische Krankenanstalten Ges.m.b.H. | Leoben | Austria | Recruiting |
| Johannes Kepler University Linz | Linz | Austria | Recruiting |
| Ordensklinikum Linz GmbH | Linz | Austria | Recruiting |
| Stadt Wien Wiener Gesundheitsverbund | Vienna | Austria | Recruiting |
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Het Ziekenhuisnetwerk Antwerpen | Antwerp | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | Recruiting |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Recruiting |
| Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur | Yvoir | Belgium | Recruiting |
| Fakultni Nemocnice Brno | Brno-Stred | Czechia | Recruiting |
| Fakultni Nemocnice Hradec Kralove | Novy Hradec Kralove | Czechia | Recruiting |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady | Prague | Czechia | Recruiting |
| Institute of Hematology and Blood Transfusion | Prague | Czechia | Recruiting |
| Gemeinschaftspraxis Haematologie Onkologie | Dresden | Germany | Recruiting |
| Marien Hospital Duesseldorf GmbH | Duesseldorf | Germany | Recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| Martin-Luther-Universitaet Halle-Wittenberg | Halle (Saale) | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover | Hanover | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Recruiting |
| Universitaetsklinikum Jena KöR | Jena | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR | Kiel | Germany | Recruiting |
| MVZ Leipzig Mitte | Leipzig | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR | Munich | Germany | Recruiting |
| Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts | Mutlangen | Germany | Recruiting |
| Klinikum Nuernberg | Nuremberg | Germany | Recruiting |
| Robert Bosch Krankenhaus GmbH | Stuttgart | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Recruiting |
| Institut Catala d'Oncologia | Badalona | Spain | Recruiting |
| Hospital del Mar | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| El Hospital Universitario De Gran Canaria Dr. Negrin | Las Palmas De Gran Canaria | Spain | Recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain | Recruiting |
| University Hospital Son Espases | Palma | Spain | Recruiting |
| Hospital Universitario De Salamanca | Salamanca | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Recruiting |
| Hospital QuirónSalud Zaragoza | Zaragoza | Spain | Recruiting |
| Centre Hospitalier Universitaire Amiens Picardie | Amiens Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest | Brest | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Centre Hospitalier Universitaire de Nîmes | Nîmes | France | Recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex 2 | France | Recruiting |
| Institut Universitaire du Cancer Toulouse - Oncopole | Toulouse | France | Recruiting |
| Centre Hospitalier Régional Universitaire de Tours | Tours | France | Recruiting |
| Laiko General Hospital of Athens | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Greece | Recruiting |
| University General Hospital of Ioannina | Ioannina | Greece | Recruiting |
| General University Hospital Of Patras | Patras | Greece | Recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou | Thessaloniki | Greece | Recruiting |
| Clinical Hospital Dubrava | Grad Zagreb | Croatia | Recruiting |
| Poliklinika Solmed d.o.o. | Grad Zagreb | Croatia | Recruiting |
| Clinical Hospital Centre Rijeka | Rijeka | Croatia | Recruiting |
| General Hospital Sibenik | Šibenik | Croatia | Recruiting |
| KBC Split | Split | Croatia | Recruiting |
| University Hospital Centre Zagreb | Zagreb | Croatia | Recruiting |
| Klinicka bolnica Merkur | Zagreb | Croatia | Recruiting |
| Semmelweis University | Budapest VIII | Hungary | Recruiting |
| Szabolcs Szatmár Bereg Vármegyei Oktatókórház | Nyíregyháza | Hungary | Recruiting |
| Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz | Szekesfehervar | Hungary | Recruiting |
| Tolna Varmegyei Balassa Janos Korhaz | Szekszárd | Hungary | Recruiting |
| Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo | Alexandria | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi | Ancona | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Italy | Recruiting |
| Careggi University Hospital | Florence | Italy | Recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Maggiore della Carità | Novara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo | Italy | Recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Recruiting |
| Azienda Ospedaliera Ospedali Riuniti Marche Nord | Pesaro | Italy | Recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia | Reggio Emilia | Italy | Recruiting |
| Azienda Sanitaria Locale Roma 2 | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi | Varese | Italy | Recruiting |
| "InterHem" Katarzyna Mazgajska-Barczyk, Marek Milewski, Jarosław Piszcz, Piotr Radziwon Sp. j | Białystok | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | Recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie | Cracow | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o | Katowice | Poland | Recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Lodz | Poland | Recruiting |
| Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ | Nowy Sacz | Poland | Recruiting |
| Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie | Olsztyn | Poland | Recruiting |
| Aidport sp z o.o. | Skorzewo | Poland | Recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. | Slupsk | Poland | Recruiting |
| Centrum Medyczne Damiana Holding Sp. z o.o. | Szczecin | Poland | Recruiting |
| Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu | Torun | Poland | Recruiting |
| Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego | Walbrzych | Poland | Recruiting |
| Clinical Best Solutions Sp. z o.o. S.K. | Warsaw | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | Poland | Recruiting |
| Unidade Local De Saude Da Regiao De Aveiro E.P.E. | Aveiro | Portugal | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude Do Alto Minho E.P.E. | Viana do Castelo | Portugal | Recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E | Vila Nova de Gaia | Portugal | Recruiting |
| Onco Card S.R.L. | Brasov | Romania | Recruiting |
| Spitalul Clinic Colentina Bucuresti | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca | Cluj-Napoca | Romania | Recruiting |
| Spitalul Clinic Judetean De Urgenta Bihor | Oradea | Romania | Recruiting |
| Spitalul Clinic Judetean de Urgenta Targu Mures | Târgu Mureş | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.