Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib (POIESIS)

September 22, 2025 updated by: Kartos Therapeutics, Inc.

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone.

Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: John Mei
Phone Number: 650-542-0136
Email: jmei@kartosthera.com

Study Locations

Australia
- - Adelaide, Australia, SA 5000
    - Recruiting
    - Royal Adelaide Hospital
  - Clayton, Australia, VIC 3168
    - Recruiting
    - Monash Medical Center Clayton
  - Douglas, Australia, QLD 4814
    - Recruiting
    - Townsville University Hospital
  - Gosford, Australia, NSW 2250
    - Recruiting
    - Gosford Hospital
  - Kogarah, Australia, NSW 2217
    - Recruiting
    - St George Hospital
  - Melbourne, Australia, VIC 3000
    - Recruiting
    - The Royal Melbourne Hospital - Peter MacCallum Cancer Center
  - Melbourne, Australia, VIC 3004
    - Recruiting
    - The Alfred Hospital
  - Perth, Australia, 6000
    - Recruiting
    - Royal Perth Hospital
  - Waratah, Australia, NSW 2298
    - Recruiting
    - Calvary Mater Newcastle Hospital
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Recruiting
    - Royal Hobart Hospital (RHH)
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Recruiting
    - Sir Charles Gairdner Hospital
Austria
- - Graz, Austria, 8036
    - Recruiting
    - University Hospital Graz, Department of Internal Medicine
  - Innsbruck, Austria, 6020
    - Recruiting
    - Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
  - Leoben, Austria, 8700
    - Recruiting
    - Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology
  - Linz, Austria, 4020
    - Recruiting
    - Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Internal Medicine I - Hemato-Oncology
  - Linz, Austria, 4021
    - Recruiting
    - Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology
  - Vienna, Austria, 1090
    - Recruiting
    - Medical University Vienna
  - Vienna, Austria, 1160
    - Recruiting
    - Hospital Ottakring, Department of Internal Medicine I
Belgium
- - Antwerp, Belgium, 2030
    - Recruiting
    - Antwerp Hospital Network (ZNA) Cadix
  - Leuven, Belgium, 3000
    - Recruiting
    - University Hospitals Leuven, Campus Gasthuisberg
  - Liège, Belgium, 4000
    - Recruiting
    - University Hospital Center Sart-Tilman
  - Roeselare, Belgium, 8800
    - Recruiting
    - General Hospital Delta
  - Yvoir, Belgium, 5530
    - Recruiting
    - UCL Mont-Godinne University Hospitals
Croatia
- - Rijeka, Croatia, 51 000
    - Recruiting
    - Clinical Hospital Centre Rijeka
  - Split, Croatia, 21000
    - Recruiting
    - University Hospital of Split
  - Zagreb, Croatia, 10000
    - Recruiting
    - University Hospital Centre Zagreb
  - Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Dubrava
  - Zagreb, Croatia, 10000
    - Recruiting
    - Solmed Clinic
  - Zagreb, Croatia, 10000
    - Recruiting
    - Clinical Hospital Merkur
  - Šibenik, Croatia, 22000
    - Recruiting
    - General Hospital of Sibenik-Knin County
Czechia
- - Brno, Czechia, 625 00
    - Recruiting
    - University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
  - Hradec Králové, Czechia, 500 05
    - Recruiting
    - University hospital Hradec Králové
  - Ostrava, Czechia, 708 52
    - Recruiting
    - University Hospital Ostrava
  - Prague, Czechia, 100 00
    - Recruiting
    - University Hospital Královské Vinohrady
  - Prague, Czechia, 12800
    - Recruiting
    - Institute of Hematology and Blood Transfusion
France
- - Amiens, France, 59037
    - Recruiting
    - Amiens Picardie University Hospital - South
  - Angers, France
    - Recruiting
    - Angers University Hospital Center
  - Lille, France, 59037
    - Recruiting
    - Lille Regional University Hospital Center
  - Lyon, France, 69310
    - Recruiting
    - South Lyon Hospital Center
  - Lyon, France
    - Recruiting
    - Léon Bérard Center
  - Nantes, France, 44000
    - Recruiting
    - Nantes University Hospital Center - Hotel Dieu Hospital
  - Nice, France, 06200
    - Recruiting
    - Archet 1 and 2 hospital
  - Nîmes, France, 30900
    - Recruiting
    - Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology
  - Pessac, France
    - Recruiting
    - Bordeaux University Hospital
  - Poitiers, France
    - Recruiting
    - University Hospital Center of Poitiers
  - Strasbourg, France, 67200
    - Recruiting
    - Strasbourg Europe Institut of Cancerology
  - Toulouse, France
    - Recruiting
    - University Hospital of Toulouse, IUCT-Oncopole
  - Tours, France, 37000
    - Recruiting
    - Tours Regional University Hospital Center
- Paris
  - Paris, Paris, France, 75010
    - Recruiting
    - Saint-Louis Hospital, Department of Adult Hematology
Georgia
- - Kutaisi, Georgia, 4600
    - Recruiting
    - JSC Vian
  - Tbilisi, Georgia, 0159
    - Recruiting
    - JSC K. Eristavi National Center of Experimental and Clinical Surgery
  - Tbilisi, Georgia, 0119
    - Recruiting
    - Jsc German Hospital
  - Tbilisi, Georgia, 0144
    - Recruiting
    - Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
  - Tbilisi, Georgia, 0141
    - Recruiting
    - LEPL The First University Clinic of Tbilisi State Medical University
  - Tbilisi, Georgia, 0186
    - Recruiting
    - Caucasus Medical Centre Llc
Germany
- - Düsseldorf, Germany, 40479
    - Recruiting
    - Marien Hospital Duesseldorf GmbH
  - Freiburg im Breisgau, Germany, 79106
    - Recruiting
    - University Hospital Freiburg
  - Halle, Germany, 06120
    - Recruiting
    - University Hospital Halle (Saale)
  - Hamburg, Germany, 20246
    - Recruiting
    - University Hospital Hamburg-Eppendorf
  - Hanover, Germany
    - Recruiting
    - Hannover Medical School
  - Heidelberg, Germany, 69120
    - Recruiting
    - University Hospital Heidelberg
  - Jena, Germany, 07747
    - Recruiting
    - University Hospital Jena
  - Kiel, Germany, 24105
    - Recruiting
    - University Hospital Schleswig-Holstein
  - Leipzig, Germany, 04103
    - Recruiting
    - MVZ Mitte Am Johannisplatz
  - Munich, Germany, 81675
    - Recruiting
    - Hospital Rechts der Isar
  - Mutlangen, Germany, 73557
    - Recruiting
    - Staufer Schwaebisch Gmuend Hospital
  - Nuremberg, Germany, 90419
    - Recruiting
    - Hospital Nuernberg, Campus North
  - Stuttgart, Germany, 70376
    - Recruiting
    - Robert-Bosch-Hospital
  - Ulm, Germany, 89081
    - Recruiting
    - University Hospital Ulm
Greece
- - Athens, Greece, PC 12462
    - Recruiting
    - University General Hospital "Attikon"
  - Athens, Greece, 115 27
    - Recruiting
    - General Hospital of Athens Laikon
  - Ioannina, Greece
    - Recruiting
    - University General Hospital of Ioannina
  - Pátrai, Greece, 26504
    - Recruiting
    - University General Hospital of Patras
  - Thessaloniki, Greece, PC 57010
    - Recruiting
    - General Hospital of Thessaloniki "G. Papanikolaou"
Hungary
- - Budapest, Hungary, H-1088
    - Recruiting
    - Semmelweis University
  - Nyíregyháza, Hungary, 4400
    - Recruiting
    - Szabolcs-Szatmar-Bereg County Teaching Hospital
  - Szekszárd, Hungary, H-7100
    - Recruiting
    - Tolna County Hospital
  - Székesfehérvár, Hungary
    - Recruiting
    - Fejer County St. Gyorgy University Teaching Hospital
Italy
- - Alessandria, Italy
    - Recruiting
    - National Hospital SS. Antonio e Biagio e Cesare Arrigo
  - Ancona, Italy, 60126
    - Recruiting
    - Marche University Hospital
  - Bologna, Italy, 40138
    - Recruiting
    - Polyclinic S. Orsola-Malpighi
  - Brescia, Italy
    - Recruiting
    - ASST Spedali Civili Brescia
  - Catania, Italy
    - Recruiting
    - University Hospital "G.Rodolico - San Marco"
  - Florence, Italy, 50134
    - Recruiting
    - Careggi University Hospital
  - Forlì, Italy, 47014
    - Recruiting
    - Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
  - Milan, Italy
    - Recruiting
    - European Institute of Oncology (IEO), IRCCS
  - Milan, Italy, 20122
    - Recruiting
    - Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
  - Novara, Italy, 28100
    - Recruiting
    - University Hospital "Maggiore della Carita" of Novara
  - Orbassano, Italy
    - Recruiting
    - University Hospital San Luigi Gonzaga
  - Palermo, Italy
    - Recruiting
    - University Polyclinic Hospital "Paolo Giaccone" Palermo
  - Pavia, Italy
    - Recruiting
    - Polyclinic San Matteo, IRCCS
  - Pesaro, Italy, 61121
    - Recruiting
    - Local Health Company of Pesaro and Urbino
  - Reggio Emilia, Italy
    - Recruiting
    - Hospital Arcispedale S. Maria Nuova of Reggio Emilia
  - Rome, Italy
    - Recruiting
    - Hospital S. Eugenio- Rome 2 ASL
  - Turin, Italy, 10126
    - Recruiting
    - City of Health and Science of Turin
  - Varese, Italy
    - Recruiting
    - ASST Sette Laghi Hospital
Poland
- - Bialystok, Poland
    - Recruiting
    - "InterHem" General Partnership
  - Gdansk, Poland
    - Recruiting
    - University Teaching Centre, Hematology and Transplantology Clinic
  - Krakow, Poland
    - Recruiting
    - Independent Public Healthcare Facility University Hospital in Krakow
  - Lodz, Poland, 93-513
    - Recruiting
    - Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center
  - Nowy Sącz, Poland, 33 - 300
    - Recruiting
    - Jedrzej Sniadecki Specialist Hospital in Nowy Sacz
  - Olsztyn, Poland
    - Recruiting
    - Oncology Center of Warmia and Mazury in Olsztyn
  - Poznan, Poland, 60-185
    - Recruiting
    - Aidport
  - Szczecin, Poland, 70-784
    - Recruiting
    - Dom Lekarski Medical Center Outlet Park
  - Słupsk, Poland, 76-200
    - Recruiting
    - Janusz Korczak Provincial Specialist Hospital
  - Warsaw, Poland, 00-710
    - Recruiting
    - Clinical Best Solutions LLC, Limited Partnership
  - Wałbrzych, Poland
    - Recruiting
    - Dr Alfred Sokolowski Specialty Hospital
  - Wroclaw, Poland
    - Recruiting
    - Jan Mikulicz-Radecki Teaching Hospital in Wroclaw
Portugal
- - Aveiro, Portugal, 3810- 501
    - Recruiting
    - Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro
  - Braga, Portugal
    - Recruiting
    - Braga Hospital
  - Lisbon, Portugal, 1449-005
    - Recruiting
    - Central Hospital of Western Lisbon
  - Lisbon, Portugal, 1649-035
    - Recruiting
    - Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
  - Vila Nova de Gaia, Portugal
    - Recruiting
    - Vila Nova de Gaia Central Hospital
Romania
- - Brasov, Romania, 500052
    - Recruiting
    - Onco Card Srl
  - Bucharest, Romania, 020125
    - Recruiting
    - Colentina Clinical Hospital, Department of Hematology
  - Cluj-Napoca, Romania, 400015
    - Recruiting
    - "Prof. Dr. Ion Chiricuta" Institute of Oncology, Hematology Department
  - Oradea, Romania, 410469
    - Recruiting
    - Bihor County Emergency Clinical Hospital, Department of Hematology
  - Târgu Mureş, Romania, 540136
    - Recruiting
    - Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit
Serbia
- - Belgrade, Serbia, 11000
    - Recruiting
    - University Clinical Center of Serbia
  - Belgrade, Serbia, 7203
    - Recruiting
    - Clinical Hospital Center Bezanijska Kosa
  - Kragujevac, Serbia, 34 000
    - Recruiting
    - University Clinical Center Kragujevac
  - Novi Sad, Serbia
    - Recruiting
    - Clinical Center of Vojvodina
South Korea
- - Busan, South Korea, 49241
    - Recruiting
    - Pusan National University Hospital
  - Busan, South Korea, 47392
    - Recruiting
    - Inje University Busan Paik Hospital
  - Daegu, South Korea, 41944
    - Recruiting
    - Kyungpook National University Hospital
  - Daegu, South Korea, 42601
    - Recruiting
    - Keimyung University - Dongsan Medical Center
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 04401
    - Recruiting
    - Soon Chun Hyang University Hospital Seoul
  - Seoul, South Korea, 06591
    - Recruiting
    - The Catholic University of Korea, Seoul St. Mary's Hospital
Spain
- - Badalona, Spain, 08916
    - Recruiting
    - University Hospital Germans Trias i Pujol
  - Barcelona, Spain, 08035
    - Recruiting
    - University Hospital Vall d'Hebron
  - Barcelona, Spain
    - Recruiting
    - Catalan Institute of Oncology, Hospital Duran i Reynals
  - Cáceres, Spain, 10003
    - Withdrawn
    - Caceres Hospital Complex - San Pedro de Alcantara General Hospital
  - Las Palmas de Gran Canaria, Spain, 35010
    - Recruiting
    - Gran Canaria Dr Negrin University Hospital
  - Madrid, Spain, 28041
    - Recruiting
    - University Hospital 12 de Octubre
  - Madrid, Spain, 28041
    - Recruiting
    - University Hospital Ramón y Cajal
  - Málaga, Spain, 29010
    - Recruiting
    - University Hospital Virgen de la Victoria
  - Salamanca, Spain, 37007
    - Recruiting
    - University Clinical Hospital of Salamanca
  - Valencia, Spain, 46010
    - Recruiting
    - University Clinical Hospital of Valencia
  - Valencia, Spain, 46026
    - Recruiting
    - University and Polytechnic Hospital La Fe
  - Zaragoza, Spain, 50006
    - Recruiting
    - Quironsalud Zaragoza Hospital
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Recruiting
    - Birmingham Heartlands Hospital
  - Boston, United Kingdom, PE21 9QS
    - Recruiting
    - Pilgrim Hospital
  - Boston, United Kingdom, Lincoln County Hospital
    - Recruiting
    - Lincoln County Hospital
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Addenbrooke's Hospital
  - Cardiff, United Kingdom, CF14 4XW
    - Recruiting
    - University Hospital of Wales
  - Edinburgh, United Kingdom, EH4 2XU
    - Recruiting
    - Western General Hospital, Lothian Health Board
  - Gloucester, United Kingdom, GL1 3NN
    - Recruiting
    - Gloucestershire Royal Hospital
  - Harrogate, United Kingdom, HG2 7SX
    - Recruiting
    - Harrogate District Hospital
  - Leicester, United Kingdom, LE1 5WW
    - Recruiting
    - Leicester Royal Infirmary
  - Liverpool, United Kingdom, L7 8YA
    - Recruiting
    - The Clatterbridge Cancer Center NHS Foundation Trust
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's Hospital
  - London, United Kingdom, NW1 2PG
    - Recruiting
    - University College Hospital
  - Oxford, United Kingdom, OX4 6LB
    - Recruiting
    - Genesis Care, Oxford
  - Windsor, United Kingdom, SL4 3HD
    - Recruiting
    - Genesis Care, Windsor
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - UAB Hospital
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Banner MD Anderson Cancer Center
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic - Phoenix
- California
  - La Jolla, California, United States, 92037
    - Recruiting
    - UC San Diego Moores Cancer Center
  - Los Angeles, California, United States, 90095
    - Recruiting
    - UCLA Hematology/Oncology Clinic - Los Angeles
  - San Diego, California, United States, 92103
    - Recruiting
    - Scripps Health, Prebys Cancer Center
  - Torrance, California, United States, 90502
    - Recruiting
    - The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Recruiting
    - Rocky Mountain Cancer Centers - Aurora
- Delaware
  - Newark, Delaware, United States, 19713
    - Recruiting
    - Medical Oncology Hematology Consultants, PA
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Recruiting
    - MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic - Jacksonville
  - Miami, Florida, United States, 33136
    - Recruiting
    - University of Miami
  - Orlando, Florida, United States, 32803
    - Recruiting
    - AdventHealth Cancer Institute
  - Tampa, Florida, United States, 33612
    - Recruiting
    - Moffitt Cancer Center
- Iowa
  - Des Moines, Iowa, United States, 50314
    - Recruiting
    - Mission Cancer + Blood
- Kansas
  - Westwood, Kansas, United States, 66205
    - Recruiting
    - University of Kansas Cancer Center - Westwood
- Kentucky
  - Louisville, Kentucky, United States, 40207
    - Recruiting
    - Norton Cancer Institute
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Recruiting
    - Mary Bird Perkins Cancer Center
- Maryland
  - Baltimore, Maryland, United States, 21231
    - Recruiting
    - Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - The Center for Cancer and Blood Disorders
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana Farber Cancer Institute
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Hospital
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion
- Nebraska
  - Lincoln, Nebraska, United States, 68506
    - Recruiting
    - Nebraska Hematology - Oncology, P.C.
- Nevada
  - Henderson, Nevada, United States, 86442
    - Recruiting
    - Mohtaseb Cancer Center and Blood Disorders
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Hackensack University Medical Center
- New York
  - Brooklyn, New York, United States, 11212
    - Recruiting
    - Brookdale University Hospital and Medical Center
  - Ithaca, New York, United States, 14850
    - Recruiting
    - Cayuga Cancer Center
  - Lake Success, New York, United States, 11042
    - Recruiting
    - Northwell Health, R.J. Zuckerberg Cancer Center
  - New York, New York, United States, 10029-6574
    - Recruiting
    - Icahn School of Medicine at Mount Sinai
  - The Bronx, New York, United States, 10467
    - Recruiting
    - Montefiore Einstein Comprehensive Cancer Center
- North Carolina
  - Charleston, North Carolina, United States, 29425-8900
    - Recruiting
    - Medical University of South Carolina (MUSC)
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Atrium Health Levine Cancer Institute
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center
  - Wilson, North Carolina, United States, 27893
    - Recruiting
    - Regional Medical Oncology Center
  - Winston-Salem, North Carolina, United States, 27157
    - Recruiting
    - Atrium Health Wake Forest Baptist
- Ohio
  - Canton, Ohio, United States, 44718
    - Recruiting
    - Gabrail Cancer Center
  - Cincinnati, Ohio, United States, 45219
    - Recruiting
    - University of Cincinnati Medical Center
  - Cleveland, Ohio, United States, 44195
    - Recruiting
    - Cleveland Clinic
  - Cleveland, Ohio, United States, 44111
    - Recruiting
    - Cleveland Clinic Cancer Center at Fairview Hospital
  - Independence, Ohio, United States, 44131
    - Recruiting
    - Independence Family Health Center - Cleveland Clinic
  - Mayfield Heights, Ohio, United States, 44124
    - Recruiting
    - Hillcrest Hospital - Cleveland Clinic
- Oregon
  - Eugene, Oregon, United States, 97401
    - Recruiting
    - Willamette Valley Cancer Institute and Research Center
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Recruiting
    - Abramson Cancer Center of The University of Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15224
    - Recruiting
    - West Penn Hospital
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Recruiting
    - Tennessee Oncology
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Tennessee Oncology
- Texas
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UT - SouthWestern
  - Houston, Texas, United States, 77030
    - Recruiting
    - U.T. MD Anderson Cancer Center
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - The University of Texas Health Science Center at San Antonio
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Recruiting
    - University of Utah, Huntsman Cancer Institute
- Virginia
  - Richmond, Virginia, United States, 23229
    - Recruiting
    - Virginia Cancer Institute
  - Richmond, Virginia, United States, 23298
    - Recruiting
    - VCU Medical Center
  - Virginia Beach, Virginia, United States, 23456
    - Recruiting
    - Virginia Oncology Associates - Virginia Beach
- Washington
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Fred Hutchinson Cancer Centre
  - Tacoma, Washington, United States, 98405
    - Recruiting
    - Northwest Medical Specialties, PLLC - Tacoma
- Wisconsin
  - Sheboygan, Wisconsin, United States, 53081
    - Recruiting
    - Sheboygan Cancer & Blood Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.	Drug: Navtemadlin Navtemadlin is an investigational MDM2 inhibitor Other Names: KRT-232 Drug: Ruxolitinib Ruxolitinib is a janus kinase 1/2 inhibitor Other Names: Jakafi Jakavi
Active Comparator: Arm 2 Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.	Drug: Ruxolitinib Ruxolitinib is a janus kinase 1/2 inhibitor Other Names: Jakafi Jakavi Drug: Navtemadlin placebo Navtemadlin placebo Other Names: KRT-232

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2 Time Frame: 24 weeks	The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period	24 weeks
To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2 Time Frame: 24 weeks	The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare time to progression between Arm 1 and Arm 2 Time Frame: Up to 8 years	Time to progression or death from any cause in subjects randomized to each arm	Up to 8 years
To compare overall survival (OS) between Arm 1 and Arm 2 Time Frame: Up to 8 years	Time to death from any cause in subjects randomized to each arm	Up to 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartos Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 21, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

KRT-232-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Primary Myelofibrosis

Clinical Trials on Navtemadlin

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