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

PHASE3RecruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
MyelofibrosisPost-PV MFPost-ET MyelofibrosisPrimary MyelofibrosisMF
Interventions
DRUG

Navtemadlin

Navtemadlin is an investigational MDM2 inhibitor

DRUG

Navtemadlin placebo

Navtemadlin placebo

DRUG

Ruxolitinib

Ruxolitinib is a janus kinase 1/2 inhibitor

Trial Locations (215)

1090

RECRUITING

Medical University Vienna, Vienna

1160

RECRUITING

Hospital Ottakring, Department of Internal Medicine I, Vienna

2030

RECRUITING

Antwerp Hospital Network (ZNA) Cadix, Antwerp

3000

RECRUITING

University Hospitals Leuven, Campus Gasthuisberg, Leuven

4000

RECRUITING

University Hospital Center Sart-Tilman, Liège

4020

RECRUITING

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

4021

RECRUITING

Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology, Linz

4400

RECRUITING

Szabolcs-Szatmar-Bereg County Teaching Hospital, Nyíregyháza

4600

RECRUITING

JSC Vian, Kutaisi

5530

RECRUITING

UCL Mont-Godinne University Hospitals, Yvoir

6000

RECRUITING

Royal Perth Hospital, Perth

6009

RECRUITING

Sir Charles Gairdner Hospital, Nedlands

6020

RECRUITING

Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology), Innsbruck

7000

RECRUITING

Royal Hobart Hospital (RHH), Hobart

7203

RECRUITING

Clinical Hospital Center Bezanijska Kosa, Belgrade

8036

RECRUITING

University Hospital Graz, Department of Internal Medicine, Graz

8700

RECRUITING

Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology, Leoben

8800

RECRUITING

General Hospital Delta, Roeselare

10000

RECRUITING

Clinical Hospital Dubrava, Zagreb

RECRUITING

Clinical Hospital Merkur, Zagreb

RECRUITING

Solmed Clinic, Zagreb

RECRUITING

University Hospital Centre Zagreb, Zagreb

10003

WITHDRAWN

Caceres Hospital Complex - San Pedro de Alcantara General Hospital, Cáceres

10126

RECRUITING

City of Health and Science of Turin, Turin

10467

RECRUITING

Montefiore Einstein Comprehensive Cancer Center, The Bronx

11000

RECRUITING

University Clinical Center of Serbia, Belgrade

11042

RECRUITING

Northwell Health, R.J. Zuckerberg Cancer Center, Lake Success

11212

RECRUITING

Brookdale University Hospital and Medical Center, Brooklyn

12800

RECRUITING

Institute of Hematology and Blood Transfusion, Prague

14850

RECRUITING

Cayuga Cancer Center, Ithaca

15224

RECRUITING

West Penn Hospital, Pittsburgh

19104

RECRUITING

Abramson Cancer Center of the University of Pennsylvania, Philadelphia

19713

RECRUITING

Medical Oncology Hematology Consultants, PA, Newark

20007

RECRUITING

MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington D.C.

20122

RECRUITING

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda, Milan

20246

RECRUITING

University Hospital Hamburg-Eppendorf, Hamburg

20817

RECRUITING

The Center for Cancer and Blood Disorders, Bethesda

21000

RECRUITING

University Hospital of Split, Split

21231

RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

22000

RECRUITING

General Hospital of Sibenik-Knin County, Šibenik

23229

RECRUITING

Virginia Cancer Institute, Richmond

23298

RECRUITING

VCU Medical Center, Richmond

23456

RECRUITING

Virginia Oncology Associates - Virginia Beach, Virginia Beach

24105

RECRUITING

University Hospital Schleswig-Holstein, Kiel

26504

RECRUITING

University General Hospital of Patras, Pátrai

27157

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

27710

RECRUITING

Duke University Medical Center, Durham

27893

RECRUITING

Regional Medical Oncology Center, Wilson

28041

RECRUITING

University Hospital 12 de Octubre, Madrid

RECRUITING

University Hospital Ramon y Cajal, Madrid

28100

RECRUITING

"University Hospital Maggiore della Carita of Novara", Novara

28204

RECRUITING

Atrium Health Levine Cancer Institute, Charlotte

29010

RECRUITING

University Hospital Virgen de la Victoria, Málaga

30900

RECRUITING

Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology, Nîmes

32224

RECRUITING

Mayo Clinic - Jacksonville, Jacksonville

32803

RECRUITING

AdventHealth Cancer Institute, Orlando

33136

RECRUITING

University of Miami, Miami

33612

RECRUITING

Moffitt Cancer Center, Tampa

35010

RECRUITING

Gran Canaria Dr Negrin University Hospital, Las Palmas de Gran Canaria

35233

RECRUITING

UAB Hospital, Birmingham

37000

RECRUITING

Tours Regional University Hospital Center, Tours

37007

RECRUITING

University Clinical Hospital of Salamanca, Salamanca

37203

RECRUITING

Tennessee Oncology, Nashville

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

37404

RECRUITING

Tennessee Oncology, Chattanooga

40138

RECRUITING

Polyclinic S. Orsola-Malpighi, Bologna

40207

RECRUITING

Norton Cancer Institute, Louisville

40479

RECRUITING

Marien Hospital Duesseldorf GmbH, Düsseldorf

41944

RECRUITING

Kyungpook National University Hospital, Daegu

42601

RECRUITING

Keimyung University - Dongsan Medical Center, Daegu

44000

RECRUITING

Nantes University Hospital Center - Hotel Dieu Hospital, Nantes

44111

RECRUITING

Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland

44124

RECRUITING

Hillcrest Hospital - Cleveland Clinic, Mayfield Heights

44131

RECRUITING

Independence Family Health Center - Cleveland Clinic, Independence

44195

RECRUITING

Cleveland Clinic, Cleveland

44718

RECRUITING

Gabrail Cancer Center, Canton

45219

RECRUITING

University of Cincinnati Medical Center, Cincinnati

46010

RECRUITING

University Clinical Hospital of Valencia, Valencia

46026

RECRUITING

University and Polytechnic Hospital La Fe, Valencia

47014

RECRUITING

"Institute of Romagna for Cancer Research Dino Amadori - IRCCS IRST", Forlì

47392

RECRUITING

Inje University Busan Paik Hospital, Busan

48109

RECRUITING

University of Michigan Hospital, Ann Arbor

48202

RECRUITING

Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion, Detroit

49241

RECRUITING

Pusan National University Hospital, Busan

50006

RECRUITING

Quironsalud Zaragoza Hospital, Zaragoza

50134

RECRUITING

Careggi University Hospital, Florence

50314

RECRUITING

Mission Cancer + Blood, Des Moines

53081

RECRUITING

Sheboygan Cancer & Blood Specialists, Sheboygan

59037

RECRUITING

Amiens Picardie University Hospital - South, Amiens

RECRUITING

Lille Regional University Hospital Center, Lille

60126

RECRUITING

Marche University Hospital, Ancona

61121

RECRUITING

Local Health Company of Pesaro and Urbino, Pesaro

66205

RECRUITING

University of Kansas Cancer Center - Westwood, Westwood

67200

RECRUITING

Strasbourg Europe Institut of Cancerology, Strasbourg

68506

RECRUITING

Nebraska Hematology - Oncology, P.C., Lincoln

69120

RECRUITING

University Hospital Heidelberg, Heidelberg

69310

RECRUITING

South Lyon Hospital Center, Lyon

70376

RECRUITING

Robert-Bosch-Hospital, Stuttgart

70809

RECRUITING

Mary Bird Perkins Cancer Center, Baton Rouge

73557

RECRUITING

Staufer Schwaebisch Gmuend Hospital, Mutlangen

75010

RECRUITING

Saint-Louis Hospital, Department of Adult Hematology, Paris

75390

RECRUITING

UT - SouthWestern, Dallas

77030

RECRUITING

U.T. MD Anderson Cancer Center, Houston

78229

RECRUITING

The University of Texas Health Science Center at San Antonio, San Antonio

79106

RECRUITING

University Hospital Freiburg, Freiburg im Breisgau

80012

RECRUITING

Rocky Mountain Cancer Centers - Aurora, Aurora

81675

RECRUITING

Hospital Rechts der Isar, Munich

84112

RECRUITING

University of Utah, Huntsman Cancer Institute, Salt Lake City

85054

RECRUITING

Mayo Clinic - Phoenix, Phoenix

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

86442

RECRUITING

Mohtaseb Cancer Center and Blood Disorders, Henderson

89081

RECRUITING

University Hospital Ulm, Ulm

90095

RECRUITING

UCLA Hematology/Oncology Clinic - Los Angeles, Los Angeles

90419

RECRUITING

Hospital Nuernberg, Campus North, Nuremberg

90502

RECRUITING

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92037

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

92103

RECRUITING

Scripps Health, Prebys Cancer Center, San Diego

97401

RECRUITING

Willamette Valley Cancer Institute and Research Center, Eugene

98109

RECRUITING

Fred Hutchinson Cancer Centre, Seattle

98405

RECRUITING

Northwest Medical Specialties, PLLC - Tacoma, Tacoma

400015

RECRUITING

"Prof. Dr. Ion Chiricuta Institute of Oncology, Hematology Department", Cluj-Napoca

410469

RECRUITING

Bihor County Emergency Clinical Hospital, Department of Hematology, Oradea

500052

RECRUITING

Onco Card Srl, Brasov

540136

RECRUITING

Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit, Târgu Mureş

02215

RECRUITING

Dana Farber Cancer Institute, Boston

07601

RECRUITING

Hackensack University Medical Center, Hackensack

10029-6574

RECRUITING

ICAHN School of Medicine at Mount Sinai, New York

29425-8900

RECRUITING

Medical University of South Carolina (MUSC), Charleston

SA 5000

RECRUITING

Royal Adelaide Hospital, Adelaide

VIC 3168

RECRUITING

Monash Medical Center Clayton, Clayton

QLD 4814

RECRUITING

Townsville University Hospital, Douglas

NSW 2250

RECRUITING

Gosford Hospital, Gosford

NSW 2217

RECRUITING

St George Hospital, Kogarah

VIC 3000

RECRUITING

The Royal Melbourne Hospital - Peter MacCallum Cancer Center, Melbourne

VIC 3004

RECRUITING

The Alfred Hospital, Melbourne

NSW 2298

RECRUITING

Calvary Mater Newcastle Hospital, Waratah

51 000

RECRUITING

Clinical Hospital Centre Rijeka, Rijeka

625 00

RECRUITING

University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology, Brno

500 05

RECRUITING

University Hospital Hradec Kralove, Hradec Králové

708 52

RECRUITING

University Hospital Ostrava, Ostrava

100 00

RECRUITING

University Hospital Kralovske Vinohrady, Prague

Unknown

RECRUITING

Angers University Hospital Center, Angers

RECRUITING

Leon Berard Center, Lyon

RECRUITING

Bordeaux University Hospital, Pessac

RECRUITING

University Hospital Center of Poitiers, Poitiers

RECRUITING

University Hospital of Toulouse, IUCT-Oncopole, Toulouse

RECRUITING

Hannover Medical School, Hanover

RECRUITING

University General Hospital of Ioannina, Ioannina

RECRUITING

Fejer County St. Gyorgy University Teaching Hospital, Székesfehérvár

RECRUITING

National Hospital SS. Antonio e Biagio e Cesare Arrigo, Alessandria

RECRUITING

ASST Spedali Civili Brescia, Brescia

RECRUITING

"University Hospital G.Rodolico - San Marco", Catania

RECRUITING

European Institute of Oncology (IEO), IRCCS, Milan

RECRUITING

University Hospital San Luigi Gonzaga, Orbassano

RECRUITING

"University Polyclinic Hospital Paolo Giaccone Palermo", Palermo

RECRUITING

Polyclinic San Matteo, IRCCS, Pavia

RECRUITING

Hospital Arcispedale S. Maria Nuova of Reggio Emilia, Reggio Emilia

RECRUITING

Hospital S. Eugenio- Rome 2 ASL, Rome

RECRUITING

ASST Sette Laghi Hospital, Varese

RECRUITING

"InterHem General Partnership", Bialystok

RECRUITING

University Teaching Centre, Hematology and Transplantology Clinic, Gdansk

RECRUITING

Independent Public Healthcare Facility University Hospital in Krakow, Krakow

RECRUITING

Oncology Center of Warmia and Mazury in Olsztyn, Olsztyn

RECRUITING

Dr Alfred Sokolowski Specialty Hospital, Wałbrzych

RECRUITING

Jan Mikulicz-Radecki Teaching Hospital in Wroclaw, Wroclaw

RECRUITING

Braga Hospital, Braga

RECRUITING

Vila Nova de Gaia Central Hospital, Vila Nova de Gaia

RECRUITING

Clinical Center of Vojvodina, Novi Sad

RECRUITING

Catalan Institute of Oncology, Hospital Duran i Reynals, Barcelona

06200

RECRUITING

Archet 1 and 2 hospital, Nice

0119

RECRUITING

JSC German Hospital, Tbilisi

0141

RECRUITING

LEPL The First University Clinic of Tbilisi State Medical University, Tbilisi

0144

RECRUITING

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC, Tbilisi

0159

RECRUITING

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

0186

RECRUITING

Caucasus Medical Centre LLC, Tbilisi

06120

RECRUITING

University Hospital Halle (Saale), Halle

07747

RECRUITING

University Hospital Jena, Jena

04103

RECRUITING

MVZ Mitte Am Johannisplatz, Leipzig

115 27

RECRUITING

General Hospital of Athens Laikon, Athens

PC 12462

RECRUITING

"University General Hospital Attikon", Athens

PC 57010

RECRUITING

"General Hospital of Thessaloniki G. Papanikolaou", Thessaloniki

H-1088

RECRUITING

Semmelweis University, Budapest

H-7100

RECRUITING

Tolna County Hospital, Szekszárd

93-513

RECRUITING

Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center, Lodz

33 - 300

RECRUITING

Jedrzej Sniadecki Specialist Hospital in Nowy Sacz, Nowy Sącz

60-185

RECRUITING

AIDPORT, Poznan

70-784

RECRUITING

Dom Lekarski Medical Center Outlet Park, Szczecin

76-200

RECRUITING

Janusz Korczak Provincial Specialist Hospital, Słupsk

00-710

RECRUITING

Clinical Best Solutions LLC, Limited Partnership, Warsaw

3810- 501

RECRUITING

Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro, Aveiro

1449-005

RECRUITING

Central Hospital of Western Lisbon, Lisbon

1649-035

RECRUITING

Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria, Lisbon

020125

RECRUITING

Colentina Clinical Hospital, Department of Hematology, Bucharest

34 000

RECRUITING

University Clinical Center Kragujevac, Kragujevac

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

04401

RECRUITING

Soon Chun Hyang University Hospital Seoul, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06591

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

08916

RECRUITING

University Hospital Germans Trias i Pujol, Badalona

08035

RECRUITING

University Hospital Vall d'Hebron, Barcelona

B9 5SS

RECRUITING

Birmingham Heartlands Hospital, Birmingham

Lincoln County Hospital

RECRUITING

Lincoln County Hospital, Boston

PE21 9QS

RECRUITING

Pilgrim Hospital, Boston

CB2 0QQ

RECRUITING

Addenbrooke's Hospital, Cambridge

CF14 4XW

RECRUITING

University Hospital of Wales, Cardiff

EH4 2XU

RECRUITING

Western General Hospital, Lothian Health Board, Edinburgh

GL1 3NN

RECRUITING

Gloucestershire Royal Hospital, Gloucester

HG2 7SX

RECRUITING

Harrogate District Hospital, Harrogate

LE1 5WW

RECRUITING

Leicester Royal Infirmary, Leicester

L7 8YA

RECRUITING

The Clatterbridge Cancer Center NHS Foundation Trust, Liverpool

NW1 2PG

RECRUITING

University College Hospital, London

SE1 9RT

RECRUITING

Guy's Hospital, London

OX4 6LB

RECRUITING

Genesis Care, Oxford, Oxford

SL4 3HD

RECRUITING

Genesis Care, Windsor, Windsor

Sponsors
All Listed Sponsors
lead

Kartos Therapeutics, Inc.

INDUSTRY

NCT06479135 - Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib | Biotech Hunter | Biotech Hunter