Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Start Date
6/3/2024
Completion Date
12/31/2028
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Navtemadlin
Navtemadlin placebo
Ruxolitinib
Conditions
Locations
UAB Hospital
Birmingham, Alabama 35233
United States
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Mayo Clinic - Phoenix
Phoenix, Arizona 85054
United States
UC San Diego Moores Cancer Center
La Jolla, California 92037
United States
UCLA Hematology/Oncology Clinic - Los Angeles
Los Angeles, California 90095
United States
Scripps Health, Prebys Cancer Center
San Diego, California 92103
United States
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United States
Rocky Mountain Cancer Centers - Aurora
Aurora, Colorado 80012
United States
Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
United States
MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia 20007
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
University of Miami
Miami, Florida 33136
United States
AdventHealth Cancer Institute
Orlando, Florida 32803
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Mission Cancer + Blood
Des Moines, Iowa 50314
United States
University of Kansas Cancer Center - Westwood
Westwood, Kansas 66205
United States
Norton Cancer Institute
Louisville, Kentucky 40207
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana 70809
United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21231
United States
The Center for Cancer and Blood Disorders
Bethesda, Maryland 20817
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Michigan Hospital
Ann Arbor, Michigan 48109
United States
Henry Ford Cancer Institute - Brigitte Harris Cancer Pavilion
Detroit, Michigan 48202
United States
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska 68506
United States
Mohtaseb Cancer Center and Blood Disorders
Henderson, Nevada 86442
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Brookdale University Hospital and Medical Center
Brooklyn, New York 11212
United States
Cayuga Cancer Center
Ithaca, New York 14850
United States
Northwell Health, R.J. Zuckerberg Cancer Center
Lake Success, New York 11042
United States
ICAHN School of Medicine at Mount Sinai
New York, New York 10029-6574
United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York 10467
United States
Medical University of South Carolina (MUSC)
Charleston, North Carolina 29425-8900
United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Regional Medical Oncology Center
Wilson, North Carolina 27893
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
Gabrail Cancer Center
Canton, Ohio 44718
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio 44111
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Independence Family Health Center - Cleveland Clinic
Independence, Ohio 44131
United States
Hillcrest Hospital - Cleveland Clinic
Mayfield Heights, Ohio 44124
United States
Willamette Valley Cancer Institute and Research Center
Eugene, Oregon 97401
United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Tennessee Oncology
Chattanooga, Tennessee 37404
United States
Tennessee Oncology
Nashville, Tennessee 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
UT - SouthWestern
Dallas, Texas 75390
United States
U.T. MD Anderson Cancer Center
Houston, Texas 77030
United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Virginia Cancer Institute
Richmond, Virginia 23229
United States
VCU Medical Center
Richmond, Virginia 23298
United States
Virginia Oncology Associates - Virginia Beach
Virginia Beach, Virginia 23456
United States
Fred Hutchinson Cancer Centre
Seattle, Washington 98109
United States
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington 98405
United States
Sheboygan Cancer & Blood Specialists
Sheboygan, Wisconsin 53081
United States
Royal Hobart Hospital (RHH)
Hobart, Tasmania 7000
Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
Australia
Royal Adelaide Hospital
Adelaide, SA 5000
Australia
Monash Medical Center Clayton
Clayton, VIC 3168
Australia
Townsville University Hospital
Douglas, QLD 4814
Australia
Gosford Hospital
Gosford, NSW 2250
Australia
St George Hospital
Kogarah, NSW 2217
Australia
The Royal Melbourne Hospital - Peter MacCallum Cancer Center
Melbourne, VIC 3000
Australia
The Alfred Hospital
Melbourne, VIC 3004
Australia
Royal Perth Hospital
Perth, 6000
Australia
Calvary Mater Newcastle Hospital
Waratah, NSW 2298
Australia
University Hospital Graz, Department of Internal Medicine
Graz, 8036
Austria
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck, 6020
Austria
Regional Hospital Hochsteiermark - Leoben, Department of Internal Medicine, Department of Hematology and Oncology
Leoben, 8700
Austria
Ordensklinikum Linz GmbH Elisabethinen Hospital, Department of Internal Medicine I - Hemato-Oncology
Linz, 4020
Austria
Kepler University Hospital GmbH, Med Campus 3, University Clinic for Hematology and Internal Oncology
Linz, 4021
Austria
Medical University Vienna
Vienna, 1090
Austria
Hospital Ottakring, Department of Internal Medicine I
Vienna, 1160
Austria
Antwerp Hospital Network (ZNA) Cadix
Antwerp, 2030
Belgium
University Hospitals Leuven, Campus Gasthuisberg
Leuven, 3000
Belgium
University Hospital Center Sart-Tilman
Liège, 4000
Belgium
General Hospital Delta
Roeselare, 8800
Belgium
UCL Mont-Godinne University Hospitals
Yvoir, 5530
Belgium
Clinical Hospital Centre Rijeka
Rijeka, 51 000
Croatia
University Hospital of Split
Split, 21000
Croatia
General Hospital of Sibenik-Knin County
Šibenik, 22000
Croatia
Clinical Hospital Dubrava
Zagreb, 10000
Croatia
Clinical Hospital Merkur
Zagreb, 10000
Croatia
Solmed Clinic
Zagreb, 10000
Croatia
University Hospital Centre Zagreb
Zagreb, 10000
Croatia
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
Brno, 625 00
Czechia
University Hospital Hradec Kralove
Hradec Králové, 500 05
Czechia
University Hospital Ostrava
Ostrava, 708 52
Czechia
University Hospital Kralovske Vinohrady
Prague, 100 00
Czechia
Institute of Hematology and Blood Transfusion
Prague, 12800
Czechia
Saint-Louis Hospital, Department of Adult Hematology
Paris, Paris 75010
France
Amiens Picardie University Hospital - South
Amiens, 59037
France
Angers University Hospital Center
Angers,
France
Lille Regional University Hospital Center
Lille, 59037
France
South Lyon Hospital Center
Lyon, 69310
France
Leon Berard Center
Lyon,
France
Nantes University Hospital Center - Hotel Dieu Hospital
Nantes, 44000
France
Archet 1 and 2 hospital
Nice, 06200
France
Nimes University Hospital Center, Department of Clinical Hematology and Medical Oncology
Nîmes, 30900
France
Bordeaux University Hospital
Pessac,
France
University Hospital Center of Poitiers
Poitiers,
France
Strasbourg Europe Institut of Cancerology
Strasbourg, 67200
France
University Hospital of Toulouse, IUCT-Oncopole
Toulouse,
France
Tours Regional University Hospital Center
Tours, 37000
France
JSC Vian
Kutaisi, 4600
Georgia
JSC German Hospital
Tbilisi, 0119
Georgia
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi, 0141
Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, 0144
Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 0159
Georgia
Caucasus Medical Centre LLC
Tbilisi, 0186
Georgia
Marien Hospital Duesseldorf GmbH
Düsseldorf, 40479
Germany
University Hospital Freiburg
Freiburg im Breisgau, 79106
Germany
University Hospital Halle (Saale)
Halle, 06120
Germany
University Hospital Hamburg-Eppendorf
Hamburg, 20246
Germany
Hannover Medical School
Hanover,
Germany
University Hospital Heidelberg
Heidelberg, 69120
Germany
University Hospital Jena
Jena, 07747
Germany
University Hospital Schleswig-Holstein
Kiel, 24105
Germany
MVZ Mitte Am Johannisplatz
Leipzig, 04103
Germany
Hospital Rechts der Isar
Munich, 81675
Germany
Staufer Schwaebisch Gmuend Hospital
Mutlangen, 73557
Germany
Hospital Nuernberg, Campus North
Nuremberg, 90419
Germany
Robert-Bosch-Hospital
Stuttgart, 70376
Germany
University Hospital Ulm
Ulm, 89081
Germany
General Hospital of Athens Laikon
Athens, 115 27
Greece
University General Hospital "Attikon"
Athens, PC 12462
Greece
University General Hospital of Ioannina
Ioannina,
Greece
University General Hospital of Patras
Pátrai, 26504
Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, PC 57010
Greece
Semmelweis University
Budapest, H-1088
Hungary
Szabolcs-Szatmar-Bereg County Teaching Hospital
Nyíregyháza, 4400
Hungary
Tolna County Hospital
Szekszárd, H-7100
Hungary
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár,
Hungary
National Hospital SS. Antonio e Biagio e Cesare Arrigo
Alessandria,
Italy
Marche University Hospital
Ancona, 60126
Italy
Polyclinic S. Orsola-Malpighi
Bologna, 40138
Italy
ASST Spedali Civili Brescia
Brescia,
Italy
University Hospital "G.Rodolico - San Marco"
Catania,
Italy
Careggi University Hospital
Florence, 50134
Italy
Institute of Romagna for Cancer Research " Dino Amadori" - IRCCS IRST
Forlì, 47014
Italy
Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda
Milan, 20122
Italy
European Institute of Oncology (IEO), IRCCS
Milan,
Italy
University Hospital "Maggiore della Carita" of Novara
Novara, 28100
Italy
University Hospital San Luigi Gonzaga
Orbassano,
Italy
University Polyclinic Hospital "Paolo Giaccone" Palermo
Palermo,
Italy
Polyclinic San Matteo, IRCCS
Pavia,
Italy
Local Health Company of Pesaro and Urbino
Pesaro, 61121
Italy
Hospital Arcispedale S. Maria Nuova of Reggio Emilia
Reggio Emilia,
Italy
Hospital S. Eugenio- Rome 2 ASL
Rome,
Italy
City of Health and Science of Turin
Turin, 10126
Italy
ASST Sette Laghi Hospital
Varese,
Italy
"InterHem" General Partnership
Bialystok,
Poland
University Teaching Centre, Hematology and Transplantology Clinic
Gdansk,
Poland
Independent Public Healthcare Facility University Hospital in Krakow
Krakow,
Poland
Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center
Lodz, 93-513
Poland
Jedrzej Sniadecki Specialist Hospital in Nowy Sacz
Nowy Sącz, 33 - 300
Poland
Oncology Center of Warmia and Mazury in Olsztyn
Olsztyn,
Poland
AIDPORT
Poznan, 60-185
Poland
Dom Lekarski Medical Center Outlet Park
Szczecin, 70-784
Poland
Janusz Korczak Provincial Specialist Hospital
Słupsk, 76-200
Poland
Clinical Best Solutions LLC, Limited Partnership
Warsaw, 00-710
Poland
Dr Alfred Sokolowski Specialty Hospital
Wałbrzych,
Poland
Jan Mikulicz-Radecki Teaching Hospital in Wroclaw
Wroclaw,
Poland
Hospital Center of Baixo Vouga -Aveiro Unit - Hospital Infante D. Pedro
Aveiro, 3810- 501
Portugal
Braga Hospital
Braga,
Portugal
Central Hospital of Western Lisbon
Lisbon, 1449-005
Portugal
Centro Hospitalar Lisboa Norte (CHLN) EPE - Hospital de Santa Maria
Lisbon, 1649-035
Portugal
Vila Nova de Gaia Central Hospital
Vila Nova de Gaia,
Portugal
Onco Card Srl
Brasov, 500052
Romania
Colentina Clinical Hospital, Department of Hematology
Bucharest, 020125
Romania
"Prof. Dr. Ion Chiricuta" Institute of Oncology, Hematology Department
Cluj-Napoca, 400015
Romania
Bihor County Emergency Clinical Hospital, Department of Hematology
Oradea, 410469
Romania
Targu Mures County Emergency Clinical Hospital, Internal Medicine Department I, Hematology Unit
Târgu Mureş, 540136
Romania
University Clinical Center of Serbia
Belgrade, 11000
Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 7203
Serbia
University Clinical Center Kragujevac
Kragujevac, 34 000
Serbia
Clinical Center of Vojvodina
Novi Sad,
Serbia
Inje University Busan Paik Hospital
Busan, 47392
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Kyungpook National University Hospital
Daegu, 41944
South Korea
Keimyung University - Dongsan Medical Center
Daegu, 42601
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, 04401
South Korea
Asan Medical Center
Seoul, 05505
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
South Korea
University Hospital Germans Trias i Pujol
Badalona, 08916
Spain
University Hospital Vall d'Hebron
Barcelona, 08035
Spain
Catalan Institute of Oncology, Hospital Duran i Reynals
Barcelona,
Spain
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, 10003
Spain
Gran Canaria Dr Negrin University Hospital
Las Palmas de Gran Canaria, 35010
Spain
University Hospital 12 de Octubre
Madrid, 28041
Spain
University Hospital Ramon y Cajal
Madrid, 28041
Spain
University Hospital Virgen de la Victoria
Málaga, 29010
Spain
University Clinical Hospital of Salamanca
Salamanca, 37007
Spain
University Clinical Hospital of Valencia
Valencia, 46010
Spain
University and Polytechnic Hospital La Fe
Valencia, 46026
Spain
Quironsalud Zaragoza Hospital
Zaragoza, 50006
Spain
Birmingham Heartlands Hospital
Birmingham, B9 5SS
United Kingdom
Lincoln County Hospital
Boston, Lincoln County Hospital
United Kingdom
Pilgrim Hospital
Boston, PE21 9QS
United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ
United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW
United Kingdom
Western General Hospital, Lothian Health Board
Edinburgh, EH4 2XU
United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
United Kingdom
Harrogate District Hospital
Harrogate, HG2 7SX
United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW
United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust
Liverpool, L7 8YA
United Kingdom
University College Hospital
London, NW1 2PG
United Kingdom
Guy's Hospital
London, SE1 9RT
United Kingdom
Genesis Care, Oxford
Oxford, OX4 6LB
United Kingdom
Genesis Care, Windsor
Windsor, SL4 3HD
United Kingdom