A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
Start Date
3/4/2021
Completion Date
9/1/2027
Summary
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received at least 2 prior lines of systemic therapy.
Detailed Description
AGAVE-201 is a Phase 2, open-label, randomized, multicenter study to evaluate the efficacy, safety, and tolerability of axatilimab in participants with recurrent or refractory active cGVHD after failure of at least 2 prior lines of systemic therapy due to progression of disease, intolerability, or toxicity. Participants will be randomized to receive 1 of 3 different axatilimab treatment regimens in 28-day treatment cycles for up to 2 years.
Eligibility Criteria
Age Range: 2 years to No maximum
Interventions
Axatilimab
Conditions
Locations
University of Alabama at Birmingham - Children's of Alabama
Birmingham, Alabama 35233
United States
University of Alabama at Birmingham
Birmingham, Alabama 35294
United States
City of Hope
Duarte, California 91010
United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California 90059
United States
Stanford Cancer Center
Stanford, California 94305
United States
Children's National Medical Center
Washington D.C., District of Columbia 20010
United States
University of Florida (UF)
Gainesville, Florida 32610
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United States
University of Miami
Miami, Florida 33136
United States
AdventHealth Orlando
Orlando, Florida 32806
United States
Moffitt
Tampa, Florida 33612
United States
Emory University
Atlanta, Georgia 30322
United States
Northside Hospital
Atlanta, Georgia 30342
United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois 60637
United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
United States
Tulane University Medical Center
New Orleans, Louisiana 70112
United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland 21231-2410
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States
University of Michigan
Ann Arbor, Michigan 48084
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
Weill Medical College of Cornell University
New York, New York 10022
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Wake Forest
Winston-Salem, North Carolina 27157
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
The Cleveland Clinic Foundation
Lyndhurst, Ohio 44195
United States
University of Oklahoma - Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Intermountain Healthcare
Salt Lake City, Utah 84111
United States
University of Utah
Salt Lake City, Utah 84112
United States
University of Virginia Medical Center
Charlottesville, Virginia 22908
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington 98109
United States
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin 53792
United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
The Royal Children's Hospital
Parkville, Victoria 3052
Australia
Westmead Hospital
Westmead,
Australia
Universitaire Ziekenhuizen Leuven
Leuven,
Belgium
AZ Delta
Roeselare,
Belgium
Vancouver Coastal Health Authority
Vancouver, British Columbia V5Z 1M9
Canada
Princess Margaret Hospital
Toronto, Ontario
Canada
McGill University Health Center - Research Institute
Montreal, Quebec H3G 1A4
Canada
CHU Sainte-Justine
Montreal, Quebec H3T 1C5
Canada
CHU de Grenoble
La Tronche, Auvergne-Rhône-Alpes 38700
France
Institut de cancérologie Strasbourg Europe (ICANS)
Strasbourg, Grand Est 67200
France
IUCT-Oncopole
Toulouse, Haure-Garrone 31100
France
CHU Amiens Picardie - Hopital Sud
Amiens, Hauts-de-France 80054
France
CHRU de Lille - Hopital Claude Huriez
Lille, Hauts-de-France 59037
France
CHRU de Nancy - Hôpitaux de Brabois
Nancy,
France
CHU de Nantes - Hôtel-Dieu
Nantes,
France
Hopital Saint Louis
Paris, 75010
France
Hopital Pitie Salpetriere
Paris, 75013
France
CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
Pessac,
France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite,
France
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitaetsklinikum Jena
Jena, 07740
Germany
Universitaetsklinikum Leipzig
Leipzig, 04103
Germany
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, 55131
Germany
Universitaetsklinikum Muenster
Münster, 48149
Germany
Universitatsklinikum Regensburg
Regensburg, 93053
Germany
General Hospital of Thessaloniki G. Papanikolaou - Hematology Department, BMT Unit
Eksochi, Thessaloniki 57010
Greece
University Hospital of West Attica - Attikon - Hematology Division
Athens,
Greece
University General Hospital of Patras
Pátrai, 26500
Greece
Rambam Health Care Campus
Haifa, 3109601
Israel
Hadassah Medical Center Ein Karem
Jerusalem, 9112001
Israel
Chaim Sheba Medical Center
Ramat Gan, 5262160
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Israel
ASST degli Spedali Civili di Brescia
Brescia,
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
Italy
IRCCS Ospedale San Raffaele
Milan, 20132
Italy
ASST di Monza-Ospedale San Gerardo
Monza,
Italy
Fondazione Monza e Brianza per il Bambino e la sua Mamma
Monza,
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia,
Italy
Fondazione Policlinica Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Roma, 168
Italy
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
Torino,
Italy
Citta della Salute e della Scienza di Torino - Ospedale le Molinette
Torino,
Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach - Klinika Transplantacji Szpiku i Onkohematologii
Gliwice, 44-102
Poland
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. (IPO-Lisboa)
Lisbon, 1099-023
Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto,
Portugal
National University Hospital
Singapore, 119074
Singapore
KK Women's and Children hospital
Singapore, 229899
Singapore
Singapore General Hospital
Singapore,
Singapore
Pusan National University Hospital
Busan,
South Korea
Korea University Anam Hospital
Seoul,
South Korea
Seoul National University Hospital
Seoul,
South Korea
Severance Hospital
Seoul,
South Korea
Hospital Universitario Virgen del Rocio
Seville, Seville 41013
Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Spain
Hospital Clinic Barcelona
Barcelona, 8032
Spain
Hospital Universitario Donostia
Donostia / San Sebastian,
Spain
Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves
Granada, 18014
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Puerta de Hierro
Majadahonda,
Spain
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
Spain
Hospital Universitario Marquis de Valdecilla
Santander,
Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taiwan
China Medical University Hospital
Taichung, 40447
Taiwan
National Taiwan University Hospital
Taipei, 100
Taiwan
Bristol Royal Hospital for Children
Bristol, BS2 8BJ
United Kingdom
University Hospital of Wales
Cardiff,
United Kingdom
Queen Elizabeth University Hospital
Glasgow,
United Kingdom
Hammersmith Hospital
London,
United Kingdom
King's College Hospital NHS Foundation Trust
London,
United Kingdom
Royal Marsden Foundation Trust
London,
United Kingdom