A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
NCT ID: NCT05263999
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
158 participants
INTERVENTIONAL
2022-04-29
2025-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Itolizumab (EQ001)
Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses.
Itolizumab
Itolizumab \[Bmab600\]
EQ001 Placebo
EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
EQ001 Placebo
EQ001 Placebo
Interventions
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Itolizumab
Itolizumab \[Bmab600\]
EQ001 Placebo
EQ001 Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is age ≥12 years and \>40kg at informed consent/assent.
3. Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
4. Has evidence of myeloid engraftment
5. Has a clinical diagnosis of aGVHD Grades III-IV or Grade II with LGI involvement based on Mount Sinai Acute GVHD International Consortium (MAGIC) grading criteria.
6. Began systemic corticosteroid treatment for aGVHD ≤72 hours prior to the start of study drug dosing AND must receive 2 mg/kg/day methylprednisolone or equivalent on Day 1.
Exclusion Criteria
2. An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
3. Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
4. Evidence of cGVHD or overlap syndrome
5. Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
6. Use of any systemic corticosteroids of \>0.5 mg/kg/day methylprednisolone or equivalent for any indication other than aGVHD within 7 days before the onset of aGVHD.
12 Years
ALL
No
Sponsors
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Biocon Limited
INDUSTRY
Equillium
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Development Officer
Role: STUDY_DIRECTOR
Equillium, Inc.
Locations
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Princess Margaret Hospital
Toronto, Ontario, Canada
Institut Paoli Calmettes - Hematology
Marseille, , France
CHU Nice, Hospital l'Archet
Nice, , France
AP-HP Hopital Saint-Louis
Paris, , France
McGill University Health Center - Research Institute
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
CHU Amiens Picardie - Hopital Sud
Amiens, , France
CHU de Caen - Hopital Femme-Enfant-Hematologie (FEH)
Caen, , France
CHU de Grenoble Hôpital Michallon
Grenoble, , France
CHU de Lille - Hopital Claude Huriez
Lille, , France
CHU de Nantes - Hôtel-Dieu
Lyon, , France
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope
Duarte, California, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Chicago Medical Center (UCMC)
Chicago, Illinois, United States
Loyola University Chicago, performing research at Loyola University Medical Center
Maywood, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tulane University Medical Center
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
John Theurer Cancer Center At Hackensack UMC
Hackensack, New Jersey, United States
Rutgers Cancer Institute of NJ
New Brunswick, New Jersey, United States
Northwell Health
Lake Success, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States
Wake Forest
Winston-Salem, North Carolina, United States
Oncology Hematology in Cincinnati
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, LLC (SCRI)
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Royal Adelaide Hospital
Adelaide, , Australia
Royal Melbourne Hospital
East Melbourne, , Australia
Austin Health
Heidelberg, , Australia
Westmead Hospital
Westmead, , Australia
ULB - Institut Jules Bordet; department of Hematology
Anderlecht, , Belgium
ZNA Stuivenberg
Antwerp, , Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, , Belgium
Cliniques Universitaires Saint-Luc; Hematology Department
Brussels, , Belgium
UZ Leuven - Campus Gasthuisberg - Department of Hematology
Leuven, , Belgium
CHU de Liege - Hematology Department
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
Vancouver Coastal Health Authority
Vancouver, British Columbia, Canada
CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
Pessac, , France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Rennes Hôpital Pontchaillou
Rennes, , France
CHU Toulouse, Hematology
Toulouse, , France
Institut Gustave Roussy - Hematology
Villejuif, , France
Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum
Berlin, , Germany
Universitaetsklinikum Koeln (AoeR)
Cologne, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Martin Luther Universitat Halle-Wittenberg
Halle, , Germany
Universitätsklinikum Jena
Jena, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Universitätsklinikum Würzburg, Medizinische Klinik II
Würzburg, , Germany
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center Ein Karem
Jerusalem, , Israel
Bone Marrow Transplantation Unit Rabin MC
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Dipartimento Malattie oncologiche ed ematologiche - U.O. Ematologia - Programma dipartimentale Terapie cellulari avanzate
Bologna, BO, Italy
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco- Presidio Ospedaliero Ferrarotto Alessi
Catania, , Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, , Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
AOU Citta della Salute e della Scienza di Torino - Ospedale Regina Margherita
Torino, , Italy
Azienda Ospedaliera - Universitaria Integrata di Verona - Ospedale Borgo Roma
Verona, , Italy
Starship Children's Hospital
Auckland, , New Zealand
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, , Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, , Portugal
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Donostia
Donostia / San Sebastian, Gipuzkoa, Spain
Hospital Clinic Barcelona
Barcelona, , Spain
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Clinica Universidad de Navarra - Pamplona
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Marques de Valdecilla
Madrid, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Countries
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Related Links
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Company website
Other Identifiers
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EQ-100-02
Identifier Type: -
Identifier Source: org_study_id
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