A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)
- Conditions
- GVHDGraft Versus Host DiseaseAcute-graft-versus-host DiseaseAcute GVHDaGVHD
- Interventions
- Drug: EQ001 Placebo
- Registration Number
- NCT05263999
- Lead Sponsor
- Equillium
- Brief Summary
This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids
- Detailed Description
This study will enroll 200 subjects at approximately 125 sites globally. Subjects will be randomized in a 1:1 ratio to active or placebo and will receive a total of 7 doses administered intravenously approximately every 2 weeks. The study follows the patients for a total of approximately 365 days.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Is willing and able to provide written informed consent/assent and to comply with all protocol procedures and assessments required for the study.
- Is age ≥12 years and >40kg at informed consent/assent.
- Has had an initial allogeneic HSCT for any indication using any graft source, donor source, conditioning regimen intensity or prophylaxis.
- Has evidence of myeloid engraftment
- 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.
- 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.
- Evidence of morphological relapsed, progressive, persistent, or untreated malignancy, with the exception of nonmelanoma skin cancer and in situ ductal carcinoma of the breast.
- An unplanned donor lymphocyte infusion for persistent or recurrent malignancy after HSCT.
- Evidence of persistent molecular disease requiring treatment that was not specified prior to HSCT.
- Evidence of cGVHD or overlap syndrome
- Use of immunosuppressants other than corticosteroids for the treatment of aGVHD.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Itolizumab (EQ001) Itolizumab Itolizumab (EQ001) administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses. EQ001 Placebo EQ001 Placebo EQ001 Placebo administered in a blinded fashion by intravenous infusion every 2 weeks for a total of 7 doses
- Primary Outcome Measures
Name Time Method The efficacy of itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids in achieving early disease response. Day 29 Complete response at Day 29
- Secondary Outcome Measures
Name Time Method Assess the impact of itolizumab versus placebo on other clinically relevant efficacy measures, Day 29 Overall Response Rates at Day 29
Evaluate the durability of response to itolizumab versus placebo as initial therapy for aGVHD in combination with corticosteroids. Day 99 Durable Complete Response rate from Day 29 through Day 99
Trial Locations
- Locations (118)
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
🇪🇸Sevilla, Spain
Hospital ClÃnico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
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
🇧🇪Antwerpen, Belgium
AZ Sint-Jan Brugge-Oostende AV
🇧🇪Brugge, Belgium
Cliniques Universitaires Saint-Luc; Hematology Department
🇧🇪Brussels, Belgium
UZ Leuven - Campus Gasthuisberg - Department of Hematology
🇧🇪Leuven, Belgium
CHU de Liege - Hematology Department
🇧🇪Liege, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Vancouver Coastal Health Authority
🇨🇦Vancouver, British Columbia, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
McGill University Health Center - Research Institute
🇨🇦Montréal, 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 Cedex 9, France
CHU de Lille - Hopital Claude Huriez
🇫🇷Lille, France
CHU de Nantes - Hôtel-Dieu
🇫🇷Lyon, France
Institut Paoli Calmettes - Hematology
🇫🇷Marseille, France
CHU Nice, Hospital l'Archet
🇫🇷Nice, France
AP-HP Hopital Saint-Louis
🇫🇷Paris, France
CHU Bordeaux - Hopital Haut-Leveque - Centre François Magendie
🇫🇷Pessac, France
HCL Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite, France
CHU de Rennes Hôpital Pontchaillou
🇫🇷Rennes Cedex 9, France
CHU Toulouse, Hematology
🇫🇷Toulouse, France
Institut Gustave Roussy - Hematology
🇫🇷Villejuif, France
Charité Universitätsmedizin Berlin, Tumorimmunologie Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Martin Luther Universitat Halle-Wittenberg
🇩🇪Halle, Germany
Universitätsklinikum Jena
🇩🇪Jena, Germany
Universitaetsklinikum Koeln (AoeR)
🇩🇪Köln, 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
🇮🇱Petach Tikva, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Chaim Sheba Medical Center
🇮🇱Tel HaShomer, 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
🇮🇹Firenze, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
🇮🇹Milano, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, 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
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Starship Children's Hospital
🇳🇿Auckland, New Zealand
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
🇵🇹Lisboa, Portugal
Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.
🇵🇹Porto, Portugal
Hospital Universitario Donostia
🇪🇸Donostia, 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