Spots Global Cancer Trial Database for Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
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Trial Identification
Brief Title: Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Official Title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Study ID: NCT05305040
Study Description
Brief Summary: This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Detailed Description: This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Children's of Alabama, Birmingham, Alabama, United States
Honor Health Research Institute, Scottsdale, Arizona, United States
City of Hope, Duarte, California, United States
University of California, Los Angeles (UCLA), Los Angeles, California, United States
Stanford University, Palo Alto, California, United States
University of California San Francisco - Benioff Children's Hospital, San Francisco, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, United States
Childrens National Health System, Washington, District of Columbia, United States
University of Florida (UF) - Gainesville, Gainesville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Loyola University Medical Center, Maywood, Illinois, United States
Indiana University Hospital Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States
University of Kansas Hospital, Kansas City, Kansas, United States
University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook University Hospital Cancer Center, Stony Brook, New York, United States
Carolinas Medical Center/Levine, Charlotte, North Carolina, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas, Dallas, Texas, United States
University of Utah/Primary Childrens Hospital, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Royal Adelaide Hospital, Adelaide, , Australia
Austin Health, Heidelberg, , Australia
Royal Brisbane and Women's Hospital, Herston, , Australia
Royal Melbourne Hospital, Parkville, , Australia
Queensland Children's Hospital, South Brisbane, , Australia
Westmead Hospital, Westmead, , Australia
A.Z. Sint-Jan Brugge Oostende AV, Brugge, , Belgium
Institut Jules Bordet and the Childrens Hospital, Bruxelles, , Belgium
University Hospital Gasthuisberg and Leuven, Leuven, , Belgium
Alberta Children's Hospital, Calgary, , Canada
Cellular Therapy Program - CHU Sainte-Justine (McGill), Montréal, , Canada
Hopital Maisonneve Rosemont, Montréal, , Canada
The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program, Toronto, , Canada
UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center, Toronto, , Canada
Leukemia/ BMT Program of British Columbia - Vancouver General Hospital, Vancouver, , Canada
Centre Hospitalier Regional Universitaire de Lille, Lille, , France
CHU de Nantes, Nantes, , France
AP-HP Hopital Saint-Louis, Paris, , France
Hopital Saint Antoine, Paris, , France
Hopital Universitaire Robert Debre, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
IUCT-Oncopole, Toulouse, , France
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
Ospedale San Raffaele, Milan, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy
IRCSS Ospedale Pediatrico Bambino Gesu, Roma, , Italy
University of Sacred Heart Policlinico A. Gemelli, Rome, , Italy
Humanitas Cancer Center, Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI), Verona, , Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Institut Catala d'Oncologia, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Acibadem Adana Hospital, Adana, , Turkey
Baskent Adana Hospital, Adana, , Turkey
Ankara Onkoloji Egitim Ve Arastirma Hastanesi, Ankara, , Turkey
Ankara University Hospital, Ankara, , Turkey
Gazi University Medical Faculty Hospital, Ankara, , Turkey
Medical Park Hospital, Antalya, , Turkey
Ege University Medical Faculty, Izmir, , Turkey
Anadolu Medical Center Hospital, Kocaeli, , Turkey
Inonu University Turgut Özal Medical Centre, Malatya, , Turkey
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
University Hospitals Bristol - Bristol Hospital for Children, Bristol, , United Kingdom
Addenbrooke's Hospital, Cambridge, , United Kingdom
Queen Elizabeth University Hospital - Glasgow, Glasgow, , United Kingdom
Great Ormond Street Hospital for Children, London, , United Kingdom
Contact Details
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