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Study of Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)
Dee Rodriguez - ClinicalTrials@allovir.com
NCT05305040
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Key
• ≥1 year of age at the day of screening visit.
• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
• Haploidentical donor
• Matched or Mismatched unrelated donor
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key
• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Inclusion Criteria:
• ≥1 year of age at the day of screening visit.
• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
• Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment
• Meet one or more of the following criteria at the time of randomization:
• Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
• Haploidentical donor
• Matched or Mismatched unrelated donor
• Use of umbilical cord blood as stem cell source
• Ex vivo graft manipulation resulting in T cell depletion
• Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key
Exclusion Criteria:
• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
• Evidence of active Grade >2 acute GVHD
• Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
• Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 mg/kg/day) within 24 hours prior to dosing
• Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Biological: Posoleucel (ALVR105), Biological: Placebo
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M
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Study Locations
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| Location | Contacts |
|---|---|
| A.Z. St. Jan Brugge, | |
| Acibadem Adana Hospital Seyhan, Adana | |
| Addenbrooke's Hospital Cambridge, | |
| Alberta Children's Hospital Calgary, Alberta | |
| Anadolu Medical Center Hospital Gebze, | |
| Ankara Abdurrahman Yurtaslan Hospital Ankara, | |
| Ankara University Medical Faculty Ankara, | |
| Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento Verona, | |
| Azienda Ospedaliero-Universitaria Careggi Florence, | |
| Barns Jewish Hospital Saint Louis, Missouri | |
| Baskent Adana Hospital Adana, | |
| Bristol Haematology and Oncology Centre Bristol, | |
| CHU de Nantes Nantes, | |
| Cellular Therapy Program - CHU Sainte-Justine (McGill) Québec, | |
| Centre Hospitalier Lyon Sud Pierre-Bénite, | |
| Centre Hospitalier Regional Universitaire de Lille Lille, | |
| Cheonam National University Hwasun Hospital Hwasun, | |
| Children's Medical Center Dallas Dallas, Texas | |
| Children's Mercy Hospital - Kansas City Kansas City, Missouri | |
| Children's National Medical Center Washington D.C., District of Columbia | |
| Childrens National Health System Washington, District of Columbia | |
| City of Hope Duarte, California | |
| Columbia University New York, New York | |
| Dana Farber Cancer Institute Boston, Massachusetts | |
| Ege University Medical Faculty Izmir, | |
| Fondazione I.R.C.C.S. Policlinico San Matteo Pavia, | |
| Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore Rome, | |
| Fred Hutchinson Cancer Research Center Seattle, Washington | |
| Froedtert Hospital and the Medical College of Wisconsin Milwaukee, Wisconsin | |
| Gazi University Medical Faculty Hospital Ankara, | |
| Great Ormond Street Hospital For Children London, | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Honor Health Scottsdale, Arizona | |
| Hopital Maisonneve Rosemont Montreal, | |
| Hopital Saint Antoine Paris, | |
| Hopital Universitaire Robert Debre Paris, | |
| Hospital General Universitario Gregorio Marañon Madrid, | |
| Hospital Saint-Louis Paris, | |
| Hospital Universitari i Politecnic La Fe de Valencia Valencia, | |
| IRCCS Ospedale San Raffaele Milan, | |
| Indiana University Hospital Indianapolis, Indiana | |
| Inonu University Turgut Özal Medical Centre Malatya, | |
| Institut Catala d'Oncologia Barcelona, | |
| Institut Claudius Regaud Cancer Comprehensive Center - IUCT Oncopole Toulouse, | |
| Institut Jules Bordet and the Childrens Hospital Anderlecht, | |
| Istituto Clinico Humanitas Rozzano, Lombardy | |
| King's College Hospital London, | |
| Leukemia/BMT Program of British Columbia Vancouver, | |
| Levine Cancer Center Charlotte, North Carolina | |
| Loyola University Maywood, Illinois | |
| MOFFITT Tampa, Florida | |
| Medical Park Hospital Istanbul, | |
| Nationwide Children's Hospital Columbus, Ohio | |
| Northside Hospital Atlanta, Georgia | |
| Olivia Newton John Hospital Heidelberg, | |
| Oregon Health & Science University Portland, Oregon | |
| Ospedale Pediatrico Bambino Gesu Rome, | |
| Pusan National University Hospital Busan, | |
| Queen Elizabeth University Hospital Glasgow, | |
| Queensland Children's Hospital South Brisbane, Queensland | |
| Roswell Park Comprehensive Cancer Center Buffalo, New York | |
| Royal Adelaide Hospital Adelaide, South Australia | |
| Royal Brisbane and Women's Hospital Brisbane, Queensland | |
| Royal Melbourne Hospital Parkville VIC, Australia | |
| Samsung Medical Center Seoul, | |
| Seoul National University Hospital Seoul, | |
| Seoul St. Mary's Hospital, The Catholic University of Korea Seoul, | |
| Severance Hospital, Yonsei University Health System Seoul, | |
| St Vincents Hospital Sydney Limited Darlinghurst, | |
| Stanford University Palo Alto, California | |
| Stony Brook University Hospital Cancer Center Stony Brook, New York | |
| The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program Toronto, | |
| UCLA Los Angeles, California | |
| UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Toronto, | |
| Unidad De Hemofilia, Hospital Regional Universitario De Malaga Málaga, | |
| University Hospital Gasthuisberg and Leuven Leuven, | |
| University Hospitals Bristol Bristol, | |
| University Utah Childrens Hospital Salt Lake City, Utah | |
| University of Alabama at Birmingham Birmingham, Alabama | |
| University of California, San Francisco Medical Center San Francisco, California | |
| University of Chicago Chicago, Illinois | |
| University of Colorado Hospital Aurora, Colorado | |
| University of Florida - Division of Hematology & Oncology Gainesville, Florida | |
| University of Kansas Cancer Center Kansas City, Kansas | |
| University of Maryland Medical Center Baltimore, Maryland | |
| University of Minnesota Minneapolis, Minnesota | |
| University of Pennsylvania Philadelphia, Pennsylvania | |
| University of Sacred Heart Policlinico A. Gemelli Rome, | |
| University of Virginia Charlottesville, Virginia | |
| Vanderbilt University Medical Center Nashville, Tennessee | |
| Virginia Commonwealth University Richmond, Virginia | |
| Washington University School of Medicine St Louis, Missouri | |
| Weil Medical College - NY Presbyterian Hospital New York, New York | |
| Westmead Hospital Westmead, New South Wales | |
| Yale University School of Medicine New Haven, Connecticut |