Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
NCT ID: NCT04390113
Last Updated: 2024-05-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
97 participants
INTERVENTIONAL
2021-03-18
2024-01-30
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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Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Interventions
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Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Eligibility Criteria
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Inclusion Criteria
* Male or female ≥1 year of age.
* Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
* Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count \>10,000/mm³ at the time of randomization.
* Diagnosed with HC based on the following criteria (all 3 criteria must be met):
1. Clinical signs and/or symptoms of cystitis.
2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
* At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.
Exclusion Criteria
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent).
* Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
* Evidence of active Grade \>2 acute graft versus host disease (GVHD).
* Uncontrolled or progressive bacterial or fungal infections.
* Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
* Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
* Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
* Pregnant or lactating or planning to become pregnant.
1 Year
ALL
No
Sponsors
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AlloVir
INDUSTRY
Responsible Party
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Locations
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City of Hope National Medical Center
Duarte, California, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
Moffitt
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Johns Hopkins Medicine
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Medical Center (OSUMC)
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, 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
CHU de Lille - Hopital Claude Huriez
Lille, , France
CHU de Nantes - Hôtel-Dieu
Nantes, , France
AP-HP Hopital Saint-Louis
Paris, , France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
IUCT-Oncopole
Toulouse, , France
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Ospedale Pediatrico Bambino Gesù
Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
Verona, , Italy
Chonnam National University Hwasun Hospital
Jeongnam, , South Korea
Asan Medical Center
Seoul, , South Korea
Pusan National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Karolinska University Hospital
Stockholm, , Sweden
University Hospitals Bristol NHS Foundation Trust
Bristol, , United Kingdom
Queen Elizabeth University Hospital - Glasgow
Glasgow, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
The Royal Marsden NHS Foundation Trust
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Nottingham University Hospitals
Nottingham, , United Kingdom
Countries
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References
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Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVM-003-HC
Identifier Type: -
Identifier Source: org_study_id
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