Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Adenovirus Infection

In brief

This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).

Key facts

Study ID

NCT05179057

Run by

AlloVir

People needed

57

Starts

2022-04-26

Expected to finish

2024-01-31

Last updated by the study team

2024-05-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergone allogeneic cell transplantation ≥21 days prior to dosing
• Meet one of the below criteria:
• AdV viremia DNA ≥10,000 copies/mL, OR
• AdV viremia DNA results of ≥1,000 copies/mL, AND
• has absolute lymphocyte count <180/mm3, OR
• has received T cell depletion OR
• had a cord blood transplant.

You may not qualify if…

• Grade 3 or higher acute GVHD
• Ongoing therapy with high-dose systemic corticosteroids
• Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
• Pregnant or lactating female unwilling to discontinue nursing prior to randomization
• History of severe prior reactions to blood product transfusions
• NOTE: Other protocol-defined inclusion/exclusion criterion may apply.

Where it is running

• Royal Hospital for Children - Glasgow — Glasgow, United Kingdom
• MD Anderson Cancer Center — Gilbert, Arizona, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• City of Hope — Duarte, California, United States
• University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Lucile Packard Children's Hospital - Stanford University — Palo Alto, California, United States
• University of California, San Diego - Rady Children's Hospital — San Diego, California, United States
• Children's Hospital Colorado - Center for Cancer and Blood Disorders — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• University of Florida (UF) - Gainesville — Gainesville, Florida, United States
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine in St. Louis — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York Presbyterian Hospital — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States
• University of Texas Southwestern — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Intermountain HealthCare - Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• The Hospital for Sick Children (SickKids) — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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