Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
- Registration Number
- NCT05179057
- Lead Sponsor
- AlloVir
- Brief Summary
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).
- Detailed Description
During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 57
-
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.
-
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + SoC Placebo Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria Posoleucel + SoC Posoleucel Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) Up to 34 weeks A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.
Number of Participants With Undetectable Adenovirus Infection Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion) Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).
- Secondary Outcome Measures
Name Time Method Area Under the Curve (AUC) Adenovirus Viral Load Pre-dose and Day 29 Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29 Day 29 Number of Participants With Overall Disease Progression From Day 29 up to Week 10 Time to Undetectable Adenovirus Viremia (Less Than LLOQ) Pre-dose to 34 weeks Number of Participants With Adenovirus Disease Recurrence 34 weeks
Trial Locations
- Locations (47)
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Children's Hospital Colorado - Center for Cancer and Blood Disorders
🇺🇸Aurora, Colorado, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
CHU Sainte-Justine
🇨🇦Montreal, Quebec, Canada
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Fondazione IRCCS San Gerardo dei Tintori
🇮🇹Monza, Italy
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
MD Anderson Cancer Center
🇺🇸Gilbert, Arizona, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
University of California, San Diego - Rady Children's Hospital
🇺🇸San Diego, California, United States
University of Florida (UF) - Gainesville
🇺🇸Gainesville, Florida, United States
Lucile Packard Children's Hospital - Stanford University
🇺🇸Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Cook Children's Medical Center
🇺🇸Fort Worth, Texas, United States
The Hospital for Sick Children (SickKids)
🇨🇦Toronto, Ontario, Canada
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
A.O.R.N. Santobono-Pausilipon
🇮🇹Napoli, Italy
Ospedale Regina Margherita
🇮🇹Torino, Italy
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
🇮🇹Verona, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Bristol Royal Hospital for Children
🇬🇧Bristol, United Kingdom
Karolinska University Hospital
🇸🇪Solna, Sweden
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Skane University Hospital Lund
🇸🇪Lund, Sweden
Royal Hospital for Children - Glasgow
🇬🇧Glasgow, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital
🇬🇧Manchester, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
St. Mary's Hospital, Paddington
🇬🇧London, United Kingdom
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
City of Hope
🇺🇸Duarte, California, United States
Washington University School of Medicine in St. Louis
🇺🇸Saint Louis, Missouri, United States
Intermountain HealthCare - Primary Children's Hospital
🇺🇸Salt Lake City, Utah, United States
Sheffield Children's NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States