Clinical trial NCT05179057: Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adenovirus Infection
Keywords: Allogeneic Hematopoietic Cell Transplant
Adenoviremia
Adenovirus
Stem Cell Transplant
Posoleucel
ALVR105
Bone Marrow Transplant
Lead sponsor: AlloVir
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with option for blinded crossover to assess the safety and efficacy of posoleucel as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Undergone allogeneic cell transplantation ≥21 days prior to dosing
* Meet one of the below criteria:

  1. AdV viremia DNA ≥10,000 copies/mL, OR
  2. AdV viremia DNA results of ≥1,000 copies/mL, AND

     1. has absolute lymphocyte count \<180/mm3, OR
     2. has received T cell depletion OR
     3. had a cord blood transplant.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants With Undetectable Adenovirus Infection
timeFrame: Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)
measure: Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 34 weeks
Secondary outcomes:
measure: Number of Participants With Overall Disease Progression
timeFrame: From Day 29 up to Week 10
measure: Area Under the Curve (AUC) Adenovirus Viral Load
timeFrame: Pre-dose and Day 29
measure: Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29
timeFrame: Day 29
measure: Time to Undetectable Adenovirus Viremia (Less Than LLOQ)
timeFrame: Pre-dose to 34 weeks
measure: Number of Participants With Adenovirus Disease Recurrence
timeFrame: 34 weeks
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: MD Anderson Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles (UCLA)
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital - Stanford University
state: California
city: San Diego
country: United States
facility: University of California, San Diego - Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida (UF) - Gainesville
state: Florida
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain HealthCare - Primary Children's Hospital
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: The Hospital for Sick Children (SickKids)
state: Ontario
city: Montreal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
city: Napoli
country: Italy
facility: A.O.R.N. Santobono-Pausilipon
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
city: Torino
country: Italy
facility: Ospedale Regina Margherita
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Lund
country: Sweden
facility: Skane University Hospital Lund
city: Solna
country: Sweden
facility: Karolinska University Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Glasgow
country: United Kingdom
facility: Royal Hospital for Children - Glasgow
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital, Paddington
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
Study officials:
References: