Adenovirus Infection Clinical Trial
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
Verified date | February 2024 |
Source | AlloVir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 51 |
Est. completion date | January 31, 2024 |
Est. primary completion date | January 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | CHU Sainte-Justine | Montreal | Quebec |
Canada | The Hospital for Sick Children (SickKids) | Toronto | Ontario |
Italy | IRCCS Ospedale San Raffaele | Milano | |
Italy | Fondazione IRCCS San Gerardo dei Tintori | Monza | |
Italy | A.O.R.N. Santobono-Pausilipon | Napoli | |
Italy | Azienda Ospedaliera di Padova | Padova | |
Italy | Fondazione IRCCS Policlinico San Matteo | Pavia | |
Italy | Ospedale Pediatrico Bambino Gesù | Roma | |
Italy | Ospedale Regina Margherita | Torino | |
Italy | Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento | Verona | |
Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitari i Politecnic La Fe | Valencia | |
Sweden | Sahlgrenska University Hospital | Gothenburg | |
Sweden | Skane University Hospital Lund | Lund | |
Sweden | Karolinska University Hospital | Solna | |
United Kingdom | Birmingham Children's Hospital | Birmingham | |
United Kingdom | Bristol Royal Hospital for Children | Bristol | |
United Kingdom | Royal Hospital for Children - Glasgow | Glasgow | |
United Kingdom | Great Ormond Street Hospital for Children | London | |
United Kingdom | St. Mary's Hospital, Paddington | London | |
United Kingdom | University College London Hospital | London | |
United Kingdom | Royal Manchester Children's Hospital | Manchester | |
United Kingdom | Sheffield Children's NHS Foundation Trust | Sheffield | |
United States | Children's Hospital Colorado - Center for Cancer and Blood Disorders | Aurora | Colorado |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University of Texas Southwestern | Dallas | Texas |
United States | City of Hope | Duarte | California |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | University of Florida (UF) - Gainesville | Gainesville | Florida |
United States | MD Anderson Cancer Center | Gilbert | Arizona |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | University of California, Los Angeles (UCLA) | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | New York Presbyterian Hospital | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Lucile Packard Children's Hospital - Stanford University | Palo Alto | California |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
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 | University of California, San Diego - Rady Children's Hospital | San Diego | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
AlloVir |
United States, Canada, Italy, Spain, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants with undetectable adenovirus infection | Primary Efficacy | 29 days | |
Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) | Primary Safety | 34 weeks | |
Secondary | Overall disease progression or non-relapse mortality | Key Secondary Efficacy | 34 weeks | |
Secondary | Mean area under the curve (AUC) AdV viral load | Other Secondary Efficacy | 29 days | |
Secondary | Proportion of participants who achieve AdV viremia <400 copies/mL | Other Secondary Efficacy | 29 days | |
Secondary | Time to undetectable AdV viremia (less than LLOQ) | Other Secondary Efficacy | 34 weeks | |
Secondary | Incidence of AdV disease recurrence | Other Secondary Efficacy | 34 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04722029 -
Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
|
Phase 1/Phase 2 | |
Completed |
NCT00711035 -
Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL)
|
Phase 1/Phase 2 | |
Completed |
NCT00880789 -
Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus
|
Phase 1 | |
Terminated |
NCT05305040 -
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
|
Phase 2/Phase 3 | |
Completed |
NCT02087306 -
Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection
|
Phase 3 | |
Active, not recruiting |
NCT03475212 -
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT00590083 -
Administration of Virus-Specific Cytotoxic T-Lymphocytes
|
Phase 1 | |
Recruiting |
NCT03159364 -
Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections
|
Phase 1/Phase 2 | |
Recruiting |
NCT05101213 -
Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients
|
Phase 1 | |
Completed |
NCT01070797 -
Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE)
|
Phase 1 | |
Active, not recruiting |
NCT04693637 -
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
|
Phase 2/Phase 3 | |
Withdrawn |
NCT02276820 -
Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A)
|
Phase 1 | |
Recruiting |
NCT02007356 -
A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®
|
Phase 2 | |
Withdrawn |
NCT02702427 -
Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT02851576 -
Clinical Grade Adenovirus Specific T Cells for Immunotherapy After Allogeneic Stem Cell Transplantation (CTL-ADV)
|
Phase 1/Phase 2 | |
Recruiting |
NCT04706923 -
A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA)
|
Phase 2 |