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

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ClinicalTrials.gov Identifier: NCT05179057
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : August 3, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

Tracking Information
First Submitted Date  ICMJE December 17, 2021
First Posted Date  ICMJE January 5, 2022
Last Update Posted Date August 3, 2022
Actual Study Start Date  ICMJE May 11, 2022
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2022)
  • Proportion of participants with undetectable viremia (less than lower limit of quantitation [LLOQ]) at Day 29 [ Time Frame: 29 days ]
    Primary efficacy
  • Incidence and severity of adverse events (AEs), including AE's of special interest (AESIs) [ Time Frame: 29 days ]
    Primary safety
  • Incidence and severity of acute GVHD during the study [ Time Frame: 29 days ]
    Primary safety
  • Incidence and severity of chronic GVHD during the study. [ Time Frame: 29 days ]
    Primary safety
  • Incidence and severity of CRS during the study [ Time Frame: 29 days ]
    Primary safety
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2022)
  • Proportion of participants with disease progression or non-relapse mortality by Day 29. [ Time Frame: 29 days ]
  • Proportion of participants with undetectable viremia (less than LLOQ) at Day 29 in participants without AdV disease at screening. [ Time Frame: 29 days ]
  • Proportion of participants with undetectable viremia (less than LLOQ) at Day 29 in participants with AdV disease at screening. [ Time Frame: 29 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Adenovirus Infection
Intervention  ICMJE
  • Drug: Posoleucel
    Administered as 2-4 milliliter infusion, visually identical to placebo
  • Drug: Placebo
    Administered as 2-4 milliliter infusion, visually identical to Posoleucel
Study Arms  ICMJE
  • Experimental: Posoleucel + SoC
    Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
    Intervention: Drug: Posoleucel
  • Placebo Comparator: Placebo + SoC
    Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 4, 2022)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2024
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female >1 year of age.
  • Has undergone allogeneic cell transplantation ≥21 days prior to randomization and demonstrated engraftment with an absolute neutrophil count >500/mm^3, AND has one of the following:

    1. AdV viremia DNA ≥10,000 copies/mL at screening, OR
    2. Two consecutive and rising AdV viremia DNA results of ≥1,000 copies/mL at screening, AND

      1. has absolute lymphocyte count <180/mm3, OR
      2. has received T cell depletion.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and refrain from donating sperm or eggs for at least 90 days after treatment completion.
  • Willing and able to provide signed informed consent.
  • Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.

Exclusion Criteria:

  • Grade >2 acute GVHD
  • Ongoing therapy with high-dose systemic corticosteroids
  • Grade 4 diarrhea
  • Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
  • Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation.
  • Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
  • Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to randomization.
  • Use of vasopressors within 7 days prior to randomization.
  • Use of any investigational antiviral agent, including brincidofovir, within 7 days prior to randomization.
  • Lactating female unwilling to discontinue nursing prior to randomization.
  • Severe allergy to any component of posoleucel or history of severe prior reactions to blood product transfusions.
  • Positive for SARS-CoV-2 virus at screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chrissy Pelland +1 833-409-2281 ClinicalTrials@allovir.com
Listed Location Countries  ICMJE Italy,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05179057
Other Study ID Numbers  ICMJE P-105-303
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AlloVir
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AlloVir
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AlloVir
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP