Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia
Adenovirus
About this trial
This is an interventional treatment trial for Adenovirus
Eligibility Criteria
Inclusion Criteria:
- Be ≥ 18-years-old (or per local law or regulations on legal age of consent).
- Have received an allogeneic hematopoietic cell transplant (HCT) within the previous 100 days.
- Have plasma AdV DNA viremia ≥ 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory).
Exclusion Criteria:
- Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater
Acute graft versus host disease (GVHD)
- NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin > 3 mg/dL : > 51 μmol/L) within 7 days prior to Day 1
- Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1
- Concurrent human immunodeficiency virus or active hepatitis B or C infection
- An estimated creatinine clearance of < 30 mL/min, and/or use of renal replacement therapy within 7 days prior to Day 1.
- Poor clinical prognosis, including active malignancy, irreversible organ failure, use of vasopressors, requirement for mechanical ventilation, resting oxygen saturation < 88%, or Pulmonary Arterial oxygen (PaO2) ≤ 55 mm Hg without supplemental oxygen at any time within 7 days prior to Day 1.
- Receiving or anticipated to start systemic cyclosporine immunosuppressant treatment during study participation.
- Received treatment with CDV within 14 days prior to Day 1.
- Previous receipt of cell-based anti-AdV therapy within 6 weeks prior to Day 1 or prior receipt of an anti-AdV vaccine at any time.
- Consumed food products containing sesame seeds, sesame oil, or dietary supplements containing sesamin within 3 days prior to Day 1.
- Received any investigational drug within 28 days prior to Day 1 or currently participating in another interventional study.
- Pregnant or breastfeeding.
Sites / Locations
- UCLA Medical Center
- University of Chigago
- Brigham and Womens Hospital
- MD Anderson Cancer Center
- University Vita-Salute San Raffaele. San Faffaele Scientific Institute
- Hospital Universitari Vall d'Hebron
- Hospital Clinico Universitario de Salamanca
- Hospital Universitari I Politecnic la Fe
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Brincidofovir (BCV)
Standard of Care (SoC)
Cohort 1: BCV 10 mg twice weekly via IV infusion over 2 hours Cohort 2: BCV 15 mg twice weekly via IV infusion over 2 hours Cohort 3: BCV In Cohort 3, the actual dose may be higher or lower than doses administered in previous cohorts; the maximum dose of IV BCV will be ≤ 25 mg.
Subjects randomized to the SoC in each cohort will be managed per local institutional guidelines and investigator judgement. SoC treatment options may include, but are not limited to, taking a "watch and-wait" approach, with or without decreased immunosuppression (i.e., no active treatment), or treatment with IV Cidofovir (CDV), ganciclovir, or ribavirin.