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Phase 3 Randomized Trial for Refractory ADV or CMV Infection With Family Matched CTLs and Standard of Care (SOC) vs SOC Alone

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Notable Recruitment openedv2 Show 4 more changesShow less
    • Enrollment increased: 69 → 138 participants
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 1, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 14 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with refractory ADV or CMV infection post allogeneic stem cell transplant will be randomized to either Family donor-derived viral specific cytotoxic T lymphocytes (CTLs) plus standard of care (SOC) vs SOC alone.
Trial Details
NCT Number NCT07225972
Lead Sponsor New York Medical College
Conditions
(from sponsor)
CMV, AdV Infection, AdV Reactivation, Adenovirus, Cytomegalovirus Infections
Related terms Adenoviridae Infections, Cytomegalovirus Infections
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov