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Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
Full description
The study hypothesis is that the administration of posoleucel (ALVR105) to patients with virus-associated HC will demonstrate superiority for the time to resolution of HC (as measured by resolution of macroscopic hematuria) compared to patients treated with placebo. The primary hypothesis will be tested in patients with BK virus (BKV) viruria to demonstrate superiority over placebo in this population (BK Intent-to-Treat [ITT] Population). A supplementary analysis will be conducted in all patients with any virus-associated HC (cytomegalovirus [CMV], human herpesvirus 6 [HHV-6], Epstein-Barr virus [EBV], JC virus [JCV], and/or adenovirus [AdV]) in order to evaluate efficacy in this broader population (ITT Population).
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria
Participants must meet all of the following criteria in order to be eligible to participate in the study:
Male or female ≥1 year of age.
Had an allogeneic hematopoietic cell transplant (HCT) performed ≥21 days and ≤1 year prior to randomization.
Myeloid engraftment confirmed, defined as an absolute neutrophil count ≥500/mm³ for 3 consecutive laboratory values obtained on different days, and platelet count >10,000/mm³ at the time of randomization.
Diagnosed with HC based on the following criteria (all 3 criteria must be met):
At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.
Key Exclusion Criteria
Participants who meet any of the following criteria will be excluded from participation in the study:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
Allocation
Interventional model
Masking
97 participants in 2 patient groups, including a placebo group
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Central trial contact
Kyle Herbert
Data sourced from clinicaltrials.gov
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