Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
97
Administered as 2-4 milliliter infusion, visually identical to placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Time to Resolution of Macroscopic Hematuria
Time to macroscopic hematuria resolution is calculated from time of randomization to the first date of observed macroscopic hematuria resolution. Kaplan-Meier estimates reported as median number of days to resolution. Participants were censored at the last follow-up time of any participant in the ITT population if they took definitive therapies to stop bladder bleeding or received treatment for hemorrhagic cystitis with non-PSL VSTs before achieving resolution or deceased. Participants were also censored at last follow up if they failed to achieve resolution by end of study.
Time frame: Up to 24 weeks
Time Until Bladder Pain is Resolved
Time frame: Until event occurrence through Week 24
Days in the Hospital for Any Reason
Time frame: Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)
Grading of acute GVHD is reported according to CTCAE version 5.0 which ranges from Grade 0 (best/no disease) to Grade IV (worst). Participants with Grade I-IV are included.
Time frame: Up to 24 weeks
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)
CRS is defined as a supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at the onset, and may include hypotension, capillary leak (hypoxia), and end organ dysfunction.
Time frame: Up to 24 weeks
Time to Resolution for All Target Viruses
Time frame: Until event occurrence through Week 24
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Average Daily Bladder Pain
Time frame: Until event occurrence through Week 6