NCT04390113

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)

Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant (HCT)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: AlloVir · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC).

Detailed 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).

Conditions

• BK Virus Infection
• Hemorrhagic Cystitis

Interventions

Type	Name	Description
BIOLOGICAL	Posoleucel (ALVR105)	Administered as 2-4 milliliter infusion, visually identical to placebo
BIOLOGICAL	Placebo	Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Timeline

• Start date: 2021-03-18
• Primary completion: 2024-01-30
• Completion: 2024-01-30
• First posted: 2020-05-15
• Last updated: 2024-05-14
• Results posted: 2024-05-14

Locations

56 sites across 7 countries: United States, France, Italy, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study