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Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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)

NCT04390113•AlloVir

View on ClinicalTrials.gov

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).

Eligibility

Age

1 - No limit years

Sex

ALL

Healthy Volunteers

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):
•1. Clinical signs and/or symptoms of cystitis.
•2. Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
•3. Viruria with ≥1 target virus (ie, BKV, JCV, AdV, CMV, EBV, and/or HHV-6).
•At least 1 identified, suitably matched posoleucel (ALVR105) cell line for infusion is available.

Exclusion Criteria

•Participants who meet any of the following criteria will be excluded from participation in the study:
•Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose \>0.5 mg/kg/day or equivalent).
•Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies ≤28 days before randomization.
•Evidence of active Grade \>2 acute graft versus host disease (GVHD).
•Uncontrolled or progressive bacterial or fungal infections.
•Uncontrolled or progressive viral infections not targeted by posoleucel (ALVR105).
•Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
•Known or presumed pneumonia secondary to any organism that is not considered to be well-controlled by antimicrobial therapy.
•Pregnant or lactating or planning to become pregnant.

Locations (56)

City of Hope National Medical Center

Duarte, California, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Miami

Miami, Florida, United States

Moffitt

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Key Dates

Start Date

March 18, 2021

Primary Completion Date

January 30, 2024

Completion Date

January 30, 2024

Last Updated

May 14, 2024

Enrollment

ACTUAL participants

Conditions

BK Virus InfectionHemorrhagic Cystitis

Interventions

Posoleucel (ALVR105)

BIOLOGICAL

Placebo

BIOLOGICAL

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient

NCT04542733

Kidney Transplant InfectionBK Virus Infection

View study

RECRUITINGPHASE3

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

NCT05726786

Bladder CancerInterstitial Cystitis+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia

Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant