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

Phase 3

Terminated

Conditions: BK Virus Infection
Hemorrhagic Cystitis

Interventions: Biological: Posoleucel (ALVR105)
Biological: Placebo

Registration Number: NCT04390113

Lead Sponsor: AlloVir

Brief 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).

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 97

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posoleucel (ALVR105)	Posoleucel (ALVR105)	Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo	Placebo	Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Primary Outcome Measures

Name	Time	Method
Time to Resolution of Macroscopic Hematuria	Up to 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Cytokine Release Syndrome (CRS)	Up to 24 weeks	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.
Average Daily Bladder Pain	Until event occurrence through Week 6
Time Until Bladder Pain is Resolved	Until event occurrence through Week 24
Days in the Hospital for Any Reason	Until event occurrence through Week 24
Number of Participants With Treatment Emergent Acute Graft Versus Host Disease (GVHD)	Up to 24 weeks	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 to Resolution for All Target Viruses	Until event occurrence through Week 24

Trial Locations

Locations (56): Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
🇺🇸
Cleveland, Ohio, United States
University of Miami
🇺🇸
Miami, Florida, United States
University of Minnesota
🇺🇸
Minneapolis, Minnesota, United States
Children's Hospital of Los Angeles
🇺🇸
Los Angeles, California, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Johns Hopkins Medicine
🇺🇸
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Children's Mercy Hospital - Kansas City
🇺🇸
Kansas City, Missouri, United States
Ohio State University Medical Center (OSUMC)
🇺🇸
Columbus, Ohio, United States
Children's Hospital of Philadelphia (CHOP)
🇺🇸
Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
🇺🇸
Seattle, Washington, United States
CHU de Nantes - Hôtel-Dieu
🇫🇷
Nantes, France
CHU de Lille - Hopital Claude Huriez
🇫🇷
Lille, France
AP-HP Hopital Saint-Louis
🇫🇷
Paris, France
IUCT-Oncopole
🇫🇷
Toulouse, France
Chonnam National University Hwasun Hospital
🇰🇷
Jeongnam, Korea, Republic of
Ospedale Pediatrico Bambino Gesù
🇮🇹
Roma, Italy
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷
Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷
Seoul, Korea, Republic of
Hospital Clinic Barcelona
🇪🇸
Barcelona, Spain
Hospital Universitario La Paz
🇪🇸
Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸
Málaga, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸
Valencia, Spain
Karolinska University Hospital
🇸🇪
Stockholm, Sweden
University Hospitals Bristol NHS Foundation Trust
🇬🇧
Bristol, United Kingdom
Great Ormond Street Hospital for Children
🇬🇧
London, United Kingdom
Queen Elizabeth University Hospital - Glasgow
🇬🇧
Glasgow, United Kingdom
Nottingham University Hospitals
🇬🇧
Nottingham, United Kingdom
University College London Hospital
🇬🇧
London, United Kingdom
The Royal Marsden NHS Foundation Trust
🇬🇧
London, United Kingdom
Hammersmith Hospital
🇬🇧
London, United Kingdom
University of Kansas Cancer Center
🇺🇸
Kansas City, Kansas, United States
City of Hope National Medical Center
🇺🇸
Duarte, California, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Children's National Medical Center
🇺🇸
Washington, District of Columbia, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
Yale University School of Medicine - Yale Cancer Center
🇺🇸
New Haven, Connecticut, United States
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
🇮🇹
Milano, Italy
Azienda Ospedaliero-Universitaria Careggi
🇮🇹
Firenze, Italy
IRCCS Ospedale San Raffaele
🇮🇹
Milano, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
🇮🇹
Rome, Italy
Istituto Clinico Humanitas
🇮🇹
Rozzano, Italy
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
🇮🇹
Verona, Italy
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
HCL Centre Hospitalier Lyon Sud
🇫🇷
Pierre-Bénite, France
Moffitt
🇺🇸
Tampa, Florida, United States
University of Nebraska Medical Center
🇺🇸
Omaha, Nebraska, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States
Northside Hospital
🇺🇸
Atlanta, Georgia, United States
The University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Roswell Park Comprehensive Cancer Center
🇺🇸
Buffalo, New York, United States