- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390113
Study to Evaluate Viralym-M (ALVR105) for the Treatment of Virus-Associated Hemorrhagic Cystitis (HC)
February 1, 2024 updated by: AlloVir
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)
A study to evaluate posoleucel (ALVR105); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kyle Herbert
- Phone Number: +1 833-409-2281
- Email: ClinicalTrials@allovir.com
Study Locations
-
-
-
Lille, France
- CHU de Lille - Hopital Claude Huriez
-
Nantes, France
- CHU de Nantes - Hôtel-Dieu
-
Paris, France
- AP-HP Hopital Saint-Louis
-
Pierre-Bénite, France
- HCL Centre Hospitalier Lyon Sud
-
Toulouse, France
- IUCT-Oncopole
-
-
-
-
-
Firenze, Italy
- Azienda Ospedaliero-Universitaria Careggi
-
Milano, Italy
- Irccs Ospedale San Raffaele
-
Milano, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
-
Roma, Italy
- Ospedale Pediatrico Bambino Gesù
-
Rome, Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
-
Rozzano, Italy
- Istituto Clinico Humanitas
-
Verona, Italy
- Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
-
-
-
-
-
Jeongnam, Korea, Republic of
- Chonnam National University Hwasun Hospital
-
Seoul, Korea, Republic of
- Seoul National University Hospital
-
Seoul, Korea, Republic of
- Asan Medical Center
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
Seoul, Korea, Republic of
- Severance Hospital, Yonsei University Health System
-
Seoul, Korea, Republic of
- Seoul St. Mary's Hospital, The Catholic University of Korea
-
Seoul, Korea, Republic of
- Pusan National University Hospital
-
-
-
-
-
Barcelona, Spain
- Hospital Clinic Barcelona
-
Madrid, Spain
- Hospital Universitario La Paz
-
Málaga, Spain
- Hospital Regional Universitario de Málaga
-
Valencia, Spain
- Hospital Universitari I Politecnic La Fe
-
-
-
-
-
Stockholm, Sweden
- Karolinska University Hospital
-
-
-
-
-
Bristol, United Kingdom
- University Hospitals Bristol NHS Foundation Trust
-
Glasgow, United Kingdom
- Queen Elizabeth University Hospital - Glasgow
-
London, United Kingdom
- University College London Hospital
-
London, United Kingdom
- Hammersmith Hospital
-
London, United Kingdom
- Great Ormond Street Hospital for Children
-
London, United Kingdom
- The Royal Marsden NHS Foundation Trust
-
Nottingham, United Kingdom
- Nottingham University Hospitals
-
-
-
-
California
-
Duarte, California, United States, 91010
- City of Hope National Medical Center
-
Los Angeles, California, United States, 90027
- Children's Hospital of Los Angeles
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale University School of Medicine - Yale Cancer Center
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- Children's National Medical Center
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
Tampa, Florida, United States, 33612
- Moffitt
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Northside Hospital
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Cancer Center
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Medicine
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02215
- Massachusetts General Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital - Kansas City
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Comprehensive Cancer Center
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
-
Columbus, Ohio, United States, 43210
- Ohio State University Medical Center (OSUMC)
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia (CHOP)
-
-
Texas
-
Dallas, Texas, United States, 75390
- The University of Texas Southwestern Medical Center
-
-
Virginia
-
Richmond, Virginia, United States, 23284
- Virginia Commonwealth University
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital and the Medical College of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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):
- Clinical signs and/or symptoms of cystitis.
- Grade ≥3 hematuria, defined as macroscopic hematuria with visible clots.
- 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.
Key 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
|
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
|
Experimental: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
|
Administered as 2-4 milliliter infusion, visually identical to placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time until urine is visually clear of hematuria
Time Frame: Until event occurrence through week 24
|
Until event occurrence through week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time until bladder pain is resolved
Time Frame: Until event occurrence through week 24
|
Until event occurrence through week 24
|
Days in the hospital for any reason
Time Frame: Until event occurrence through week 24
|
Until event occurrence through week 24
|
Time to resolution for target all viruses
Time Frame: Until event occurrence through week 24
|
Until event occurrence through week 24
|
Average daily bladder/lower abdominal pain
Time Frame: Until event occurrence through week 6
|
Until event occurrence through week 6
|
Incidence and severity of acute graft versus host disease and cytokine release syndrome
Time Frame: Until event occurance through week 24
|
Until event occurance through week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 18, 2021
Primary Completion (Actual)
January 31, 2024
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
May 12, 2020
First Submitted That Met QC Criteria
May 12, 2020
First Posted (Actual)
May 15, 2020
Study Record Updates
Last Update Posted (Actual)
February 2, 2024
Last Update Submitted That Met QC Criteria
February 1, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVM-003-HC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on BK Virus Infection
-
AlloVirWithdrawnBK Virus InfectionUnited States
-
King Chulalongkorn Memorial HospitalRecruitingBK Virus Infection | Kidney Transplant Infection | BK Virus NephropathyThailand
-
University Hospital, Strasbourg, FranceRecruiting
-
SL VAXiGENSL BIGENUnknownBK Virus Infection | Cytomegalovirus Infections | Preventation of Cytomegalovirus Reactivation | Preventation of BK Virus ReactivationKorea, Republic of
-
Dana-Farber Cancer InstituteActive, not recruiting
-
King Chulalongkorn Memorial HospitalRecruitingBK Virus Infection | Kidney Transplant InfectionThailand
-
Children's Hospital of PhiladelphiaRecruitingBK PolyomavirusUnited States
-
Loma Linda UniversityWithdrawnBK Virus Infection | BK Virus NephropathyUnited States
-
University Hospital, Strasbourg, FranceNot yet recruitingBK Virus InfectionFrance
-
University of California, San FranciscoCompletedBK Virus InfectionUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States