Cytomegalovirus Infections Clinical Trial
— PreventOfficial title:
Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (ALVR105,Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Verified date | April 2024 |
Source | AlloVir |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3 study to evaluate posoleucel (ALVR105, Viralym-M); 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.
Status | Terminated |
Enrollment | 451 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Key Inclusion Criteria: - Any age at the day of screening visit. - No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV - Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing - Meet one or more of the following criteria at the time of randomization: - Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR - Haploidentical donor - Matched or Mismatched unrelated donor - Use of umbilical cord blood as stem cell source - Ex vivo graft manipulation resulting in T cell depletion - Received anti-thymocyte globulin or alemtuzumab (Campath-1H) Key Exclusion Criteria: - History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization - Evidence of active Grade >2 acute GVHD - Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections - Known history or current (suspected) diagnosis of Grade =3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies - Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >1.0 mg/kg/day) within 24 hours prior to dosing - Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital | Adelaide | |
Australia | Austin Health | Heidelberg | |
Australia | Royal Brisbane and Women's Hospital | Herston | |
Australia | Royal Melbourne Hospital | Parkville | |
Australia | Queensland Children's Hospital | South Brisbane | |
Australia | Westmead Hospital | Westmead | |
Belgium | A.Z. Sint-Jan Brugge Oostende AV | Brugge | |
Belgium | Institut Jules Bordet and the Childrens Hospital | Bruxelles | |
Belgium | University Hospital Gasthuisberg and Leuven | Leuven | |
Canada | Alberta Children's Hospital | Calgary | |
Canada | Cellular Therapy Program - CHU Sainte-Justine (McGill) | Montréal | |
Canada | Hopital Maisonneve Rosemont | Montréal | |
Canada | The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program | Toronto | |
Canada | UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center | Toronto | |
Canada | Leukemia/ BMT Program of British Columbia - Vancouver General Hospital | Vancouver | |
France | Centre Hospitalier Regional Universitaire de Lille | Lille | |
France | CHU de Nantes | Nantes | |
France | AP-HP Hopital Saint-Louis | Paris | |
France | Hopital Saint Antoine | Paris | |
France | Hopital Universitaire Robert Debre | Paris | |
France | Centre Hospitalier Lyon Sud | Pierre-Bénite | |
France | IUCT-Oncopole | Toulouse | |
Italy | Azienda Ospedaliero-Universitaria Careggi | Firenze | |
Italy | Ospedale San Raffaele | Milan | |
Italy | Fondazione I.R.C.C.S. Policlinico San Matteo | Pavia | |
Italy | IRCSS Ospedale Pediatrico Bambino Gesu | Roma | |
Italy | University of Sacred Heart Policlinico A. Gemelli | Rome | |
Italy | Humanitas Cancer Center | Rozzano | |
Italy | Azienda Ospedaliera Universitaria Integrata Verona (AOUI) | Verona | |
Korea, Republic of | Pusan National University Hospital | Busan | |
Korea, Republic of | Chonnam National University Hwasun Hospital | Hwasun | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
Korea, Republic of | Seoul St. Mary's Hospital | Seoul | |
Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
Spain | Institut Catala d'Oncologia | Barcelona | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Regional Universitario de Malaga | Málaga | |
Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | |
Turkey | Acibadem Adana Hospital | Adana | |
Turkey | Baskent Adana Hospital | Adana | |
Turkey | Ankara Onkoloji Egitim Ve Arastirma Hastanesi | Ankara | |
Turkey | Ankara University Hospital | Ankara | |
Turkey | Gazi University Medical Faculty Hospital | Ankara | |
Turkey | Medical Park Hospital | Antalya | |
Turkey | Ege University Medical Faculty | Izmir | |
Turkey | Anadolu Medical Center Hospital | Kocaeli | |
Turkey | Inonu University Turgut Özal Medical Centre | Malatya | |
United Kingdom | Bristol Haematology and Oncology Centre | Bristol | |
United Kingdom | University Hospitals Bristol - Bristol Hospital for Children | Bristol | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | Queen Elizabeth University Hospital - Glasgow | Glasgow | |
United Kingdom | Great Ormond Street Hospital for Children | London | |
United States | Northside Hospital | Atlanta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | University of Maryland | Baltimore | Maryland |
United States | University of Alabama at Birmingham Children's of Alabama | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Carolinas Medical Center/Levine | Charlotte | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Children's Medical Center Dallas | Dallas | Texas |
United States | City of Hope | Duarte | California |
United States | University of Florida (UF) - Gainesville | Gainesville | Florida |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Indiana University Hospital Simon Comprehensive Cancer Center | Indianapolis | Indiana |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | University of California, Los Angeles (UCLA) | Los Angeles | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | Yale University School of Medicine - Yale Cancer Center | New Haven | Connecticut |
United States | Columbia University | New York | New York |
United States | Weill Cornell Medical College | New York | New York |
United States | Stanford University | Palo Alto | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | University of Utah/Primary Childrens Hospital | Salt Lake City | Utah |
United States | University of California San Francisco - Benioff Children's Hospital | San Francisco | California |
United States | Honor Health Research Institute | Scottsdale | Arizona |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Stony Brook University Hospital Cancer Center | Stony Brook | New York |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Childrens National Health System | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
AlloVir |
United States, Australia, Belgium, Canada, France, Italy, Korea, Republic of, Spain, Turkey, United Kingdom,
Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.
Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14 | The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV). | Through Week 14 | |
Secondary | Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26 | The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV. | Through Week 26 | |
Secondary | Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus | The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV. | Through Week 14 |
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