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

Primary Purpose

Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Posoleucel (ALVR105)
Placebo
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adenovirus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M, Virus-specific T cells (VSTs), Cytotoxic T Lymphocytes (CTLs)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • ≥1 year of 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 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment

  • 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 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 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.

Sites / Locations

  • University of Alabama at Birmingham Children's of AlabamaRecruiting
  • Honor Health Research InstituteRecruiting
  • City of HopeRecruiting
  • University of California, Los Angeles (UCLA)Recruiting
  • Stanford UniversityRecruiting
  • University of California San Francisco - Benioff Children's HospitalRecruiting
  • University of Colorado HospitalRecruiting
  • Yale University School of Medicine - Yale Cancer CenterRecruiting
  • Childrens National Health SystemRecruiting
  • University of Florida (UF) - GainesvilleRecruiting
  • Moffitt Cancer CenterRecruiting
  • Northside HospitalRecruiting
  • Loyola University Medical CenterRecruiting
  • Indiana University Hospital Simon Comprehensive Cancer CenterRecruiting
  • University of Kansas HospitalRecruiting
  • University of MarylandRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of MinnesotaRecruiting
  • Children's Mercy HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Hackensack University Medical CenterRecruiting
  • Roswell Park Cancer InstituteRecruiting
  • Columbia UniversityRecruiting
  • Weill Cornell Medical CollegeRecruiting
  • Stony Brook University Hospital Cancer CenterRecruiting
  • Carolinas Medical Center/LevineRecruiting
  • Nationwide Children's HospitalRecruiting
  • Oregon Health & Science UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Children's Medical Center DallasRecruiting
  • University of Utah/Primary Childrens HospitalRecruiting
  • University of VirginiaRecruiting
  • Virginia Commonwealth UniversityRecruiting
  • Fred Hutchinson Cancer Research CenterRecruiting
  • Froedtert Hospital and the Medical College of WisconsinRecruiting
  • Royal Adelaide HospitalRecruiting
  • Austin HealthRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Royal Melbourne HospitalRecruiting
  • Queensland Children's HospitalRecruiting
  • Westmead HospitalRecruiting
  • A.Z. Sint-Jan Brugge Oostende AVRecruiting
  • Institut Jules Bordet and the Childrens HospitalRecruiting
  • University Hospital Gasthuisberg and LeuvenRecruiting
  • Alberta Children's HospitalRecruiting
  • Cellular Therapy Program - CHU Sainte-Justine (McGill)Recruiting
  • Hopital Maisonneve RosemontRecruiting
  • Cellular Therapy Program - CHU Sainte-Justine (McGill)Recruiting
  • The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy ProgramRecruiting
  • UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer CenterRecruiting
  • Leukemia/ BMT Program of British Columbia - Vancouver General HospitalRecruiting
  • Centre Hospitalier Regional Universitaire de LilleRecruiting
  • CHU de NantesRecruiting
  • AP-HP Hopital Saint-LouisRecruiting
  • Hopital Saint AntoineRecruiting
  • Hopital Universitaire Robert DebreRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • IUCT-OncopoleRecruiting
  • Azienda Ospedaliero-Universitaria CareggiRecruiting
  • Ospedale San RaffaeleRecruiting
  • Fondazione I.R.C.C.S. Policlinico San MatteoRecruiting
  • IRCSS Ospedale Pediatrico Bambino GesuRecruiting
  • University of Sacred Heart Policlinico A. GemelliRecruiting
  • Humanitas Cancer CenterRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona (AOUI)Recruiting
  • Pusan National University HospitalRecruiting
  • Chonnam National University Hwasun HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Seoul St. Mary's HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Institut Catala d'OncologiaRecruiting
  • Hospital General Universitario Gregorio MaranonRecruiting
  • Hospital Regional Universitario de MalagaRecruiting
  • Hospital Universitari i Politecnic La Fe de ValenciaRecruiting
  • Acibadem Adana HospitalRecruiting
  • Baskent Adana HospitalRecruiting
  • Ankara Onkoloji Egitim Ve Arastirma HastanesiRecruiting
  • Ankara University HospitalRecruiting
  • Gazi University Medical Faculty HospitalRecruiting
  • Medical Park HospitalRecruiting
  • Ege University Medical FacultyRecruiting
  • Anadolu Medical Center HospitalRecruiting
  • Inonu University Turgut Özal Medical CentreRecruiting
  • Bristol Haematology and Oncology CentreRecruiting
  • University Hospitals Bristol - Bristol Hospital for ChildrenRecruiting
  • Addenbrooke's HospitalRecruiting
  • Queen Elizabeth University Hospital - GlasgowRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Posoleucel (ALVR105)

Placebo

Arm Description

Administered as 2-4 milliliter infusion, visually identical to placebo

Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)

Outcomes

Primary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease

Secondary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease
Number of clinically significant infections or episodes of end-organ disease due to each virus
Incidence of Adverse Events
Overall and Non-Relapse Mortality

Full Information

First Posted
March 22, 2022
Last Updated
July 14, 2023
Sponsor
AlloVir
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1. Study Identification

Unique Protocol Identification Number
NCT05305040
Brief Title
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Acronym
Prevent
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlloVir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Keywords
Allogeneic Hematopoietic Cell Transplant, ALVR105, Posoleucel, Viralym-M, Virus-specific T cells (VSTs), Cytotoxic T Lymphocytes (CTLs)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
302 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posoleucel (ALVR105)
Arm Type
Active Comparator
Arm Description
Administered as 2-4 milliliter infusion, visually identical to placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Intervention Type
Biological
Intervention Name(s)
Posoleucel (ALVR105)
Other Intervention Name(s)
Viralym-M
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to placebo
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Primary Outcome Measure Information:
Title
Number of clinically significant infections or episodes of end-organ disease
Time Frame
Through Week 14
Secondary Outcome Measure Information:
Title
Number of clinically significant infections or episodes of end-organ disease
Time Frame
Through Week 26
Title
Number of clinically significant infections or episodes of end-organ disease due to each virus
Time Frame
Through Week 14 and 25
Title
Incidence of Adverse Events
Time Frame
Through Week 26
Title
Overall and Non-Relapse Mortality
Time Frame
Through Week 26

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 >0.5 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dee Rodriguez
Phone
833-409-2281
Email
ClinicalTrials@allovir.com
Facility Information:
Facility Name
University of Alabama at Birmingham Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Honor Health Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco - Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University School of Medicine - Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Name
Childrens National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida (UF) - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
Indiana University Hospital Simon Comprehensive Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook University Hospital Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolinas Medical Center/Levine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Utah/Primary Childrens Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Heidelberg
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Melbourne Hospital
City
Parkville
Country
Australia
Individual Site Status
Recruiting
Facility Name
Queensland Children's Hospital
City
South Brisbane
Country
Australia
Individual Site Status
Recruiting
Facility Name
Westmead Hospital
City
Westmead
Country
Australia
Individual Site Status
Recruiting
Facility Name
A.Z. Sint-Jan Brugge Oostende AV
City
Brugge
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Institut Jules Bordet and the Childrens Hospital
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Name
University Hospital Gasthuisberg and Leuven
City
Leuven
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Alberta Children's Hospital
City
Calgary
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cellular Therapy Program - CHU Sainte-Justine (McGill)
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hopital Maisonneve Rosemont
City
Montréal
Country
Canada
Individual Site Status
Recruiting
Facility Name
Cellular Therapy Program - CHU Sainte-Justine (McGill)
City
Québec
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Name
Leukemia/ BMT Program of British Columbia - Vancouver General Hospital
City
Vancouver
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional Universitaire de Lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Name
AP-HP Hopital Saint-Louis
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Saint Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Universitaire Robert Debre
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
Country
France
Individual Site Status
Recruiting
Facility Name
IUCT-Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero-Universitaria Careggi
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale San Raffaele
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione I.R.C.C.S. Policlinico San Matteo
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCSS Ospedale Pediatrico Bambino Gesu
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Name
University of Sacred Heart Policlinico A. Gemelli
City
Rome
Country
Italy
Individual Site Status
Recruiting
Facility Name
Humanitas Cancer Center
City
Rozzano
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
City
Verona
Country
Italy
Individual Site Status
Recruiting
Facility Name
Pusan National University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Institut Catala d'Oncologia
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario de Malaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Name
Acibadem Adana Hospital
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Baskent Adana Hospital
City
Adana
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Onkoloji Egitim Ve Arastirma Hastanesi
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara University Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gazi University Medical Faculty Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Medical Park Hospital
City
Antalya
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ege University Medical Faculty
City
Izmir
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Anadolu Medical Center Hospital
City
Kocaeli
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu University Turgut Özal Medical Centre
City
Malatya
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bristol Haematology and Oncology Centre
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol - Bristol Hospital for Children
City
Bristol
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Elizabeth University Hospital - Glasgow
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital for Children
City
London
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
28783452
Citation
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.
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Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

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