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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05305040




Registration number
NCT05305040
Ethics application status
Date submitted
22/03/2022
Date registered
31/03/2022

Titles & IDs
Public title
Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Scientific 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
Secondary ID [1] 0 0
P-105-202 Phase 3
Universal Trial Number (UTN)
Trial acronym
Prevent
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adenovirus Infection 0 0
BK Virus Infection 0 0
Cytomegalovirus Infections 0 0
Epstein-Barr Virus Infections 0 0
Human Herpes Virus-6 Infection 0 0
JC Virus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Posoleucel (ALVR105)
Treatment: Other - Placebo

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

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


Treatment: Other: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo

Treatment: Other: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
Timepoint [1] 0 0
Through Week 14
Secondary outcome [1] 0 0
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26
Timepoint [1] 0 0
Through Week 26
Secondary outcome [2] 0 0
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus
Timepoint [2] 0 0
Through Week 14

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/01/2024
Sample size
Target
Accrual to date
Final
451
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Massachusetts
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Missouri
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Brugge
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Belgium
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Bruxelles
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Leuven
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Calgary
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Lille
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France
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Nantes
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France
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Paris
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France
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Pierre-Bénite
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France
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Toulouse
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Italy
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Firenze
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Milan
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Italy
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Pavia
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Italy
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Roma
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Italy
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Rome
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Italy
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Rozzano
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Italy
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Verona
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Korea, Republic of
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Busan
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Hwasun
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Cambridge
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Glasgow
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AlloVir
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05305040