NCT01822093

Brief Summary

Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy without toxicity or increasing the occurrence of Graft Versus Host Disease. This is a Phase I/IIa open-label safety study, assessing the effects of administering adenovirus-specific T-cells (Cytovir ADV) to paediatric patients post haematopoietic stem cell transplant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

4.1 years

First QC Date

February 11, 2013

Last Update Submit

January 23, 2018

Conditions

ADV Infection Post Allo-HSCT

Outcome Measures

Primary Outcomes (2)

  • Number of subjects with new onset GVHD

    180 days

  • number of subjects developing NCI Grade 3-4 adverse events

    180 days

Secondary Outcomes (6)

  • Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)

    180 days

  • Number of detectable HAdV-specific T-cells in vivo at each time point

    180 days

  • Requirement for second infusion of HAdV-specific T-cells

    180 days

  • Number of treatment days with antiviral drugs

    180 days

  • Number of treatment days with other anti-infective drugs

    180 days

  • +1 more secondary outcomes

Study Arms (1)

Cytovir-ADV

EXPERIMENTAL

Adenovirus-specific T-cells

Biological: Cytovir-ADV

Interventions

Cytovir-ADVBIOLOGICAL

A single dose 1x10e4 CD3+ T cells/kg patient weight of Cytovir ADV is prescribed to patients on exhibiting two consecutive PCR positive Adenovirus viraemia results \> 1000 copies/ml. Patients are followed up by continued monitoring of Adenovirus viraemia results. If patients exhibit uncontrolled ADV viraemia at ≥ 4 weeks following the first cell dose, they will be prescribed a second cell dose of 10e5 CD3+ T cell/kg. Patients will be monitored for 6 months following infusion of Cytovir ADV. This is a feasibility/pilot study and has no control group

Also known as: Adenovirus-specific T-cells
Cytovir-ADV

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients:
  • Age 16 years or younger
  • Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
  • The subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent
  • Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.
  • Donors
  • Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
  • Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
  • Passed medical assessment for stem cell donation
  • HdADV seropositive
  • Signed informed consent
  • Age 16 years or older

You may not qualify if:

  • Patients
  • Pregnant or lactating females
  • Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
  • Human Immunodeficiency Virus (HIV) infection
  • Donors
  • Pregnant or lactating females
  • (assessed prior to apheresis) Platelets \< 50x109/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Great Ormond Street Hospital

London, United Kingdom

Location

Royal Manchester Children's Hospital

Manchester, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

Study Officials

  • Waseem Qasim

    Institute of Child Health, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2013

First Posted

April 2, 2013

Study Start

December 1, 2012

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

GB(3)