ADV Infection Post Allo-HSCTPhase 1/2ASPIRENCT01822093
Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT
A Phase 1/2 study testing Cytovir-ADV in people with ADV Infection Post Allo-HSCT, run by Cell Medica Ltd at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- ADV Infection Post Allo-HSCT
- What is being tested?
- Cytovir-ADV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Dec 2012to 31 Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Great Ormond Street Hospital
London
Royal Manchester Children's Hospital
Manchester
Royal Victoria Infirmary
Newcastle
About this study
Official title: Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation
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.
- Conditions
- ADV Infection Post Allo-HSCT
- Being tested
- Cytovir-ADV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytovir-ADVBiological
Also called Adenovirus-specific T-cells
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
| Study group | Role | What they receive |
|---|---|---|
| Cytovir-ADV | Experimental | Adenovirus-specific T-cells Receives: Biological: Cytovir-ADV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with new onset GVHD
Measured: 180 days
number of subjects developing NCI Grade 3-4 adverse events
Measured: 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)
Measured: 180 days
Number of detectable HAdV-specific T-cells in vivo at each time point
Measured: 180 days
Requirement for second infusion of HAdV-specific T-cells
Measured: 180 days
Number of treatment days with antiviral drugs
Measured: 180 days
Number of treatment days with other anti-infective drugs
Measured: 180 days
Number of in-hospital days during 6 month post-infusion period
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startDec 2012
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADV Infection Post Allo-HSCTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cell Medica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Technology Strategy Board, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Waseem Qasim, Principal investigator, Institute of Child Health, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822093
- Sponsor's protocol ID
- CM-2011-02
- Acronym
- ASPIRE
- Status last verified
- Jan 2018
- First submitted
- 11 Feb 2013
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation
- ClinicalTrials.gov ID
- NCT01822093
- Acronym / sponsor ID
- ASPIRE / CM-2011-02
- Conditions
- ADV Infection Post Allo-HSCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cell Medica LtdIndustry (pharma, biotech, devices)
- Collaborators
- Technology Strategy Board, United Kingdom
- Study start
- Dec 2012
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytovir-ADV | Experimental | Biological: Cytovir-ADVAdenovirus-specific T-cells |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytovir-ADVAlso: Adenovirus-specific T-cellsA 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 | Biological | Cytovir-ADV |
Primary outcome
Number of subjects with new onset GVHD
Time frame: 180 days
number of subjects developing NCI Grade 3-4 adverse events
Time frame: 180 days
6 secondary outcomes
Number of reported Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs) and Suspected Expected Serious Adverse Reactions (SESARs)
Time frame: 180 days
Number of detectable HAdV-specific T-cells in vivo at each time point
Time frame: 180 days
Requirement for second infusion of HAdV-specific T-cells
Time frame: 180 days
Number of treatment days with antiviral drugs
Time frame: 180 days
Number of treatment days with other anti-infective drugs
Time frame: 180 days
Number of in-hospital days during 6 month post-infusion period
Time frame: 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waseem Qasim principal investigator
Institute of Child Health, London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cytovir-ADV in people with ADV Infection Post Allo-HSCT, run by Cell Medica Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with new onset GVHD (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.