Infectious Complications Following HSCTEPROSNCT02873325
Registry on Salvage Antiviral Treatment for Patients Experiencing ADV and / or CMV Reactivation Post Allogeneic HSCT
An observational study of Infectious Complications Following HSCT, run by Cell Medica Ltd at 2 sites in United Kingdom.
Trial summary
DESIGN: Disease registry - non-interventional. INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infectious Complications Following HSCT
- What is being tested?
- antiviral therapies for CMV and/or ADV
- How many people
- 1 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 May 2016to 23 Feb 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and/or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy.
- Written informed consent
- Physician requested salvage (defined as refractory to first, requirement for second line or greater) treatment for ADV and / or CMV reactivation post allogeneic HSCT.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Birmigham Children Hospital
Birmingham
Bristol Royal Hospital For Children
Bristol
About this study
Official title: European Patient Registry on Salvage Antiviral Treatment for Patients Experiencing Adenovirus and / or Cytomegalovirus Reactivation Post Allogeneic Hematopoietic Stem Cell Transplantation
DESIGN:
Disease registry - non-interventional.
INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.
Read the detailed description
In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and / or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.
- Conditions
- Infectious Complications Following HSCT
- Being tested
- antiviral therapies for CMV and/or ADV
- Keywords
- ADV, CMV, HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiviral therapies for CMV and/or ADVOther
salvage antiviral treatments for ADV and/or CMV
What is being measured
The primary outcome is the main question the study is designed to answer.
ADV and/or CMV reactivations
assessment of ADV/CMV viral clearance to evaluate the efficacy of salvage therapies for ADV and / or CMV infections post allogeneic HSCT
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study start11 May 2016
- Primary completion23 Feb 2017
- Study completion23 Feb 2017
Why it stopped: Lack of study recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Complications Following 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cell Medica Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prashant Hiwarkar, Principal investigator, Birmingham Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873325
- Sponsor's protocol ID
- CM-2016-01
- Acronym
- EPROS
- Status last verified
- Jan 2018
- First submitted
- 21 Oct 2015
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Patient Registry on Salvage Antiviral Treatment for Patients Experiencing Adenovirus and / or Cytomegalovirus Reactivation Post Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT02873325
- Acronym / sponsor ID
- EPROS / CM-2016-01
- Conditions
- Infectious Complications Following HSCT
- Keywords
- ADV, CMV, HSCT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of study recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Cell Medica LtdIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 23 Feb 2017 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 19 Aug 2016 (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.
DESIGN:
Disease registry - non-interventional.
INDICATION: Patients failing first or subsequent line treatment for adenovirus and / or cytomegalovirus reactivation post allogeneic hematopoietic stem cell transplantation.
Detailed description
In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and / or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy. The patients will be consented prospectively or retrospectively for collection of data. Data will be collected at baseline, 6 months and 1 year after commencement of salvage treatment. Retrospective data collection (for patients who underwent HSCT in 2010 or later) is permitted.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In this disease registry, data on approximately 120 allo HSCT patients who have received salvage treatment (second or later line) with any antiviral therapy for ADV and/or CMV post allogeneic HSCT will be documented; of these 120, at least 40 patients will have been treated with Cell Medica's immune reconstitution ACT as salvage therapy.
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 |
|---|---|---|
| antiviral therapies for CMV and/or ADVsalvage antiviral treatments for ADV and/or CMV | Other | – |
Primary outcome
ADV and/or CMV reactivations
Time frame: 12 months
assessment of ADV/CMV viral clearance to evaluate the efficacy of salvage therapies for ADV and / or CMV infections post allogeneic HSCT
Results and safety
The study was stopped early (reason given: Lack of study recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: Yes
Related trials for Infectious Complications Following HSCT
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection
RecruitingPhase 3
Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
AdV Infection, EBV Infection
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.
Prashant Hiwarkar principal investigator
Birmingham Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Complications Following HSCT, run by Cell Medica Ltd at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
The study was stopped early (reason given: Lack of study recruitment). Results are not available in the source record.
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?
ADV and/or CMV reactivations (time frame: 12 months). 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 1 Feb 2018.