Allogeneic Stem Cell TransplantPhase 2NCT03883906
Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
A Phase 2 study testing Viral Specific T-cells (VSTs) in people with Allogeneic Stem Cell Transplant and Viral Infection, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allogeneic Stem Cell Transplant, Viral Infection
- What is being tested?
- Viral Specific T-cells (VSTs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2019to 1 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
Who cannot join
- Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs
- Active acute GVHD grades II-IV
- Uncontrolled relapse of malignancy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. The level must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).
Stem cell transplant reduces your ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study we are trying to find a way to prevent these infections.
- Conditions
- Allogeneic Stem Cell Transplant, Viral Infection
- Being tested
- Viral Specific T-cells (VSTs)
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral Specific T-cells (VSTs)Biological
VSTs will be infused into stem cell transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| Viral Specific T-cells (VSTs) | Experimental | Not described Receives: Biological: Viral Specific T-cells (VSTs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Presence of a Toxicity
Participants will be assessed for the presence of a toxicity.
Measured: 30 days
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)
Participants will be assessed for the presence of aGVHD.
Measured: 30 days
Secondary outcomes (1)
Number of Participants With Presence of a Viral Infection
Participants will be assessed for the presence of viral infection.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start16 Mar 2019
- Primary completion31 Oct 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allogeneic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Hoxworth Blood Center
- Responsible party
- Sponsor
- Investigators
- Michael Grimley, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883906
- Sponsor's protocol ID
- 2019-0229
- Status last verified
- Nov 2022
- First submitted
- 19 Mar 2019
- Last updated
- 13 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03883906
- Acronym / sponsor ID
- 2019-0229
- Conditions
- Allogeneic Stem Cell Transplant, Viral Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Hoxworth Blood Center
- Study start
- 16 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 13 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).
Stem cell transplant reduces your ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study we are trying to find a way to prevent these infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viral Specific T-cells (VSTs) | Experimental | Biological: Viral Specific T-cells (VSTs) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
Key exclusion criteria (4 listed)
- Patients who have developed viral infection or reactivation will be ineligible for prophylactic infusions of VSTs
- Active acute GVHD grades II-IV
- Uncontrolled relapse of malignancy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab levels will be collected in the second week following stem cell infusion. The level must be less than, or equal to, 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for prophylactic VST infusion at that point if there is still no evidence of viral infection at that time.
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 |
|---|---|---|
| Viral Specific T-cells (VSTs)VSTs will be infused into stem cell transplant recipients | Biological | Viral Specific T-cells (VSTs) |
Primary outcome
Number of Participants With Presence of a Toxicity
Time frame: 30 days
Participants will be assessed for the presence of a toxicity.
Number of Participants With Acute Graft-Vs-Host Disease (aGVHD)
Time frame: 30 days
Participants will be assessed for the presence of aGVHD.
1 secondary outcome
Number of Participants With Presence of a Viral Infection
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Grimley, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viral Specific T-cells (VSTs) in people with Allogeneic Stem Cell Transplant and Viral Infection, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 2 inclusion and 4 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 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 13 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Presence of a Toxicity (time frame: 30 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 13 Dec 2022.