Allogeneic Stell Cell TransplantPhase 2NCT04230356
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
A Phase 2 study testing Viral Specific T-cells (VSTs) Scheduled and Viral Specific T-cells (VSTs) Treatment in people with Allogeneic Stell 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 or treat 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 Stell Cell Transplant, Viral Infection
- What is being tested?
- Viral Specific T-cells (VSTs) Scheduled and Viral Specific T-cells (VSTs) Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 any steroids to < 0.5mg/kg prednisone or other steroid equivalent
- No critical illness making VST infusion hazardous
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 9,000
Show all 15Show fewer
- Plasma BKV PCR >1,000
- Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
- Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
- Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation.
- Evidence of symptomatic BK virus infection, defined as hemorrhagic cystitis or BK nephropathy.
- No active acute GVHD grades II-IV
- No uncontrolled relapse of malignancy
- No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
- Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
Who cannot join
- Active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy.
- Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. 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 scheduled VST infusion at that point.
- TREATMENT ARM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Celeste Dourson, MS, 513-636-7679, Celeste.Dourson@cchmc.org
Stella Davies, MBBS, PhD
About this study
Official title: A Randomized Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells (VSTs) for Control of Viral Infections After Allogeneic Stem Cell Transplant
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat 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 the body's 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 the investigators are trying to find a better way to treat these infections.
- Conditions
- Allogeneic Stell Cell Transplant, Viral Infection
- Being tested
- Viral Specific T-cells (VSTs) Scheduled, Viral Specific T-cells (VSTs) Treatment
- 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) ScheduledBiological
VSTs will be infused into stem cell transplant recipients on schedule.
Viral Specific T-cells (VSTs) TreatmentBiological
VSTs will be infused into stem cell transplant recipients only if viremia is detected.
| Study group | Role | What they receive |
|---|---|---|
| VSTs to Prevent | Experimental | VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection. Receives: Biological: Viral Specific T-cells (VSTs) Scheduled |
| VSTs to Treat | Experimental | VSTs will be given only if a viral infection develops. Receives: Biological: Viral Specific T-cells (VSTs) Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Failures
Treatment failure is defined as EBV>100,000, BKV >100,000, CMV >5,000 or Adv >50,000 at any time post randomization.
Measured: 21 - 100 days after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start27 Jan 2021
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stell 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
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
- Stella Davies, MBBS, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230356
- Sponsor's protocol ID
- 2019-1217
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2020
- Last updated
- 4 Sep 2026
- Results posted
- No
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells (VSTs) for Control of Viral Infections After Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT04230356
- Acronym / sponsor ID
- 2019-1217
- Conditions
- Allogeneic Stell Cell Transplant, Viral Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Hoxworth Blood Center
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Jan 2020 (actual)
- 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.
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat 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 the body's 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 the investigators are trying to find a better way to treat these infections.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSTs to Prevent | Experimental | Biological: Viral Specific T-cells (VSTs) ScheduledVSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection. |
| VSTs to Treat | Experimental | Biological: Viral Specific T-cells (VSTs) TreatmentVSTs will be given only if a viral infection develops. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
- No critical illness making VST infusion hazardous
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
Key exclusion criteria (4 listed)
- Active acute GVHD grades II-IV.
- Uncontrolled relapse of malignancy.
- Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. 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 scheduled VST infusion at that point.
- TREATMENT ARM
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) ScheduledVSTs will be infused into stem cell transplant recipients on schedule. | Biological | VSTs to Prevent |
| Viral Specific T-cells (VSTs) TreatmentVSTs will be infused into stem cell transplant recipients only if viremia is detected. | Biological | VSTs to Treat |
Primary outcome
Number of Treatment Failures
Time frame: 21 - 100 days after transplant
Treatment failure is defined as EBV>100,000, BKV >100,000, CMV >5,000 or Adv >50,000 at any time post randomization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
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.
Stella Davies, MBBS, PhD 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) Scheduled and Viral Specific T-cells (VSTs) Treatment in people with Allogeneic Stell 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 15 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jamie Wilhelm, BS (513-803-1102, Jamie.Wilhelm@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Treatment Failures (time frame: 21 - 100 days after transplant). 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 4 Sep 2026.