NCT04230356 · Children's Hospital Medical Center, Cincinnati
Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
What this study is about
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).
View original scientific description
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.
Interventions
BIOLOGICAL
Viral Specific T-cells (VSTs) Scheduled
VSTs will be infused into stem cell transplant recipients on schedule.
BIOLOGICAL
Viral Specific T-cells (VSTs) Treatment
VSTs will be infused into stem cell transplant recipients only if viremia is detected.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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 Inclusion Criteria:
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 9,000
- 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
Where
- Cincinnati, Ohio
Collaborators
Hoxworth Blood Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 12, 2026 · Source of record for eligibility and locations