Using donor-derived T-cells to fight viral infections after stem cell transplant
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
This study is testing whether using special immune cells from donors can help prevent or treat viral infections in people who have had a stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Drugs / interventions | alemtuzumab, prednisone |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT04230356 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of donor-derived viral specific T-lymphocytes (VSTs) in preventing or treating viral infections that can occur after an allogeneic stem cell transplant. The study compares two approaches: scheduled administration of VSTs versus treatment administration based on the presence of viral infections. By utilizing VSTs, the trial aims to reduce the complications and costs associated with traditional antiviral treatments, which can be burdensome for patients and their families. The study is designed to assess the safety and efficacy of this innovative approach in a Phase 2 setting.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have undergone an allogeneic stem cell transplant and are experiencing viral infections or are at risk of developing them.
Not a fit: Patients with active acute graft-versus-host disease (GVHD) or uncontrolled malignancy relapse may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective and less burdensome treatment option for patients suffering from viral infections after stem cell transplant.
How similar studies have performed: While the use of viral specific T-cells is a promising approach, the success of similar studies is still being evaluated, making this a novel and potentially groundbreaking intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
SCHEDULED ARM: 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 this trial is running
Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Stella Davies, MBBS, PhD — Children's Hospital Medical Center, Cincinnati
- Study coordinator: Celeste Dourson, MS
- Email: Celeste.Dourson@cchmc.org
- Phone: 513-636-7679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.