Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
Status and phase
Conditions
Treatments
Details and patient eligibility
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).
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.
Enrollment
Sex
Volunteers
Inclusion and 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
180 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Jamie Wilhelm, BS; Celeste Dourson, MS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal