Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Jan 14, 2020

Keywords

ClinConnect Summary

This clinical trial is researching a new treatment approach using special immune cells called viral specific T-lymphocytes (VSTs) to help prevent or treat viral infections in patients who have received a stem cell transplant from another person. After a stem cell transplant, patients often struggle with infections because their immune system is weakened, and current treatments can be complicated and costly. The goal of this study is to find out if giving these VSTs on a schedule can be more effective and less burdensome than the usual treatment when viral infections occur.

To participate in this study, patients need to be at least 21 days post-transplant and in stable health, allowing for a reduction in steroid medications. Eligible participants may include those with specific viral infections, like adenovirus, CMV, EBV, or BK virus, but they should not have severe complications related to their transplant or active cancer. Throughout the trial, participants will receive either the scheduled VST treatment or the usual treatment, and the research team will closely monitor their health and response to the therapy. This trial aims to improve the quality of life for patients recovering from stem cell transplants by exploring a potentially safer and more effective way to manage viral infections.

Gender

ALL

Eligibility 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