Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/23/2019 |
| Start Date: | March 2019 |
| End Date: | March 2024 |
| Contact: | Celeste Dourson, MS |
| Email: | Celeste.Dourson@cchmc.org |
| Phone: | (513) 636-7679 |
The purpose of this research study is to learn more about the use of viral specific
T-lymphocytes (VSTs) to prevent 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 your 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 we are trying to find a way to
prevent these infections.
T-lymphocytes (VSTs) to prevent 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 your 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 we are trying to find a way to
prevent these infections.
Inclusion Criteria:
- Recipient must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other
steroid equivalent
Exclusion Criteria:
- Patients who have developed viral infection or reactivation will be ineligible for
prophylactic infusions of VSTs
- Active acute GVHD grades II-IV
- Uncontrolled relapse of malignancy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion. Additionally, in
patients who received alemtuzumab as part of their conditioning regimen, alemtuzumab
levels will be collected in the second week following stem cell infusion. 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 prophylactic VST infusion at that point if
there is still no evidence of viral infection at that time.
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Michael Grimley, MD
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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