A randomised trial of third-party virus-specific T cells in patients with untreated viral infection after an allogeneic stem cell transplantation
A randomised trial of most closely HLA-matched third-party donor-derived virus-specific cytotoxic T-lymphocytes in patients with untreated viral infection post-allogeneic stem cell transplantation to reduce number of days in hospital
Western Sydney Local Health District
144 participants
Jan 18, 2021
Interventional
Conditions
Summary
The study will involve patients who have a CMV or EBV infection requiring treatment following allogeneic blood or marrow transplantation. Patients with CMV or EBV requiring therapy will be randomly allocated to receive best available therapy or to best available therapy plus infusions of immune cells directed at CMV and EBV. The aim of the study is to assess whether the combination of best available therapy and immune cells improved the outcomes for patients.
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
1 to 4 sequential intravenous infusions of 2x10^7/m^2 Tcells directed at each CMV and EBV. Hence, the total dose is 4x10^7/m^2 Tcells. Patients randomised to receive investigational product will receive at least 1 infusion. Patients will be assessed for eligibility for subsequent infusions after 21 days post each infusion. Patients will be eligible for a subsequent infusion if the CMV virus titre is >1000IU/ml blood or EBV virus titre is 5000 copies/ml blood or if there is ongoing clinical and/or radiological and/or virological infection in the organ system(S) affected by the virus that led to the initial infection. EBV associated post-transplant lymphoproliferative disease (PTLD) will also deem a patient eligible. If the patient is eligible, they will receive a subsequent infusion at the same dose. A total of 4 infusions may be given to any one patient randomised to the investigational product arm. If a patient requires additional doses, they will be contacted to arrange suitable appointment times. Infusions will be documented in medical records.
Locations(6)
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ACTRN12620000171910