RecruitingPhase 2ACTRN12620000171910

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


Sponsor

Western Sydney Local Health District

Enrollment

144 participants

Start Date

Jan 18, 2021

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After a bone marrow or stem cell transplant, the immune system is temporarily very weak. Two viruses — CMV (cytomegalovirus) and EBV (Epstein-Barr virus) — can reactivate during this period and become dangerous. While antiviral medications exist, they don't always work well enough on their own. This study is testing whether adding a specially prepared infusion of immune cells (called virus-specific T cells, donated from healthy third-party donors) to the standard antiviral treatment helps patients fight these infections more effectively. Participants are randomly assigned to receive either standard treatment alone or standard treatment plus the immune cell infusion. You may be eligible if you have had an allogeneic stem cell transplant within the past six months and have developed a CMV or EBV infection that requires treatment. You must be well enough to participate and not be experiencing severe graft-versus-host disease at the time of the infusion. This trial is running in Australian hospitals and aims to improve outcomes for transplant patients facing these challenging viral infections.

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 rece

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)

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,WA,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,QLD,WA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,WA,VIC, Australia

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ACTRN12620000171910