RecruitingPhase 2ACTRN12613000603718

Phase I/II clinical trial to assess the safety and biological efficacy of treatment with virus-specific, cytotoxic T-lymphocytes from partially matched third-party unrelated donors, in stem cell transplant patients with viral reactivation unresponsive to standard therapy (R3ACT trial)

In allogeneic stem cell transplant patients, with viral reactivation unresponsive to standard antiviral therapy, is therapeutic infusion of most closely HLA-matched, third party, donor-derived, virus-specific cytotoxic T-lymphocytes, safe and efficacious?


Sponsor

Western Sydney Local Health Districit

Enrollment

30 participants

Start Date

Feb 11, 2013

Study Type

Interventional

Conditions

Summary

To assess the safety and efficacy of providing partially HLA matched, third party donor-derived, EBV/CMV/adenovirus-specific cytotoxic t-cells, to allogeneic stem cell/marrow transplant patients who have developed post-transplant viral infections unresponsive to standard therapy. It is hypothesised that virus-specific t-cells infusions will improve or restore the virus-specific immunity of the transplant patient in a safe manner without precipitating graft versus host disease.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is testing whether immune cells from a partially matched donor can be used to fight serious viral infections in people who have had a stem cell or bone marrow transplant. Transplant patients often develop infections with viruses like CMV, adenovirus, or EBV that do not respond to standard antiviral treatments. Researchers are testing whether infusing virus-fighting immune cells (called cytotoxic T-lymphocytes) from a donor bank can safely restore the patient's ability to fight these viruses. You may be eligible if: - You have received an allogeneic (from another person) stem cell or bone marrow transplant - You have a serious viral infection with CMV, adenovirus, or EBV that has not responded to standard treatment - Your liver and kidney function are at acceptable levels - Your performance status is ECOG 0–3 You may NOT be eligible if: - You received broad-spectrum anti-lymphocyte therapy in the past 4 weeks or have it planned in the next 4 weeks - You have Grade II or higher graft-versus-host disease - You are on high-dose steroids (prednisone above 1 mg/kg) within 72 hours of treatment - Your ECOG status is 4 (completely disabled) - You are privately insured (depending on the study site) Talk to your doctor about whether this trial might be right for you.

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

Treatment will consist of an initial infusion of 2 x 10^7/m^2 partially HLA-matched (minimum 1/6), third party, donor-derived, virus-specific (CMV, EBV, and/or adenovirus) cytotoxic T-lymphocytes. Up

Treatment will consist of an initial infusion of 2 x 10^7/m^2 partially HLA-matched (minimum 1/6), third party, donor-derived, virus-specific (CMV, EBV, and/or adenovirus) cytotoxic T-lymphocytes. Up to 3 subsequent infusions (with an option of increased dose up to 5 x 10^7/m^2) may be repeated at fortnightly intervals, on the basis of persistent viral reactivation.


Locations(15)

Westmead Hospital - Westmead

NSW,QLD,SA,VIC, Australia

Royal Perth Hospital - Perth

NSW,QLD,SA,VIC, Australia

Princess Margaret Hospital - Subiaco

NSW,QLD,SA,VIC, Australia

Royal Children's Hospital - Herston

NSW,QLD,SA,VIC, Australia

The Royal Childrens Hospital - Parkville

NSW,QLD,SA,VIC, Australia

Sydney Children's Hospital - Randwick

NSW,QLD,SA,VIC, Australia

The Alfred - Prahran

NSW,QLD,SA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,SA,VIC, Australia

Womens and Childrens Hospital - North Adelaide

NSW,QLD,SA,VIC, Australia

The Children's Hospital at Westmead - Westmead

NSW,QLD,SA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,SA,VIC, Australia

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,SA,VIC, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW,QLD,SA,VIC, Australia

Auckland, New Zealand

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ACTRN12613000603718