EUCTR2013-002492-17-AT
Active, not recruiting
Phase 1
Treatment of adenovirus and cytomegalovirus infection post human allogeneic stem cell transplantation with short-term expanded virus-specific T cells - VIsIT
ConditionsPatients undergoing allogeneic HSCT undergo weekly screening for HAdV and CMV PCR. In case of viraemia = 100 copies/ml PB preemptive antiviral with either Gancyclovir or Cidofovir conform to the local HSCT-infection-SOPs. In case of increasing viral load despite adequte virostatic treatment for two weeks, the administration of donor derived (or receipient derived in case of donor CMV negativity and receipient positivity before HSCT) virus specific T cells is foreseenMedDRA version: 18.1 Level: LLT Classification code 10050541 Term: Cytomegalovirus antigen positive System Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 30
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •Children and adolescents (0\-18 years) who undergo any type of allogeneic stem cell transplantation at the St Anna Children\`s Hospital, Vienna.
- •Informed consent is signed
- •Presence of HAdV or CMV\-specific T\-cells in the donor or CMV\-specific T\-cells in the recipient pre\-transplant
- •Stable (\= 10E6\) or increasing viraemia despite antiviral treatment post HSCT
- •Absence of virus\-specific T cells post transplant
- •Karnofsky / Lansky score \>50%
- •Pregnancy excluded
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Infusion of polyclonal or monoclonal T\-cell directed antibodies within 28 days before seVirus T\-Cell infusion
- •Multiple organ failure at screening\-timepoint seVirus T\-Cell infusion
- •History of GvHD Gr III\-IV or actual GvHD Gr III\-IV
- •Treatment with granulocyte transfusion within the last 72 hours
- •Karnofsky / Lansky score \<50%
- •Subject is unwilling or unable to comply with the study procedures
- •High dose treatment with steroids (\= 2mg/kg/d, methylprednisone\-equivalent)
Investigators
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Phase 1
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