Allogeneic hematopoietic stem cell transplantation (HSCT) patients considered at high risk of developing adenovirus (ADV) infection Infections and Infestations Other transplanted organ and tissue status
Conditions
Interventions
Current interventions as of 28/04/2015:
Adenovirus-specific T-cells (Cytovir-ADV)
A single dose 1x10e4 CD3+ T cells/kg patient weight of Cytovir ADV is prescribed to p
Sponsors
Cell Medica Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Age 16 years or younger 2. Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor 3. The subject (or legally acceptable representative) must give informed consent (and assent for subjects = 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent 4. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG. Donors (for manufacturing only): 1. Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein 2. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG 3. Passed medical assessment for stem cell donation 4. HdADV seropositive 5. Signed informed consent 6. Age 16 years or older
Exclusion criteria
Exclusion criteria: Patients 1. Pregnant or lactating females 2. Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae 3. Human Immunodeficiency Virus (HIV) infection Donors 1. Pregnant or lactating females 2. (assessed prior to apheresis) Platelets < 50x109/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/04/2015: 1. Number of subjects with new onset GvHD; Time Frame: 180 days 2. Number of subjects developing NCI Grade 3-4 adverse events; Time Frame: 180 days Previous primary outcome measures: 1. Toxicity 2. Incidence and severity of GVHD 3. Cytopenias 4. Grade 3-4 adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of reported serious adverse events (SAEs) (Suspected, Unexpected Serious Adverse Reactions [SUSARs] and Suspected, Expected Serious Adverse Reactions [SESARs]) 2. Number of detectable HAdV-specific T-cells in vivo at each time point 3. Requirement for second infusion of ADV specific T cells 4. Number of treatment days with antiviral drugs. 5. Number of treatment days with other anti-infective drugs 6. Number of in-hospital days during study period | — |
Countries
United Kingdom
Outcome results
None listed