Probable or proven pulmonary or sinus aspergillosis by the 2008 EORTC/MSG criteria Patients after allogeneic HCT
Conditions
Interventions
Product Name: donor derived anti-Aspergillus T cells
Pharmaceutical Form: Solution for infusion
Sponsors
Universitätsklinikum der Julius-Maximilians Universität Würzburg A.ö.R.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients after allogeneic HCT • Remission of the underlying malignancy • Probable or proven pulmonary or sinus aspergillosis by the 2008 EORTC/MSG criteria • In a first step a minimum age: > 18 year of age, after a preliminary evaluation (after review of 4 patients by the safety board, study will continue and is planned to include children (ADDITION APPLICATION WILL APPLY)) • Life expectancy: > 7 days Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • CNS-aspergillosis (suspected, probable or proven) • Active greater acute GvHD >2° or chronic extensive GvHD requiring prednisolone-equivalent > 2 mg/kg • Triazole and amphotericin B intolerance • Campath or ATG 4 weeks prior to enrolment • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing the safety and tolerability of adoptive immune therapy with donor-derived anti-Aspergillus T-cells in patients diagnosed with invasive aspergillosis.;Secondary Objective: Assessing the efficacy of adoptive immune therapy with donor-derived anti-Aspergillus T-cells in patients diagnosed with invasive aspergillosis.;Primary end point(s): Primary endpoint: Incidence of occurrence of any GvHD;Timepoint(s) of evaluation of this end point: Screening d0 week +1 week +2 week +3 week +6 week +9 week +12 week +16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidences of transfusion-related adverse events • Response rate to antifungal therapy by favourable outcome (PR and CR), stable disease (SD), and unfavourable outcome (PD) • Mortality (overall and IFD attributable);Timepoint(s) of evaluation of this end point: d0 week +1 week +2 week +3 week +6 week +9 week +12 week +16 | — |
Countries
Germany
Contacts
Public ContactMedizinische Klinik II
Universitätsklinikum der Julius-Maximilians Universität Würzburg A.ö.R.
Outcome results
None listed