IMMUNE THERAPY FOR PATIENTS WITH MOLD DISEASE AFTER HAEMATOPOIETIC STEM CELL TRANSPLANTATION (HCT)

• Conditions: Probable or proven pulmonary or sinus aspergillosis by the 2008EORTC/MSG criteriaPatients after allogeneic HCT; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-002914-11-DE
• Lead Sponsor: niversitätsklinikum der Julius-Maximilians Universität Würzburg A.ö.R.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-14
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>d0<br>week +1<br>week +2<br>week +3<br>week +6<br>week +9<br>week +12<br>week +16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Incidences of transfusion-related adverse events<br>• Response rate to antifungal therapy by favourable outcome (PR and CR), stable disease (SD), and unfavourable outcome (PD)<br>• Mortality (overall and IFD attributable);Timepoint(s) of evaluation of this end point: d0<br>week +1<br>week +2<br>week +3<br>week +6<br>week +9<br>week +12<br>week +16