Adoptive Aspergillus TH1-cell transfer in patients with probable or proven invasive Aspergillosis (IA) after haematopoietic stemcell transplantation (HCT)
Phase 1
Recruiting
- Conditions
- B44Aspergillosis
- Registration Number
- DRKS00007890
- Lead Sponsor
- niversitätsklinikum Würzburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Female or male patients after allogeneic HCT
- Remission of the underlying malignancy
- Probable or proven pulmonary or sinus aspergillosis defined by the 2008
EORTC/MSG criteria
- Minimum age: > 18 year of age
- Live expectancy: > 7 days
- Not legally incapacitated
- Written informed consent from the trial subject has been obtained
Exclusion Criteria
- CNS-aspergillosis (suspected, probable or proven)
- Active greater acute GvHD >2° or chronic extensive GvHD requiring prednisolone-equivalent > 2 mg/kg
- Dextran-containing products, triazole and amphotericin B intolerance
- Campath or ATG 4 weeks prior to enrolment
- Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of occurence of any GvHD. Acute GvHD is documented according to the modified Seattle Glucksberg criteria (also termed the Consensus criteria) for grading of acute GvHD. Staging of chronic GVHD is performed using a standardized staging form of the German-Austrian-Swiss Consortium for GvHD. 10 visits within 6 months after T-cell therapy.
- Secondary Outcome Measures
Name Time Method - 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)<br>- Surrogate markers of invasive aspergillosis (i.e., galactomannan)<br>- Assessing the general (i.e. CD3, CD4 and CD8 counts) and specific immune reconstitution regarding various infectious diseases (i.e. Aspergillus-specific, CMV and EBV)<br>- Assessing the feasibility of the timely generation of donor-derived anti-Aspergillus T cells<br>