Trial document





This trial has been registered retrospectively.
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  DRKS00007890

Trial Description

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Title

Adoptive Aspergillus TH1-cell transfer in patients with probable or proven invasive Aspergillosis (IA) after haematopoietic stem
cell transplantation (HCT)

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Trial Acronym

TH1-ASP

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URL of the Trial

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Brief Summary in Lay Language

Evaluation of the safety and efficacy of Aspergillus-specific T-cell transfer in patients with invasive fungal infections caused by Aspergillus species after haematopoetic stem cell Transplantation; 28 patients shall be assessed in a multi-center Setting, primary endpoint is the incidence of graft-versus-host reactions (GvHD)

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Brief Summary in Scientific Language

Multi-center phase 1/2 trial to assess the safety and efficacy of adoptive TH1-cell transfer in patients with probable or proven invasive aspergillosis after haematopoietic stem cell transplantation.

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Organizational Data

  •   DRKS00007890
  •   2015/04/01
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  •   yes
  •   Approved
  •   190/13_ff, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  •   2013-002914-11 
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Health Condition or Problem studied

  •   B44 -  Aspergillosis
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Interventions/Observational Groups

  •   Patients receive one intravenous transfusion of T cells parallel with an antifungal therapy (e.g. voriconazole or liposomal amphotericin B, according to local standard of care for IA). Target dose: 0.5-3 x 10e3/kg RBW of donor-derived anti-Aspergillus T-cells, but a total of 5 x 103/kg RBW CD3 positive cells will not be exceeded. Total follow-up period 6 months per patient.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   I-II
  •   N/A
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Primary Outcome

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.

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Secondary Outcome

- 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)
- Surrogate markers of invasive aspergillosis (i.e., galactomannan)
- 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)
- Assessing the feasibility of the timely generation of donor-derived anti-Aspergillus T cells

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/11
  •   28
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum WürzburgMedizinische Klinik und Poliklinik II
    • Mr.  Prof. Dr.  Andrew J.  Ullmann 
    • Oberdürrbacher Str. 6
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum WürzburgMedizinische Klinik und Poliklinik II
    • Mr.  Prof. Dr.  Andrew J.  Ullmann 
    • Oberdürrbacher Str. 6
    • 97080  Würzburg
    • Germany
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Sources of Monetary or Material Support

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    • Bayerisches Immuntherapie Netzwerk (BayImmuNet)
    • 93053  Regensburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Josef-Schneider-Str.
    • 97080  Würzburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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