T lymphocytes for the Treatment of AdV, CMV, EBV, BKV and Aspergillus fumigatus infections after allogeneic stem cell transplantatio
- Conditions
- Hematopoietic stem cell transplant (HSCT) recipients with AdV, EBV, CMV, BKV or Aspergillus fumigatus (AF) infection/ reactivation or with active disease.Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-004725-23-GR
- Lead Sponsor
- Ge???? ??s???µe?? Tessa??????? Ge?????? ?apa????????
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
1)Received prior myeoloablative or nonmyeloablative allogeneic hematopoietic stem cell transplant.
2)Cells administered as treatment for single or multiple infections/reactivations of one or more of the following pathogens: AdV, CMV, EBV, ??V and AF (see 2.2.1 definitions).
3)Karnofsky/Lansky score of = 50.
4)ANC > 500/µl.
5)Bilirubin = 2x*, AST < 3x*, Serum creatinine = 2x*, Hemoglobin > 8.0 g/dl.
6)Pulse oximetry of > 90% on room air.
7)Available pentavalent-specific T cells.
8)Negative pregnancy test (if female of childbearing potential)
9)Patient capable of providing informed consent.
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1)Received ATG, or Campath or other T cell immunosuppressive monoclonal antibodies in the last 28 days.
2)Steroids > 0.5 mg/kg/day prednisone.
3)Received donor lymphocyte infusion in last 28 days.
4)GVHD = grade 2.
5)Active and uncontrolled relapse of malignancy.
6)Patients with other uncontrolled infections
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method