Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial
- Conditions
- virus diseasesvirus infections10047438
- Registration Number
- NL-OMON54824
- Lead Sponsor
- Klinikum der Universität München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1. Adult or paediatric patients (>2 months of age) after HSCT suffering from
new or reactivated CMV or EBV or AdV infection, refractory to standard
antiviral treatment for two weeks (defined as <=1 log decrease in viral load
over two weeks) as confirmed by quantitative blood PCR analysis
2. Original HSCT-donor available with an immune response at least to the virus
causing the therapy-refractory infection
3. Written informed consent given (patient or legal representative)
1. Acute GvHD > grade II or extensive chronic GvHD at time of T-cell transfer
2. Treatment with steroids (>1 mg/kg Prednisone equivalent) at Screening
3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP
infusion until 8 weeks post IMP infusion. In case of T-cell depleted HSCT, a
prescheduled prophylactic DLI <=3 x 10e5 T cells/kg BW is not considered an
exclusion criteria.
4. Organ dysfunction or failure as determined by Karnofsky (age >16 years) or
Lansky (age <=16 years) score <=30%
5. Concomitant enrolment in another clinical trial interfering with the
endpoints of this study
6. Any medical condition which could compromise participation in the study
according to the investigator*s assessment
7. Progression of underlying disease (disease that has led to the indication of
HSCT, e.g. leukemia) that will limit the life expectance below the duration of
the study
8. Second line or experimental antiviral treatment other than
Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening
until 8 weeks after IMP infusion
9. Known HIV infection. In case patients do not have a negative HIV test
performed within 6 months before enrolment in the study, HIV negativity has to
be confirmed by a negative laboratory test.
10. Female patient who is pregnant or breast-feeding, or adult of reproductive
potential not willing to use an effective method of birth control from
Screening until the last follow-up visit (FU6, visit 8) Note: women of
childbearing potential must have a negative serum pregnancy test at study entry
11. Known hypersensitivity to iron dextran
12. Patients unwilling or unable to comply with the protocol or unable to give
informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Percentage of patients with viral clearance (defined as two consecutive<br /><br>negative PCRs)<br /><br>Percentage of patients with progression between Day 7 and Week 8 after T-cell<br /><br>transfer</p><br>
- Secondary Outcome Measures
Name Time Method