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Compares treatment options for AdV Infection
Official title Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections
ClinicalTrials.gov ID: NCT04832607
What this study is testing
- What it's testing
- Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- Adult or paediatric patients (\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or...
- Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.
- Written informed consent given (patient or legal representative) prior to any study-related procedures.
You likely can't join if
- Patient with acute GvHD \> grade II or extensive chronic GvHD at the time of IMP transfer
- Patient receiving steroids (\>1 mg/kg BW Prednisone equivalent) at Screening.
- Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105...
- Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
- Concomitant enrolment in another clinical trial interfering with the endpoints of this study
- Any medical condition which could compromise participation in the study according to the investigator's assessment
See the full eligibility criteria
- Adult or paediatric patients (\> 2 months of age) after allogeneic stem cell transplantation (SCT) (no time restrictions apply) suffering from new or reactivated CMV or EBV or AdV infection refractory to standard...
- Original HSCT-donor available with an immune response at least to the virus causing the therapy-refractory (=underlying) infection.
- Written informed consent given (patient or legal representative) prior to any study-related procedures.
- Patient with acute GvHD \> grade II or extensive chronic GvHD at the time of IMP transfer
- Patient receiving steroids (\>1 mg/kg BW Prednisone equivalent) at Screening.
- Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion. Prescheduled prophylactic DLI ≤3x105 T cells/kg BW in case of T-cell depleted HSCT is not considered an...
- Patient with organ dysfunction or failure as determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
- Concomitant enrolment in another clinical trial interfering with the endpoints of this study
- Any medical condition which could compromise participation in the study according to the investigator's assessment
- Progression of underlying disease (disease that has led to the indication of HSCT, e.g. leukaemia) that will limit the life expectance below the duration of the study
- Second line or experimental antiviral treatment other than Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab until 8 weeks after IMP Infusion or prophylactic Treatment other than Aciclovir or Letermovir...
- 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.
- Female patient who is pregnant or breast-feeding. Female patient of child-bearing potential (i.e. post menarche and not surgically sterilized) or male patient of reproductive potential not willing to use an effective...
- Known hypersensitivity to iron dextran
- Patients unwilling or unable to comply with the protocol or unable to give informed consent.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Lille, France
- Lyon, France
- Nancy, France
- Paris, France
- Berlin, Germany
- Dresden, Germany
- Düsseldorf, Germany
- Essen, Germany
- Freiburg im Breisgau, Germany
- Hanover, Germany
- Leipzig, Germany
- Munich, Germany
- München, Germany
- Regensburg, Germany
- Tübingen, Germany
- Würzburg, Germany
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Liège, Belgium; Lille, France; Lyon, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.