Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus (NCT01325636) | Clinical Trial Compass
CompletedPhase 1/2
Injection of CD4 and CD8 + T Cells Anti-Cytomegalovirus (CMV) or Anti-adenovirus
France16 participantsStarted 2010-09
Plain-language summary
The main purpose of this project is to evaluate the efficiency of the injection of CD4 and CD8+ T cell anti-Cytomegalovirus (CMV) on blood viral replication of CMV, 21 days after the first injection (adenovirus infection is not enough usual, especially in adults, to be used for the primary purpose and is measured in the secondary endpoints).
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child or adult patient (without age limit) treated by allogenic haematopoietic stem cell transplant whatever underlying pathology with a donor chimerism ≥ 10 %, at the time of the inclusion and :
* having biological signs (blood viral load) associated or not with clinical signs of infection by CMV and / or resistant or intolerant Adenovirus (myelotoxicity or nephrotoxicity) to a conventional antiviral treatment
* or with CMV or ADV disease with organ damage documented without systemic replication (if possible, with a CMV PCR or ADV PCR positive in the organ)
* without GvHa at the time of the inclusion or GvHa ≤ II controlled by Corticoids \< 1mg / Kg (but corticosteroids on decrease) or cyclosporine only. A possible treatment by monoclonal antibody anti r-IL2 (LEUCOTAC) must have been interrupted for at least 8 days. The preventive treatment of the GvHa by cyclosporine or mycophenolate mofetil is compatible with the study
* answering to eligibility criteria for the donor (in particular donor CMV positive serology and absence of intercurrent infections)
* having been informed - he or his legal representative - and having signed the informed consent
* patient member or benefiting from a social security scheme
Exclusion Criteria:
* donor CMV negative serology (in the case of anti-CMV immunotherapy). Note : all donors are considered as having met the adenovirus and the status serology towards this virus, will not be checked.
* GvHa \> II and/or requiring …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.