Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Pati… (NCT04018261) | Clinical Trial Compass
CompletedPhase 1/2
Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients
Spain26 participantsStarted 2019-07-04
Plain-language summary
Marrow transplanted immunocompromised patients with cytomegalovirus (CMV) viral infection will be treated with CMV activated T-Lymphocytes. T-Lymphocytes will be obtained through an apheresis from a compatible donor.
Safety and immunoreconstitution parameters in blood samples will be assessed up to +60 days after the treatment.
Who can participate
Age range
1 Year
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
. Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
. Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
. Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
. Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia) It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn't decrease in \> 1 log in total blood or otherwise the absolute number of copies \> 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
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.
. Patients with reactivation of recurrent CMV despite correct anti-CMV treatment. It will be considered a recurrent CMV infection if the patient has \> 2 reactivations in a period \<6 months despite having received correct anti-CMV treatment
. Documented genetic mutations associated with ganciclovir or foscarnet resistance
. ≥ 1 year of age
. Estimated life expectancy \> 30 days
Exclusion criteria
. Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
. Corticosteroid ≥ 0.5mg/kg regardless the indication
. Disease relapse at the time of infection or at any time after the Allogeneic transplant.
. Severe renal disease (creatinine \> 3gr/dL)
. Severe hepatic disease (bilirubin \>3mg/dL or aspartate aminotransferase (AST) \>500 U/L) except if it is secondary to the viral infection.
. Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.
. Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
. Known hypersensitivity to murine proteins or iron dextran.