CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploident… (NCT07672964) | Clinical Trial Compass
Not Yet RecruitingPhase 1
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
China30 participantsStarted 2026-07-01
Plain-language summary
The goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. The main questions it aims to answer are:
Does this treatment lower the chance of getting serious viral infections after transplant? What medical problems do patients have when receiving this treatment?
Who can participate
Age range
14 Years – 50 Years
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:
Participants must meet all of the following criteria:
* Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed).
* Presence of at least one high-risk factor for post-transplant viral infection (any of the following):
* Age ≥50 years or ≤14 years
* Non-sibling matched transplantation
* In vivo or ex vivo T-cell depletion
* Myeloablative conditioning
* Conditioning containing radiotherapy
* Second transplantation
* CMV IgG or EBV IgG donor/recipient mismatch (donor positive, recipient negative)
* History of grade II or higher acute graft-versus-host disease (aGVHD) after transplantation and use of high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day)
* Availability of a suitable lymphocyte donor (see "Donor Selection Criteria").
* Adequate organ function meeting the following laboratory criteria:
* Liver function: ALT and AST ≤10× upper limit of normal (ULN); total bilirubin ≤5× ULN
* Renal function: BUN and creatinine ≤1.25× ULN
* No cardiac dysfunction on electrocardiogram or echocardiogram
* Pulmonary function: oxygen saturation \>90% without supplemental oxygen
* The patient or legal guardian has the desire and request to receive treatment, signs the informed consent form before treatment, and is willing to comply with the treatment plan, follow-up schedule, and laboratory tests.
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from this s…
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.
What they're measuring
1
Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI
Timeframe: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.