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NCT07672964
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
Conditions: Hematologic Malignancy, Haplo-identical HCT
Sex: All
Ages: 14 Years – 50 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Ruijin Hospital
Location: Ruijin Hospital Shanghai SH
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?
Eligibility Criteria
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 study:
* Active grade II-IV acute graft-versus-host disease (aGVHD)
* Active aGVHD requiring prednisone or equivalent corticosteroid \>0.5 mg/kg/day
* Active viral infection
* Uncontrolled or relapsed malignancy
* Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.
Source: ClinicalTrials.gov (NCT07672964). StuddyBuddy aggregates publicly available trial information.