CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation

Korábbi kezelés

• Active aGVHD requiring prednisone or equivalent corticosteroid \>0.5 mg/kg/day

Más betegség

• Active grade II-IV acute graft-versus-host disease (aGVHD)
• Active viral infection
• Uncontrolled or relapsed malignancy

Laborértékek

• 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.

Egyéb

• Patients meeting any of the following criteria will be excluded from this study:

• 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.