CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation

Korábbi kezelés

• Prednisone or equivalent corticosteroid dose > 0.5 mg/kg/day.
• Receipt of anti-thymocyte globulin (ATG), alemtuzumab (Campath), or other T-cell immunosuppressive monoclonal antibodies within 28 days before enrollment.

Más betegség

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

Laborértékek

• Less than 28 days after allogeneic transplantation, or receipt of donor lymphocyte infusion (DLI) or virus-specific T cell (VST) therapy within 28 days before enrollment.
• Presence of other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or that may interfere with informed consent, study participation, follow-up, or interpretation of study results.

Egyéb

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

• Participants must meet all of the following criteria:
• Patients who have undergone hematopoietic stem cell transplantation.
• Presence of viremia and/or viral infection-related disease caused by a single virus or multiple viruses among the following: CMV, EBV, ADV, BK, B19, JC, HHV-6B, HSV1, or HSV2.
• Patients who, after ≥2 weeks of first-line therapy, have persistent viral positivity, no relief or worsening of clinical symptoms, or re-infection with the same pathogen after viral clearance.
• Availability of a suitable lymphocyte donor.
• Adequate organ function, meeting the following laboratory criteria:
• Liver function: ALT and AST ≤ 10 × upper limit of normal (ULN), TBIL ≤ 5 × ULN.
• Renal function: BUN and Cr ≤ 1.25 × ULN.
• No cardiac insufficiency on electrocardiogram (ECG) or echocardiogram.
• Pulmonary function: oxygen saturation > 90% on room air.
• Willingness and ability of the patient or their legal guardian to receive treatment, comply with the treatment plan, follow-up schedule, and laboratory examinations, and provision of signed informed consent before any study-specific procedure.