Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
China80 participantsStarted 2026-01-01
Plain-language summary
This clinical trial is designed as a single-arm, two-center, open-label, prospective study. All participants are enrolled in the standard-dose unrelated umbilical cord blood transplantation group to evaluate the efficacy and safety of unrelated umbilical cord blood transplantation in treating Epstein-Barr virus-associated lymphoproliferative disease.
Who can participate
Age range14 Years – 80 Years
SexALL
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Inclusion Criteria:General Inclusion Criteria:
All subjects must meet all of the following criteria:
Age range: 14 to 80 years old, inclusive.
Diagnosed with an EBV-associated lymphoproliferative disease (including Chronic Active EBV Infection, EBV-associated Hemophagocytic Lymphohistiocytosis, and EBV-associated Lymphoma).
Meet at least one of the following disease-specific criteria (see below).
ECOG Performance Status score of 0-2 (or Lansky Play-Performance score ≥60 for children).
Expected survival of ≥3 months.
Signed informed consent form (for minors, consent must be provided by a legal guardian).
Disease-Specific Inclusion Criteria:
A. CAEBV Patients: Patients diagnosed with CAEBV according to the 2016 revised WHO classification criteria, who also meet all of the following:
* Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months.
* Elevated EBV-DNA load in peripheral blood or involved tissues (peripheral blood EBV-DNA \> 500 copies/ml).
* Detection of EBV in T or NK cells (via EBER in situ hybridization or LMP1 immunohistochemistry).
* Exclusion of other known immunodeficiency disorders, autoimmune diseases, or neoplastic diseases.
B. EBV-HLH Patients: Meet ≥5 of the HLH-2004 diagnostic criteria:
* Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months.
* Fever ≥38.5°C.
* Splenomegaly.
* Cytopenias (affecting ≥2 of 3 lineages):
* Hb \<90 g/L
* PLT \<100 × 10⁹/L
* ANC \<1.0 × 10⁹/L
* Hypertriglyc…