Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
A Single-arm, Two-center, Prospective Clinical Study of Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
Fudan University
80 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria29
- 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).
- 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
- Hypertriglyceridemia (\>3 mmol/L) and/or hypofibrinogenemia (\<1.5 g/L).
- Serum ferritin \>500 μg/L.
- sCD25 \>2400 U/mL.
- Decreased or absent NK cell activity.
- Evidence of hemophagocytosis in bone marrow, spleen, or lymph nodes.
- C. EBV-associated Lymphoma Patients:
- Pathologically confirmed diagnosis according to WHO criteria.
- EBV-positive (EBER+).
- Failure of or relapse after first-line therapy.
Exclusion Criteria18
- History of another primary malignancy within 5 years prior to the first treatment.
- Uncorrected thyroid dysfunction.
- Grade II or higher cardiac disease according to the New York Heart Association (NYHA) classification.
- History of organ transplantation.
- Planned to receive other types of hematopoietic stem cell transplantation during the study period.
- Active infections, including:
- Active hepatitis B or hepatitis C.
- Positive serum HIV antigen or antibody.
- History of syphilis.
- Major surgery within 4 weeks prior to the first treatment, or anticipated need for major surgery during the study.
- Pregnant or breastfeeding women.
- History of severe psychiatric illness or substance abuse.
- High risk of complications, such as:
- Uncontrolled infection.
- Active major visceral hemorrhage.
- Known allergy to any component of the investigational drug(s), or a history of severe allergies.
- Patients deemed unable to comply with the study procedures and/or follow-up requirements.
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Interventions
All participants will be enrolled in the treatment group and will receive a standard-dose unrelated cord blood transplantation. The efficacy and safety of unrelated cord blood transplantation for the treatment of Epstein-Barr virus-associated lymphoproliferative diseases will be evaluated.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07381738