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 range
14 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.