Actively Recruiting
Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
Led by Fudan University · Updated on 2026-02-02
80
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
H
Huashan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 14 and 80 years inclusive
- Diagnosed with an EBV-associated lymphoproliferative disease including CAEBV, EBV-associated HLH, or EBV-associated lymphoma
- For CAEBV: persistent infectious mononucleosis-like symptoms >3 months, elevated EBV-DNA >500 copies/ml, EBV detected in T or NK cells, no other immunodeficiency or neoplastic diseases
- For EBV-HLH: meet at least 5 HLH-2004 criteria including fever ≥38.5°C, splenomegaly, cytopenias affecting at least 2 cell lines, hypertriglyceridemia or hypofibrinogenemia, elevated ferritin, high sCD25, decreased NK cell activity, or hemophagocytosis evidence
- For EBV-associated lymphoma: pathologically confirmed EBV-positive lymphoma, relapsed or refractory after first-line therapy
- ECOG Performance Status 0-2 or Lansky score ≥60 for children
- Expected survival of 3 months or more
- Signed informed consent (parent or guardian consent for minors)
You will not qualify if you...
- History of another primary cancer within 5 years
- Uncorrected thyroid dysfunction
- NYHA grade II or higher cardiac disease
- History of organ transplantation
- Planned to receive other hematopoietic stem cell transplant types during the study
- Active infections including hepatitis B, hepatitis C, HIV, or syphilis
- Major surgery within 4 weeks before first treatment or planned during study
- Pregnant or breastfeeding women
- Severe psychiatric illness or substance abuse history
- High risk of complications like uncontrolled infection or major visceral hemorrhage
- Allergy to study drugs or history of severe allergies
- Unable to comply with study procedures or follow-up
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Huadong hospital, Fudan university
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
2
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
J
Jiexian Ma
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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