Unrelated Cord Blood Transplantation for EBV-associated Lymp...

About this study

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.

Condition: Epstein-Barr Virus-associated Lymphoproliferative Diseases, Chronic Active Epstein-Barr Virus Infection, EBV Associated Lymphoma, Umbilical Cord Blood Transplant
Tested: Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases
Sponsor: Fudan University

Who can join

Age: 14 to 80 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 32

Minimum age: 14 years
Maximum age: 80 years
Study condition: Epstein-Barr Virus-associated Lymphoproliferative Diseases, Chronic Active Epstein-Barr Virus Infection, EBV Associated Lymphoma, Umbilical Cord Blood Transplant
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:
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 17

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.

Where

2 sites, 2 recruiting

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, China

Recruiting

Huashan Hospital, Fudan University