Unrelated Cord Blood Transplantation for EBV-associated Lymphoproliferative Disorders

NCT07381738 | Recruiting Phase 2 DMC

• 1 other identifier: 2025K399
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Umbilical Cord Blood Transplant; Epstein-Barr Virus-associated Lymphoproliferative Diseases; Chronic Active Epstein-Barr Virus Infection; EBV Associated Lymphoma

Keywords

Epstein-Barr virus-associated lymphoproliferative diseases; Chronic Active Epstein-Barr Virus Infection; EBV Associated Lymphoma; Umbilical Cord Blood Transplant

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The percentage of patients who achieved complete response (CR) or partial response (PR) after umbilical cord blood transplantation, out of the total number of patients evaluable for efficacy.

  3 months

Secondary Outcomes (2)

• Survival

  1 year

• Treatment-Related Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

Treatment arm

EXPERIMENTAL

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.

Procedure: Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases

Interventions

Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases PROCEDURE

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.

Treatment arm

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead
• Huashan Hospital: collaborator

Study Sites (2)

Huadong hospital, Fudan university

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Study Officials

• Jiexian Ma

  Huadong Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiexian Ma

CONTACT

+86 13764520566; jiexianma@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: 1 year after completion of this study

Locations

CN (2)