Trials / Recruiting

RecruitingNCT07381738

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

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 80 (estimated)

Sponsor: Fudan University · Academic / Other
Sex: All
Age: 14 Years – 80 Years
Healthy volunteers: Not accepted

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.

Detailed description

Epstein-Barr virus-associated lymphoproliferative diseases (EBV-LPDs) are a group of disorders characterized by abnormal proliferation of lymphocytes caused by or associated with Epstein-Barr virus (EBV) infection. Among these, chronic active EBV infection (CAEBV) is a severe systemic EBV-positive lymphoproliferative disease predominantly seen in East Asian populations, especially in Japan, China, and Korea. Unlike in Western countries where B cells are primarily affected, EBV in Asian CAEBV patients mainly infects T cells or NK cells. The clinical manifestations of CAEBV are diverse, including fever, hepatosplenomegaly, lymphadenopathy, rash, and hypersensitivity to mosquito bites. Serious complications include hemophagocytic lymphohistiocytosis (HLH), liver failure, interstitial pneumonia, and coronary artery lesions. Current treatment strategies for CAEBV include immunomodulatory therapy, chemotherapy (including etoposide-containing regimens such as L-DEP, CHOP, etc.), and allogeneic hematopoietic stem cell transplantation. Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is currently the only potentially curative approach. Patients with severe CAEBV have an extremely poor prognosis without undergoing hematopoietic stem cell transplantation. EBV-associated lymphomas refer to a category of malignant lymphoid neoplasms driven or implicated in pathogenesis by EBV infection. By infecting B cells, T cells, or NK cells, EBV leads to abnormal cell proliferation and malignant transformation, ultimately resulting in lymphoma. EBV-associated lymphomas are highly heterogeneous, necessitating precise stratification of treatment regimens. For high-risk and refractory EBV-associated lymphomas, allogeneic hematopoietic stem cell transplantation is an effective treatment method. Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a therapeutic procedure that involves the infusion of hematopoietic stem cells from a healthy donor to reconstitute the patient's hematopoietic and immune systems. Numerous international studies have demonstrated that Allo-HSCT is an effective treatment for various EBV-LPDs. Umbilical cord blood transplantation (UCBT) is a specific type of Allo-HSCT. Umbilical cord blood refers to the blood remaining in the umbilical cord and placenta after the cord of a newborn is clamped. This blood is rich in hematopoietic stem cells, and transplantation using this cord blood is termed umbilical cord blood hematopoietic stem cell transplantation. Given that both the Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Active EBV Disease and international CAEBV management consensuses indicate that Allo-HSCT is currently the only potentially curative method for CAEBV, and considering that internationally published small-sample studies have shown favorable efficacy of UCBT in EBV-LPDs such as CAEBV, data across different disease subtypes remain limited. Therefore, this study aims to further validate the efficacy and safety of unrelated umbilical cord blood transplantation for EBV-associated lymphoproliferative diseases through a single-center, prospective investigation.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Umbilical cord blood transplantation as treatment of Epstein-Barr virus-associated lymphoproliferative diseases	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.

Timeline

Start date: 2026-01-01
Primary completion: 2028-12-31
Completion: 2028-12-31
First posted: 2026-02-02
Last updated: 2026-02-02

Locations

2 sites across 1 country: China

Source: ClinicalTrials.gov record NCT07381738. Inclusion in this directory is not an endorsement.