Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease

Launched by BEIJING CHILDREN'S HOSPITAL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve stem cell transplants for patients with a rare blood condition called Epstein Barr Virus T/NK lymphoproliferative disease (EBV-T/NK LPD). The researchers want to see if adding a special medicine, called an anti-CD25 antibody, to the usual treatment can help prevent a common complication after transplant called graft-versus-host disease (GVHD). GVHD happens when the donated cells attack the patient's body, causing serious problems. The study will also look at whether this new approach can reduce other transplant-related issues, like the body not accepting the transplant well or the virus coming back early.

Children 18 years old or younger who have been diagnosed with EBV-T/NK LPD and are planning to have a stem cell transplant at the study hospital may be eligible. There are some specific conditions related to the donor or the patient's disease activity that need to be met, and participants must agree to join the study by signing a consent form. If selected, patients will receive the usual transplant treatment plus the additional anti-CD25 antibody medicine. The trial is currently recruiting participants and aims to make transplants safer and more effective for patients with this serious disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
• • Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
• • Age ≤ 18 years old
• • Sign informed consent form
• • Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 \^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)\<10mg/kg
• Exclusion Criteria:
• • The expected survival period for multiple organ failure is no more than 3 months
• • Not signing the informed consent form