L-DEP/DEP Regimen and PD-1 Antibody as a Treatment for Relapse/Refractory EBV-HLH

Launched by BEIJING FRIENDSHIP HOSPITAL · Mar 30, 2022

Keywords

ClinConnect Summary

This clinical trial is designed to test a new treatment combination for patients with a serious condition called Epstein-Barr virus-associated hemophagocytic lymphohistiocytosis (EBV-HLH), which can be life-threatening. The study will look at how well a treatment called L-DEP (a mix of medications) works when combined with a PD-1 antibody. This trial is aimed at patients who have already received previous treatment but did not improve.

To participate, patients must be diagnosed with EBV-HLH and have specific test results showing the virus's presence. They should also be unable to receive a stem cell transplant soon for various reasons. Eligible participants can be any age over 1 year old and of any gender. Before joining, they will need to provide informed consent and meet certain health criteria, such as normal heart function and no serious infections. While this study is not yet recruiting participants, it offers hope for those who haven't had success with standard treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were diagnosed with EBV associated HLH (EBV-HLH).
• • 2. EBV-DNA in peripheral blood or EBER in tissue were positive.
• • 3. Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least partial response
• • 4. The patient is expected to be unable to undergo allogeneic hematopoietic stem cell transplantation in the short term due to various reasons (physical status, economic reasons, donor reasons, etc.)
• • 5. The expected survival time is more than 1 month.
• • 6. Age ≤ years old, gender is not limited.
• • 7. Serum creatinine ≤ 1.5 times normal；After infusion, fibrinogen can be corrected to ≥0.6g/L.
• • 8. Serum human immunodeficiency virus(HIV) antigen or antibody negative； Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；HBV copies less than 1E+03 copies/ml.
• • 9. The left ventricular ejection fraction (LVEF) was normal.
• • 10. No uncontrollable infection.
• • 11. Contraception for both male or female.
• • 12. Informed consent obtained.
• Exclusion Criteria:
• • 1. Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection
• • 2. Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN (upper limit of normal)
• • 3. Heart function above grade II (NYHA).
• • 4. Thyroid dysfunction
• • 5. Serious mental illness;
• • 6. Active hemorrhage of internal organs
• • 7. Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was ineffective or relapsed
• • 8. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
• • 9. Participate in other clinical research at the same time.