Status:
NOT_YET_RECRUITING
L-DEP/DEP Regimen and PD-1 Antibody as a Treatment for Relapse/Refractory EBV-HLH
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Hemophagocytic Lymphohistiocytosis
Eligibility:
All Genders
1-70 years
Phase:
PHASE3
Brief Summary
This study aimed to investigate the efficacy and safety of L-DEP (L-Asparaginasum, liposomal doxorubicin, etoposide and methylprednisolone) together with PD-1 antibody as an treatment for relapse/refr...
Detailed Description
PD-1 antibody added to the DEP regimen （with or without asparaginases） in EBV-HLH
Eligibility Criteria
Inclusion
- Meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;patients were diagnosed with EBV associated HLH (EBV-HLH).
- EBV-DNA in peripheral blood or EBER in tissue were positive.
- Treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least partial response
- 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.)
- The expected survival time is more than 1 month.
- Age ≤ years old, gender is not limited.
- Serum creatinine ≤ 1.5 times normal；After infusion, fibrinogen can be corrected to ≥0.6g/L.
- 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.
- The left ventricular ejection fraction (LVEF) was normal.
- No uncontrollable infection.
- Contraception for both male or female.
- Informed consent obtained.
Exclusion
- Allergic to doxorubicin and/or etoposide and/or PD-1 antibody Injection
- Severe myocardial injury, myocardial enzymes CK, CK-MB increased more than 3 times ULN (upper limit of normal)
- Heart function above grade II (NYHA).
- Thyroid dysfunction
- Serious mental illness;
- Active hemorrhage of internal organs
- Previously received L-DEP regimen for HLH-targeted treatment, but the treatment was ineffective or relapsed
- Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2
- Participate in other clinical research at the same time.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05315336
Start Date
June 1 2022
End Date
June 1 2026
Last Update
April 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Friendship Hospital, Capital Medical University
Beijing, China