L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH

• Status: Not yet recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The efficacy and safety of L-DEP (PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) regimen combined with PD-1 Antibody an induction therapy for Epstein-Barr virus (EBV)-positive lymphoma-associated hemophagocytic lymphohistiocytosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Antibodies

Criteria

Inclusion Criteria:

• Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis.

• EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens.

• Age 18~65，gender is not limited.

• Estimated survival time ≥ 1 month.

• Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index >250.

• Signed informed consent.

Exclusion Criteria:

• Heart function above grade II (NYHA).

• Severe myocardial injury：TNT、TNI、CK-MB > 3 ULN.

• Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease.

• Pregnancy or lactating Women.

• Allergic to pegylated liposomal doxorubicin，etoposide，or PD-1 antibody.

• Thyroid dysfunction.

• HIV antibody positivity.

• Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable).

• Participate in other clinical research at the same time.

• The researchers considered that patients are not suitable for the study.