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Completed NCT05775705

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

Conditions: PD-1 Antibody, Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus, Lymphoma

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Beijing Friendship Hospital

Location: Beijing Friendship Hospital, Capital Medical University Beijing Beijing Municipality

Summary

The efficacy and safety of L-DEP (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.

Eligibility Criteria

Inclusion Criteria: * Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis. * EBV-DNA in peripheral blood \> 1000 copies/ml or EBER detected in tissue specimens. * Age 18\~70,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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05775705). StuddyBuddy aggregates publicly available trial information.