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

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

NCT ID: NCT05775705

Condition: PD-1 Antibody
Hemophagocytic Lymphohistiocytosis
Epstein-Barr Virus
Lymphoma

Conditions: Official terms:
Epstein-Barr Virus Infections
Lymphoma
Lymphohistiocytosis, Hemophagocytic
Antibodies

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: L-DEP and PD-1 antibody
Description: Doxorubicin (doxorubicin hydrochloride liposome injection) 35 mg/m2 day 1; etoposide 75 mg/m2 day1; methylprednisolone 1.5mg/kg days 1 to 3, 0.25mg/kg day 4 to 14; PEG-aspargase 6000iu/m2 day2, day4; PD-1 antibody injection 200mg day 5.
Arm group label: L-DEP and PD-1 antibody

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.

Detailed description: Lymphoma-associated hemophagocytic lympohistiocytosis is a refractory immune disorder with high mortality. Without early intervention, the median survival time is less than 2 months. Currently, HLH-94 or HLH-04 are the standard HLH treatment regimens, which have improved the disease response rate to approximately 70% and increased the 5-year OS rate to 50%. However, approximately, 30% of the patients remain unresponsive to standard therapy, especially if HLH is lymphoma-associated. Therefore, we conduct a prospective clinical study to explore 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis. - EBV-DNA in peripheral blood > 1000 copies/ml or EBER detected in tissue specimens. - Age 18~65，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.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Beijing Friendship Hospital, Capital Medical University

Address:
City: Beijing
Zip: 100050
Country: China

Start date: August 1, 2023

Completion date: October 1, 2026

Lead sponsor:
Agency: Beijing Friendship Hospital
Agency class: Other

Source: Beijing Friendship Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05775705