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

Capital Medical University

Status and phase

Not yet enrolling

Phase 3

Conditions

PD-1 Antibody

Epstein-Barr Virus

Hemophagocytic Lymphohistiocytosis

Lymphoma

Treatments

Drug: L-DEP and PD-1 antibody

Study type

Interventional

Funder types

Other

Identifiers

NCT05775705

BFH20220920001

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.