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

NCT ID: NCT05775705

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2026-10-01

Brief 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.

Conditions

PD-1 Antibody; Hemophagocytic Lymphohistiocytosis; Epstein-Barr Virus; Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

L-DEP and PD-1 antibody

PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles

Group Type: EXPERIMENTAL

L-DEP and PD-1 antibody

Intervention Type: DRUG

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.

Interventions

L-DEP and PD-1 antibody

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Wang

Professor and Head of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhao Wang, MD

Role: CONTACT

wangzhao@ccmu.edu.cn

63138303

Other Identifiers

BFH20220920001

Identifier Type: -

Identifier Source: org_study_id