L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: L-DEP and PD-1 antibody.
- Who it may be relevant to
- Registry conditions: PD-1 Antibody, Hemophagocytic Lymphohistiocytosis, Epstein-Barr Virus, Lymphoma. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of L-DEP Regimen Combined With PD-1 Antibody an Induction Therapy for Epstein-Barr Virus (EBV)-Positive Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Response rate [Time frame: Two weeks after initiation of L-DEP regimen combined with PD-1 antibody]
Secondary outcome measures (4)
- Response rate of lymphoma [Time frame: Four weeks after second cycle of L-DEP and PD-1 antibody regimen]
- Progression Free Survival [Time frame: 1 years]
- Overall Survival [Time frame: 1 years]
- Adverse Events [Time frame: 30 days after last administration of cytotoxic drugs]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Friendship Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT05775705 · BFH20220920001