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

Launched by BEIJING FRIENDSHIP HOSPITAL · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a rare condition called Epstein-Barr virus-positive lymphoma-associated hemophagocytic lymphohistiocytosis (LA-HLH). The treatment being tested combines a specific medication regimen called L-DEP, which includes drugs like PEG-aspargase and liposomal doxorubicin, with a PD-1 antibody to see if it can effectively help patients who have this condition. The trial is currently not recruiting participants, but it aims to find out how safe and effective this combination therapy is for patients aged 18 to 65 who have been diagnosed with lymphoma-HLH and have a certain level of the Epstein-Barr virus in their blood.

To be eligible for this trial, participants must have a confirmed diagnosis of lymphoma-HLH and meet specific health criteria, such as having a good heart function and no active internal bleeding. They also need to be able to sign an informed consent form, which means they agree to participate after understanding what the trial involves. If someone joins the study, they can expect to be monitored closely for their response to the treatment and any side effects. It’s important to note that certain health conditions, such as serious heart issues, pregnancy, or certain infections, might exclude someone from participating in this trial.

Gender

ALL

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.