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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Response rate [Срок оценки: Two weeks after initiation of L-DEP regimen combined with PD-1 antibody]

Вторичные конечные точки (4)

• Response rate of lymphoma [Срок оценки: Four weeks after second cycle of L-DEP and PD-1 antibody regimen]
• Progression Free Survival [Срок оценки: 1 years]
• Overall Survival [Срок оценки: 1 years]
• Adverse Events [Срок оценки: 30 days after last administration of cytotoxic drugs]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Friendship Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT05775705 · BFH20220920001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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