L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
- Conditions
- PD-1 AntibodyHemophagocytic LymphohistiocytosisLymphomaEpstein-Barr Virus
- Interventions
- Drug: L-DEP and PD-1 antibody
- Registration Number
- NCT05775705
- Lead Sponsor
- Beijing Friendship Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description L-DEP and PD-1 antibody L-DEP and PD-1 antibody PEG-aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
- Primary Outcome Measures
Name Time Method Response rate Two weeks after initiation of L-DEP regimen combined with PD-1 antibody complete response (CR) and partial response (PR) rates
- Secondary Outcome Measures
Name Time Method Overall Survival 1 years from the date of inclusion to date of death, irrespective of cause
Progression Free Survival 1 years from date of inclusion to date of progression, relapse, or death from any cause
Response rate of lymphoma Four weeks after second cycle of L-DEP and PD-1 antibody regimen complete response (CR) and partial response (PR) rates, using the standard response criteria
Adverse Events 30 days after last administration of cytotoxic drugs any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
Trial Locations
- Locations (1)
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China