L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA… (NCT05775705) | Clinical Trial Compass
Not Yet RecruitingPhase 3
L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
China25 participantsStarted 2023-08-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Response rate
Timeframe: Two weeks after initiation of L-DEP regimen combined with PD-1 antibody