L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Friendship Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
L-DEP and PD-1 antibody
DrugDoxorubicin (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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: L-DEP and PD-1 antibodyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response rate
complete response (CR) and partial response (PR) rates
Time frame
Two weeks after initiation of L-DEP regimen combined with PD-1 antibodySecondary outcomes
1
Response rate of lymphoma
complete response (CR) and partial response (PR) rates, using the standard response criteria
Time frame
Four weeks after second cycle of L-DEP and PD-1 antibody regimen2
Progression Free Survival
from date of inclusion to date of progression, relapse, or death from any cause
Time frame
1 years3
Overall Survival
from the date of inclusion to date of death, irrespective of cause
Time frame
1 years4
Adverse Events
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
Time frame
30 days after last administration of cytotoxic drugsSponsors and contacts
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Source ClinicalTrials.gov
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