Clinical trial · Interventional
L-DEP Regimen Combined With PD-1 Antibody as Induction Therapy for Epstein-Barr Virus-positive LA-HLH
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
NCT05775705CI-TRIAL-00064821completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The efficacy and safety of L-DEP (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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epstein-Barr Virus | — | UNRESOLVED | — |
| Hemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| PD-1 Antibody | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| L-DEP and PD-1 antibody | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- L-DEP and PD-1 antibody
- description
- aspargase, liposomal doxorubicin, etoposide, and methylprednisolone administered in 2 week cycles for 2 cycles
- interventionNames
- Drug: L-DEP and PD-1 antibody
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Two weeks after initiation of L-DEP regimen combined with PD-1 antibody
- description
- complete response (CR) and partial response (PR) rates
Secondary outcomes (3)
- measure
- EBV-DNA clearance at 2 and 4weeks
- timeFrame
- 4 weeks after induction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis. * EBV-DNA in peripheral blood \> 1000 copies/ml or EBER detected in tissue specimens. * Age 18\~70，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.
References
Publications (0)
Data not yet available
No reference posted for this study.