Clinical trial · Interventional
L-DEP as an Initial Treatment for EBV-HLH
A Randomized Controlled Trial of L-DEP as an Initial Treatment for Epstein-Barr Virus-associated Hemophagocytic Lymphohistiocytosis
NCT02912702CI-TRIAL-00024019unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as an initial treatment for Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hemophagocytic Lymphohistiocytosis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| doxorubicin hydrochloride liposome injection | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| Pegaspargase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- L-DEP
- description
- Pegaspargase 2000U/m2 day5; doxorubicin hydrochloride liposome injection 25 mg/m2 day 1; etoposide 100 mg/m2 was administered once on the first day of every week; methylprednisolone 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
- interventionNames
- Drug: Pegaspargase
- Drug: doxorubicin hydrochloride liposome injection
- Drug: etoposide
- Drug: methylprednisolone
- type
- ACTIVE_COMPARATOR
- label
- HLH-94 regimen
- description
- Etoposide 150 mg/m2 twice weekly for 2 weeks and then weekly; dexamethasone initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
- interventionNames
- Drug: Etoposide
- Drug: dexamethasone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients were older than 14 years of age 2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH) 3. Patients did not receive any treatment for HLH before 4. Informed consent Exclusion Criteria: 1. Heart function above grade II (NYHA) 2. Accumulated dose of doxorubicin above 300mg/m2 or epirubicin above 450mg/m2 3. Pregnancy or lactating Women 4. Allergic to Pegaspargase, doxorubicin or etoposide 5. Active bleeding of the internal organs 6. uncontrollable infection 7. history of acute and chronic pancreatitis 8. Participate in other clinical research at the same time
References
Publications (1)
- BACKGROUNDWang Y, Huang W, Hu L, Cen X, Li L, Wang J, Shen J, Wei N, Wang Z. Multicenter study of combination DEP regimen as a salvage therapy for adult refractory hemophagocytic lymphohistiocytosis. Blood. 2015 Nov 5;126(19):2186-92. doi: 10.1182/blood-2015-05-644914. Epub 2015 Aug 19. PMID 26289641