---
title: L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis
nct_id: NCT02631109
overall_status: UNKNOWN
phase: PHASE3
sponsor: Beijing Friendship Hospital
study_type: INTERVENTIONAL
primary_condition: Hemophagocytic Lymphohistiocytosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02631109.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02631109"
ct_last_update_post_date: 2016-08-04
last_seen_at: "2026-05-12T06:36:33.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# L-DEP Regimen as a Salvage Therapy for Refractory Epstein Barr Virus-induced Hemophagocytic Lymphohistiocytosis

**NCT ID:** [NCT02631109](https://clinicaltrials.gov/study/NCT02631109)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Beijing Friendship Hospital
- **Conditions:** Hemophagocytic Lymphohistiocytosis
- **Start Date:** 2015-12
- **Completion Date:** 2019-11
- **CT.gov Last Update:** 2016-08-04

## Brief Summary

This study aimed to investigate the efficacy and safety of Pegaspargase together with liposomal doxorubicin, etoposide and high dose methylprednisolone (L-DEP) as a salvage therapy for refractory Epstein Barr virus-induced hemophagocytic lymphohistiocytosis.

## Eligibility

- **Minimum age:** 14 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Patients were older than 14 years of age
2. Diagnosed as EBV-Hemophagocytic Lymphohistiocytosis (HLH)
3. Patients did not achieve at lease partial response after initial treatment including HLH-94 or DEP no less than 2 weeks
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
```

## Arms

- **L-DEP** (EXPERIMENTAL) — Pegaspargase 2000U/m2 day5; doxorubicin (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

## Interventions

- **Pegaspargase** (DRUG) — 2000U/m2 day5
- **doxorubicin** (DRUG) — 25mg/m2 day1
- **etoposide** (DRUG) — 100 mg/m2 was administered once on the first day of every week
- **methylprednisolone** (DRUG) — 15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7

## Primary Outcomes

- **Evaluation of treatment response** _(time frame: Change from before and 2,4,6 and 8 weeks after initiating L-DEP salvage therapy)_ — A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).

A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was\>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; for patients with an initial neutrophil count of\<0.5 ×109/L, a response was defined as an increase by at least 100% to\>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to \>2.0 × 109/L was considered a response; and for patients with ALT \>400 U/L, response was defined as an ALT decrease of at least 50%.
- **Change of Epstein-Barr virus(EBV)-DNA** _(time frame: Change from before and 2, 4, 6 and 8 weeks after initiating L-DEP salvage therapy)_

## Secondary Outcomes

- **Survival** _(time frame: from the time patients received L-DEP salvage therapy up to 24 months or November 2019)_
- **Adverse events that are related to treatment** _(time frame: through study completion, an average of 2 years)_

## Locations (1)

- Beijing Friendship Hospital, Capital Medical University, Beijing, Beijing Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing friendship hospital, capital medical university|beijing|beijing municipality|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02631109.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02631109*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*