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Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis

ConditionHemophagocytic Lymphohistiocytoses
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-70
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This study is trying to evaluate the efficacy and safety of modified DEP regimens for the treatment of active hemophagocytic lymphohistiocytosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

According to the HLH-2004 criteria, the patient meets the HLH diagnosis.

1 year old < age < 70 years old, regardless of gender.

Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times the normal value; fibrinogen can be corrected to ≥ 0.6g/L after infusion.

Disqualifiers

Allergic to liposome doxorubicin, etoposide, and ruxolitinib or with severe allergic constitution;

Severe myocardial damage, with myocardial enzyme CK and CK-MB increased more than 3 times ULN (upper limit of normal value).

Patients with heart disease of grade II or above (including grade II) according to the New York Heart Association (NYHA) score.

Subjects who have used a total cumulative dose of doxorubicin ≥300mg/m2 or a total cumulative dose of epirubicin ≥450mg/m2, or who have previously used anthracyclines to cause heart disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • modified-DEP

    Drug

    For non-EBV-HLH patients: Liposomes doxorubicin, 25 mg/m2 d1, etoposide 100 mg/m2 d1, methylprednisolone 1 mg/kg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed. For EBV-HLH patients: PD-1 monoclonal antibody, 2 mg/kg (maximum dose, 200 mg) d-3, liposomes doxorubicin, 25 mg/m2 d1, etoposide 100 mg/m2 d1, methylprednisolone 1 mg/kg d1-3, then tapering according to patients condition, fully stop with d7 to d10; ruxolitinib, 15 mg bid. Emapalumab, if needed.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: modified-DEP for HLHExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate of modified-DEP

Rates of complete response, partial response, improvement

Time frame
2 weeks, 4 weeks, 6 weeks, 8 weeks
2

Incidence of Treatment-Emergent Adverse Events

Rates of adverse events

Time frame
2 weeks, 4 weeks, 6 weeks, 8 weeks

Secondary outcomes

1

Survival of patients

The disease outcomes, 3-month and 6-month survival rates, and median survival

Time frame
3 months, 6 months, 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: