NCT06504030

Modified DEP Regimens for the Treatment of Hemophagocytic Lymphohistiocytosis

A Single-arm, Single-center, Prospective Study of Modified DEP Regimens (Doxorubicin+ Etoposide + Methylprednisolone) for the Treatment of Hemophagocytic Lymphohistiocytosis

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

In the investigators' previous clinical practice, it has been found that under the condition of combined treatment with safer inflammatory factors such as ruxolitinib and CCRT, further reducing the dosage of high-dose hormones and shortening the duration of use can effectively reduce the occurrence of adverse reactions while still achieving the effect of effectively alleviating HLH. This study is a prospective clinical study aimed at observing the effectiveness and safety of the modified DEP regimen in the treatment of active HLH.

Conditions

• Hemophagocytic Lymphohistiocytoses

Interventions

Type	Name	Description
DRUG	modified-DEP	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2027-02-01
• First posted: 2024-07-16
• Last updated: 2024-08-05