NCT05546060

Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in HLH

Efficacy and Safety of Venetoclax Combined With Dexamethasone and Etoposide in the Treatment of Hemophagocytic Lymphohistiocytosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to investigate the efficacy and safety of venetoclax combined with dexamethasone and etoposide as a salvage therapy for hemophagocytic lymphohistiocytosis.

Detailed description

Hemophagocytic lymphohistiocytosis (HLH) is a rare and aggressive disease with high mortality and poor prognosis. The HLH-94 and HLH-04 regimens are most commonly used, but approximately 30% of the patients remain unresponsive. Currently, there is no unified evidence-based salvage treatment. There is no unified salvage regimen. This study plans to enroll 20 patients with refractory and recurrent hemophagocytic lymphohistiocytosis. Subjects will receive venetoclax combined with dexamethasone and etoposide for 8 weeks.The safety was evaluated once a week, and the efficacy was evaluated once every 2 weeks. Overall response rate will be evaluated at 8 weeks. Patients were followed up every 3 months thereafter.

Conditions

• Hemophagocytic Lymphohistiocytosis

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax 100mg qd d1，200mg qd d2，400mg qd d3-56
DRUG	Dexamethasone	Dexamethasone 10mg/m2 qd d1-14, 5mg/m2 qd d15-28, 2.5 mg/m2 qd d29-42, and 1.25mg/m2 qd43-56
DRUG	Etoposide	Etoposide 75mg/m2 qw d1-56

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-07-01
• Completion: 2025-10-01
• First posted: 2022-09-19
• Last updated: 2022-09-19

Locations

1 site across 1 country: China