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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Dexamethasone; Etoposide; Venetoclax

Criteria

Inclusion Criteria:

• age ≥18 years old, expected survival time more than 3 months;

• met HLH-2004 diagnostic criteria；

• ECOG score 0-2；

• ECG QTcF interval: male ≤450ms, female ≤470ms;

• AST and ALT ≤3.0 ULN, TB ≤1.5×ULN；serum creatinine≤1.5×ULN，or CrCL ≥ 50mL/min；INR、APTT、PT ≤1.5×ULN；

• without pregnancy or lactation, and agree to contraception during and for at least 6 months after the study；

• signed informed consent.

Exclusion Criteria:

• patients with malignancies unrelated to HLH, except for fully recovered non-melanoma skin cancer and carcinoma in situ;

• patients participated in other clinical trials within 4 weeks；

• previously treated with Bcl-2 inhibitors；

• unable to take oral medication；

• history of substance abuse or patients with mental illness；

• severe infection；

• cardiovascular disease，NYHA II-IV；

• allergic to venetoclax or etoposide.