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

Launched by BEIJING FRIENDSHIP HOSPITAL · Sep 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of three medications—venetoclax, dexamethasone, and etoposide—to see how well they work and how safe they are for treating hemophagocytic lymphohistiocytosis (HLH), a severe immune system condition. The trial is currently looking for participants aged 18 and older who have been diagnosed with HLH and are expected to live for at least three more months. To qualify, participants should not have certain other health issues, such as severe infections or significant heart disease, and must be able to take oral medications.

If you or a loved one joins this study, you will receive the medication combination and be closely monitored by doctors to track your health and any side effects. Participants will need to agree to use contraception during the study and for six months afterward if they are capable of becoming pregnant. This trial is an important opportunity to explore new treatment options for HLH, and everyone involved will contribute valuable information that could help improve care for others with this condition.

Gender

ALL

Eligibility 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.