NCT05996406

Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)

Venetoclax Combined with Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients with Translocation (11;14): a Multicenter Phase 2 Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy could induce rapid and profound hematologic response in AL patients with favorable safety profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the efficacy and safety of venetoclax in untreated AL amyloidosis patients.

Conditions

• Light Chain (AL) Amyloidosis
• CCND1 Translocation
• Venetoclax

Interventions

Type	Name	Description
DRUG	Venetoclax	Venetoclax 400mg po qd for 1 year
DRUG	Dexamethasone Oral	Dexamethasone 40mg po qw for the first 6 months, then 10mg po qw for the next 6 months

Timeline

• Start date: 2023-09-07
• Primary completion: 2024-11-13
• Completion: 2025-09-01
• First posted: 2023-08-18
• Last updated: 2025-01-22

Locations

1 site across 1 country: China