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ACTIVE NOT RECRUITING
NCT05996406
PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-09-07

Completion Date

2025-09

Last Updated

2025-01-22

Healthy Volunteers

No

Interventions

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

Locations (1)

Peking Union Medical College Hospital

Beijing, China