Clinical Research Directory
Browse clinical research sites, groups, and studies.
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
Sponsor: Peking Union Medical College Hospital
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 combined with daratumumab and dexamethasone in untreated AL amyloidosis patients.
Official title: Daratumumab Combined With Venetoclax and 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
2024-10-15
Completion Date
2026-10-14
Last Updated
2025-06-03
Healthy Volunteers
No
Conditions
Interventions
Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
Venetoclax
400mg po qd for 1 year
Dexamethasone
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China