Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy proved treatment-naïve AL amyloidosis

• Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%

• dFLC \> 50mg/L

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Kaini Shen
shenkaini3@sina.com
86-13693339884
Backup
Jian Li
lijan@pumch.cn
86-18610852525
Time Frame
Start Date: 2024-10-15
Estimated Completion Date: 2026-10-14
Participants
Target number of participants: 36
Treatments
Experimental: Dara-VenD
Daratumumab combined with venetoclax and dexamethasone
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov