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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06629818
Phase
PHASE2
Status
Recruiting
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Conditions

  • Light Chain (AL) Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Jan 2025
Primary completion
Oct 14, 2026
Completion
Oct 14, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dara-VenD
    Daratumumab combined with venetoclax and dexamethasone

Primary Outcome Measure

Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation [ Time Frame: 3 months after treatment initiation ]

Central Contacts

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