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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05996406
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

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

Interventions

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

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 in untreated AL amyloidosis patients.

Key Dates

Start date
Sep 7, 2023
Status verified
Jan 2025
Primary completion
Nov 13, 2024
Completion
Sep 30, 2025

Study Design

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

Arms

  • Experimental: Ven-D
    Venetoclax combined with 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 ]

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