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RECRUITING
NCT06629818
PHASE2

Daratumumab Combined With 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 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

Interventions

DRUG

Daratumumab 16 mg/kg (intravenous) or Daratumumab 1800mg (subcutaneous)

qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12

DRUG

Venetoclax

400mg po qd for 1 year

DRUG

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