Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT06629818
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100730, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
qw cycle 1-2, q2w cycle 3-6, q4w cycle 7-12
400mg po qd for 1 year
Dexamethasone 20mg po qw for the first 6 months, then 10mg po qw for the next 6 months
Time frame: 3 months after treatment initiation
Time frame: 2 years
Time frame: 2 years
Time frame: 1 month after treatment initiation
Time frame: 6 months after treatment initiation
Time frame: 12 months after treatment initiation
Time frame: at 1, 3, 6 and 12 months after treatment initiation
Time frame: at 1, 3, 6 and 12 months after treatment initiation
Time frame: 12 months after treatment initiation
Time frame: 1 year
Time frame: 1 year
Time frame: at 3, 6 and 12 months after treatment initiation
Time frame: at 3, 6 and 12 months after treatment initiation
Time frame: at 3, 6 and 12 months after treatment initiation
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: treatment initiation to 30 days after last dose of treatment
Peking Union Medical College Hospital
Other
Daratumumab Combined With Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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