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

Recruiting Phase 2 Interventional Study
Light Chain (AL) Amyloidosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Peking Union Medical College Hospital · Other
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About This Trial
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 comb…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Biopsy proved treatment-naïve AL amyloidosis * Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10% * dFLC \> 50mg/L Exclusion Criteria: * Co-morbidity of uncontrolled infection * Co-morbidity of other active malignancy * Co-diagnosis of multiple myeloma or waldenstrom m…
Contacts

Kaini Shen

86-13693339884

shenkaini3@sina.com

CONTACT

Jian Li

86-18610852525

lijan@pumch.cn

CONTACT