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.
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