Status:
ACTIVE_NOT_RECRUITING
Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Light Chain (AL) Amyloidosis
CCND1 Translocation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Biopsy proved treatment-naïve AL amyloidosis
- Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- dFLC \> 50mg/L
Exclusion
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia
- Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)
- Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia
- Seropositive for human immunodeficiency virus
- Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
- Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers, moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study drug
- Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 100×10E9/L.
- Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \> 2.5 × upper limit of normal (ULN), total bilirubin \> 3 × ULN，eGFR \< 15 mL/min, or receiving renal replacement therapy
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05996406
Start Date
September 7 2023
End Date
September 1 2025
Last Update
January 22 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China