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Clinical Trials in China / NCT05996406
Active, not recruiting Phase 2

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

NCT05996406 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 2
Started
2023-09-07
Last updated
2025-01-22

Condition(s) studied

Light Chain (AL) AmyloidosisCCND1 TranslocationVenetoclax

Investigational drug(s) / intervention(s)

VenetoclaxDexamethasone Oral

Venetoclax: Venetoclax 400mg po qd for 1 year

Dexamethasone Oral: Dexamethasone 40mg po qw for the first 6 months, then 10mg po qw for the next 6 months

Study 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 in untreated AL amyloidosis patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05996406 on ClinicalTrials.gov ↗ ← All trials in China