Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)
Light Chain (AL) Amyloidosis, CCND1 Translocation, Venetoclax
About this trial
This is an interventional treatment trial for Light Chain (AL) Amyloidosis
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 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
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Ven-D
Venetoclax combined with dexamethasone