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

Light Chain (AL) Amyloidosis Clinical Trial

Official title:

Venetoclax Combined With Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996406
• Other study ID #: Ven-D001
• Status: Recruiting
• Phase: Phase 2
• Start date: September 7, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: Peking Union Medical College Hospital
• Contact: Kaini Shen, Dr.
• Phone: +86 13693339884
• Email: shenkaini3[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Light Chain (AL) Amyloidosis
• Venetoclax

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation		3 months after treatment initiation
Secondary	Overall survival		2 years
Secondary	Time to next treatment		2 years
Secondary	CR+VGPR at 1 month after treatment initiation		1 month after treatment initiation
Secondary	CR+VGPR at 6 months after treatment initiation		6 months after treatment initiation
Secondary	CR+VGPR at 12 months after treatment initiation		12 months after treatment initiation
Secondary	Difference between involved and uninvolved free light chain (dFLC) < 10mg/L		at 1, 3, 6 and 12 months after treatment initiation
Secondary	Involved free light chain (iFLC) = 20mg/L		at 1, 3, 6 and 12 months after treatment initiation
Secondary	Minimal residual disease (MRD) negativity		12 and 24 months after treatment initiation
Secondary	Time to hematologic response		1 year
Secondary	Time to hematologic CR		1 year
Secondary	Cardiac response		at 3, 6, 12 and 24 months after treatment initiation
Secondary	Renal response		at 3, 6, 12 and 24 months after treatment initiation
Secondary	Hepatic response		at 3, 6, 12 and 24 months after treatment initiation
Secondary	Time to cardiac response		2 years
Secondary	Time to renal response		2 years
Secondary	Time to hepatic response		2 years
Secondary	Adverse events		treatment initiation to 30 days after last dose of treatment