Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05996406
Other study ID # Ven-D001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 7, 2023
Est. completion date September 2025

Study information

Verified date June 2024
Source Peking Union Medical College Hospital
Contact n/a
Is FDA regulated No
Health authority
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 Active, not 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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Withdrawn NCT05692908 - An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis Phase 1
Withdrawn NCT04943302 - Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis Phase 2
Not yet recruiting NCT06097832 - Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis Phase 1
Recruiting NCT05486481 - Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) Phase 1/Phase 2
Recruiting NCT06376214 - Daratumumab for Patients With Light Chain Amyloidosis N/A
Recruiting NCT04973137 - A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis Phase 3
Completed NCT02015312 - A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) Phase 2
Recruiting NCT04316442 - Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis Phase 1/Phase 2