NCT05996406

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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 22, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

August 9, 2023

Last Update Submit

January 19, 2025

Conditions

Light Chain (AL) AmyloidosisCCND1 TranslocationVenetoclax

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation

    3 months after treatment initiation

Secondary Outcomes (17)

  • Overall survival

    2 years

  • Time to next treatment

    2 years

  • CR+VGPR at 1 month after treatment initiation

    1 month after treatment initiation

  • CR+VGPR at 6 months after treatment initiation

    6 months after treatment initiation

  • CR+VGPR at 12 months after treatment initiation

    12 months after treatment initiation

  • +12 more secondary outcomes

Study Arms (1)

Ven-D

EXPERIMENTAL

Venetoclax combined with dexamethasone

Drug: VenetoclaxDrug: Dexamethasone Oral

Interventions

VenetoclaxDRUG

Venetoclax 400mg po qd for 1 year

Ven-D
Dexamethasone OralDRUG

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

Ven-D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proved treatment-naïve AL amyloidosis
  • Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
  • dFLC \> 50mg/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Conditions

Amyloidosis

Interventions

venetoclaxDexamethasone

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 18, 2023

Study Start

September 7, 2023

Primary Completion

November 13, 2024

Study Completion

September 1, 2025

Last Updated

January 22, 2025

Record last verified: 2025-01

Locations

CN(1)