NCT05996406Active, not recruitingPhase 2
Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis with Translocation (11;14)
Venetoclax Combined with Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients with Translocation (11;14): a Multicenter Phase 2 Study
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 7 Sept 2023
- Primary completion date
- 13 Nov 2024
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Amyloidosis
- NCT number
- NCT05996406
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 36
- From 7 Sept 2023 to the primary completion date, 13 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Co-morbidity of uncontrolled infection
- Co-morbidity of other active malignancy
- Hepatitis B virus (HBV)-DNA \> 1000 copies/mL
- Seropositive for hepatitis C (except in the setting of a sustained virologic response)
Lab values
- 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
Other
- 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
Who the study is looking for
- Biopsy proved treatment-naïve AL amyloidosis
- Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%
- dFLC \> 50mg/L
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.