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NCT Number: NCT05996406

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venetoclax

Drug

Venetoclax 400mg po qd for 1 year

Dexamethasone Oral

Drug

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

Primary outcomes

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

    Time frame: 3 months after treatment initiation

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

  2. Time to next treatment

    Time frame: 2 years

  3. CR+VGPR at 1 month after treatment initiation

    Time frame: 1 month after treatment initiation

  4. CR+VGPR at 6 months after treatment initiation

    Time frame: 6 months after treatment initiation

  5. CR+VGPR at 12 months after treatment initiation

    Time frame: 12 months after treatment initiation

  6. Difference between involved and uninvolved free light chain (dFLC) < 10mg/L

    Time frame: at 1, 3, 6 and 12 months after treatment initiation

  7. Involved free light chain (iFLC) ≤ 20mg/L

    Time frame: at 1, 3, 6 and 12 months after treatment initiation

  8. Minimal residual disease (MRD) negativity

    Time frame: 12 and 24 months after treatment initiation

  9. Time to hematologic response

    Time frame: 1 year

  10. Time to hematologic CR

    Time frame: 1 year

  11. Cardiac response

    Time frame: at 3, 6, 12 and 24 months after treatment initiation

  12. Renal response

    Time frame: at 3, 6, 12 and 24 months after treatment initiation

  13. Hepatic response

    Time frame: at 3, 6, 12 and 24 months after treatment initiation

  14. Time to cardiac response

    Time frame: 2 years

  15. Time to renal response

    Time frame: 2 years

  16. Time to hepatic response

    Time frame: 2 years

  17. Adverse events

    Time frame: treatment initiation to 30 days after last dose of treatment

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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