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

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ClinicalTrials.gov Identifier: NCT05996406
Recruitment Status : Recruiting
First Posted : August 18, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Jian Li, Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Light Chain (AL) Amyloidosis CCND1 Translocation Venetoclax Drug: Venetoclax Drug: Dexamethasone Oral Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Venetoclax Combined With Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study
Actual Study Start Date : September 7, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ven-D
Venetoclax combined with dexamethasone
 Drug: Venetoclax
Venetoclax 400mg po qd for 1 year

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


Outcome Measures
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Primary Outcome Measures :
  1. Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation [ Time Frame: 3 months after treatment initiation ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05996406


Contacts
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Contact: Kaini Shen, Dr. +86 13693339884 shenkaini3@sina.com
Contact: Jian Li +86 18610852525 lijian@pumch.cn

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Kaini Shen       shenkaini3@sina.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Jian Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05996406    
Other Study ID Numbers: Ven-D001
First Posted: August 18, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Dexamethasone
Venetoclax
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents