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NCT04847453 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis
A Phase 1 study of Refractory AL Amyloidosis and Recurrent AL Amyloidosis, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 16
- Study locations
NCT04847453: Recruiting Phase 1 study of Refractory AL Amyloidosis and Recurrent AL Amyloidosis, sponsored by National Cancer Institute (NCI).
NCT04847453 is a Phase 1 study of Refractory AL Amyloidosis and Recurrent AL Amyloidosis that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04847453, a Phase 1 study of Refractory AL Amyloidosis and Recurrent AL Amyloidosis, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 16
- Study locations
Study Summary
This phase I/Ia trial finds the best dose and side effects of venetoclax given in combination with ixazomib citrate and dexamethasone in treating patients with light chain amyloidosis that has come back (relapsed) or does not respond to treatment (refractory) and who have an abnormal genetic change \[translocation t(11;14)\]. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ixazomib citrate is in a class of medications called proteasome inhibitors. It works by helping to kill cancer cells. Anti-inflammatory drugs such as dexamethasone reduce inflammation by lowering the body's immune response and are used with other drugs in the treatment of some types of cancer. Combination therapy with venetoclax, ixazomib citrate and dexamethasone may be effective in treatment of relapsed or refractory light chain amyloidosis.
Primary Outcome
Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Echocardiography Test
- DRUG Dexamethasone
- PROCEDURE Bone Marrow Aspiration and Biopsy
Study Locations (16)
New York
- Montefiore Medical Center-Einstein Campus - The Bronx
- Montefiore Medical Center-Weiler Hospital - The Bronx
- Montefiore Medical Center - Moses Campus - The Bronx
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Davis Comprehensive Cancer Center - Sacramento
Massachusetts
- Boston Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Virginia
- University of Virginia Cancer Center - Charlottesville
- VCU Massey Comprehensive Cancer Center - Richmond
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT04847453 shows while recruiting
NCT04847453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Refractory AL Amyloidosis appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04847453 lists 16 locations in 11 states (New York, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04847453 about?
NCT04847453 is a clinical study titled "Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for the Treatment of Relapsed or Refractory Light Chain Amyloidosis". This phase I/Ia trial finds the best dose and side effects of venetoclax given in combination with ixazomib citrate and dexamethasone in treating patients with light chain amyloidosis that has come back (relapsed) or does not respond to treatment (refractory) and who have an abnormal genetic change ...
What is the current status of trial NCT04847453?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-08-03. Estimated completion is 2026-06-30.
What conditions does trial NCT04847453 study?
This clinical trial studies the following conditions: Refractory AL Amyloidosis, Recurrent AL Amyloidosis.
What interventions are being tested in trial NCT04847453?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Echocardiography Test (PROCEDURE), Dexamethasone (DRUG), Bone Marrow Aspiration and Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT04847453?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04847453 being conducted?
This trial has 16 study locations across California, Georgia, Maryland, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04847453's enrollment target sits among peer trials
24 1521st of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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