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NCT04754945 · ClinicalTrials.gov registry record · Phase 1
Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis
A Phase 1 study of AL Amyloidosis, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 6
- Study locations
NCT04754945: Active Phase 1 study of AL Amyloidosis, sponsored by Emory University.
NCT04754945 is a Phase 1 study of AL Amyloidosis that is active but no longer recruiting, run by Emory University. The registered enrollment target is 11 participants, below the 424-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04754945, a Phase 1 study of AL Amyloidosis, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis). Isatuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
An event is defined as going off study due to toxicity, death or progression of disease. The events include off-study due to toxicity, death, or progression. The rate will be calculated with an exact 95% confidence interval using the efficacy evaluable population.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Dexamethasone
- DRUG Bortezomib
- BIOLOGICAL Isatuximab
Study Locations (6)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory University Hospital Midtown - Atlanta
California
- University of California - Orange
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Columbia University - New York
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2026-07-24 |
| Phase | Phase 1 |
What the registry record for NCT04754945 still lists
NCT04754945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 424-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04754945 lists 6 locations in 5 states (Georgia, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT04754945 about?
NCT04754945 is a clinical study titled "Isatuximab as Upfront Therapy for the Treatment of High Risk AL Amyloidosis". This phase I trial studies the side effects of isatuximab and to see how well it works in treating patients with high risk immunoglobulin light chain amyloidosis (AL amyloidosis). Isatuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
What is the current status of trial NCT04754945?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-04-28. Estimated completion is 2026-07-24.
What conditions does trial NCT04754945 study?
This clinical trial studies the following conditions: AL Amyloidosis.
What interventions are being tested in trial NCT04754945?
The interventions under investigation include: Cyclophosphamide (DRUG), Dexamethasone (DRUG), Bortezomib (DRUG), Isatuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04754945?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04754945 being conducted?
This trial has 6 study locations across California, Georgia, Michigan, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for AL Amyloidosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04754945's enrollment target sits among peer trials
11 16th of 15 the lowest of 15 other AL Amyloidosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other AL Amyloidosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
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-
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Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource
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RECRUITING · Phase 3
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