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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 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.

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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.

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

FieldValue
Enrollment Target 11 participants
Start Date 2021-04-28
Est. Completion 2026-07-24
Phase Phase 1

Sponsor

Emory University

1,208 total trials

What the Registry Record Tells You About NCT04754945

The ClinicalTrials.gov registry entry for NCT04754945 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 424-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (97% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.