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NCT05451771 · ClinicalTrials.gov registry record · Phase 1

Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis

A Phase 1 study of AL Amyloidosis, sponsored by Rajshekhar Chakraborty, MD.

Recruiting
Registry status
Phase 1
Development phase
53
Enrollment target
4
Study locations

NCT05451771 is a Phase 1 study of AL Amyloidosis that is actively recruiting participants, run by Rajshekhar Chakraborty, MD. The registered enrollment target is 53 participants, below the 421-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (87% lower). The trial reports 4 study locations across 4 states.

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The verdict

NCT05451771, a Phase 1 study of AL Amyloidosis, is actively recruiting participants, sponsored by Rajshekhar Chakraborty, MD.

RECRUITING
Registry status
Phase 1
Development phase
53 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.

Conditions Studied

Interventions

  • DRUG Venetoclax Oral Tablet, 200 mg
  • DEVICE FISH assay
  • DRUG Venetoclax Oral Tablet, 400 mg
  • DRUG Dexamethasone Oral, 10 mg
  • DRUG Dexamethasone Oral, 20 mg

Study Locations (4)

Massachusetts

  • Boston Medical Center - Boston

Minnesota

  • Mayo Clinic Rochester - Rochester

New York

  • New York Presbyterian Hospital/Columbia University Irving Medical Center - New York

Wisconsin

  • Froedtert Hospital & the Medical College of Wisconsin - Milwaukee

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2022-10-26
Est. Completion 2026-09
Phase Phase 1

Sponsor

Rajshekhar Chakraborty, MD

2 total trials

What the Registry Record Tells You About NCT05451771

The ClinicalTrials.gov registry entry for NCT05451771 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 421-participant average among 15 other AL Amyloidosis trials with a reported enrollment target (87% lower). The listed sponsor is Rajshekhar Chakraborty, MD, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with AL Amyloidosis appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax Oral Tablet, 200 mg is the first listed.

NCT05451771 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Minnesota, New York.

Frequently Asked Questions

What is clinical trial NCT05451771 about?

NCT05451771 is a clinical study titled "Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis". The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.

What is the current status of trial NCT05451771?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2022-10-26. Estimated completion is 2026-09.

What conditions does trial NCT05451771 study?

This clinical trial studies the following conditions: AL Amyloidosis.

What interventions are being tested in trial NCT05451771?

The interventions under investigation include: Venetoclax Oral Tablet, 200 mg (DRUG), FISH assay (DEVICE), Venetoclax Oral Tablet, 400 mg (DRUG), Dexamethasone Oral, 10 mg (DRUG), Dexamethasone Oral, 20 mg (DRUG).

Who is sponsoring clinical trial NCT05451771?

This trial is sponsored by Rajshekhar Chakraborty, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05451771 being conducted?

This trial has 4 study locations across Massachusetts, Minnesota, New York, Wisconsin. 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

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