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NCT04887857 · ClinicalTrials.gov registry record · Phase 1

A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)

A Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Celgene.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target
10
Study locations

NCT04887857 is a Phase 1 study of Leukemia, Myeloid, Acute that has completed, run by Celgene. The registered enrollment target is 6 participants, below the 116-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (95% lower). The trial reports 10 study locations across 9 states.

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The verdict

NCT04887857, a Phase 1 study of Leukemia, Myeloid, Acute, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target
10
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

Conditions Studied

Leukemia, Myeloid, Acute

Interventions

  • DRUG Venetoclax
  • DRUG CC-486

Study Locations (10)

New York

  • Local Institution - 106 - New York
  • Local Institution - 113 - New York

California

  • Local Institution - 104 - Stanford

Colorado

  • Local Institution - 110 - Denver

Massachusetts

  • Local Institution - 105 - Boston

Ohio

  • Local Institution - 102 - Cleveland

Oklahoma

  • Local Institution - 111 - Oklahoma City

Texas

  • Local Institution - 101 - Houston

Victoria

  • Local Institution - 202 - North Melbourne

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2021-12-01
Est. Completion 2024-01-08
Phase Phase 1

Sponsor

Celgene

308 total trials

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What the Registry Record Tells You About NCT04887857

The ClinicalTrials.gov registry entry for NCT04887857 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (95% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 2 interventions - of which Venetoclax is the first listed.

NCT04887857 reports 10 study locations spanning 9 distinct geographic areas - top geographies include New York, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04887857 about?

NCT04887857 is a clinical study titled "A Study to Assess Safety and Tolerability of CC-486 (ONUREG®, Oral Azacitidine) in Combination Therapy in Participants With Acute Myeloid Leukemia (AML)". The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of CC-486 (ONUREG®) in combination with venetoclax in relapsed and/or refractory Acute Myeloid Leukemia (AML) and newly diagnosed AML.

What is the current status of trial NCT04887857?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-12-01. Estimated completion is 2024-01-08.

What conditions does trial NCT04887857 study?

This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.

What interventions are being tested in trial NCT04887857?

The interventions under investigation include: Venetoclax (DRUG), CC-486 (DRUG).

Who is sponsoring clinical trial NCT04887857?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04887857 being conducted?

This trial has 10 study locations across California, Colorado, Massachusetts, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.