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NCT04086264 · ClinicalTrials.gov registry record · Phase 1

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

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

Active
Registry status
Phase 1
Development phase
218
Enrollment target
20
Study locations

NCT04086264 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 218 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% higher). The trial reports 20 study locations across 18 states.

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The verdict

NCT04086264, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
218 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

Conditions Studied

Acute Myeloid Leukemia

Interventions

  • DRUG Venetoclax
  • DRUG Azacitidine
  • DRUG IMGN632

Study Locations (20)

California

  • City of Hope National Medical Center /ID# 269273 - Duarte
  • University Of California Irvine Medical Center /ID# 269275 - Orange

New York

  • Roswell Park Cancer Institute /ID# 269266 - Buffalo
  • New York Presbyterian Hospital Weill Cornell Medical Center /ID# 269271 - New York

Florida

  • Moffitt Cancer Center /ID# 269269 - Tampa

Illinois

  • Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 269642 - Chicago

Massachusetts

  • Dana-Farber Cancer Institute /ID# 269267 - Boston

Michigan

  • University of Michigan /ID# 269079 - Ann Arbor

Minnesota

  • Mayo Clinic Hospital Rochester /ID# 269643 - Rochester

North Carolina

  • Duke University Health System /ID# 269268 - Durham

Trial Details

FieldValue
Enrollment Target 218 participants
Start Date 2019-11-06
Est. Completion 2027-02
Phase Phase 1

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04086264

The ClinicalTrials.gov registry entry for NCT04086264 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (90% higher). The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT04086264 reports 20 study locations spanning 18 distinct geographic areas - top geographies include California, New York, Florida.

Frequently Asked Questions

What is clinical trial NCT04086264 about?

NCT04086264 is a clinical study titled "IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia". This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

What is the current status of trial NCT04086264?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 218 participants. The study started on 2019-11-06. Estimated completion is 2027-02.

What conditions does trial NCT04086264 study?

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

What interventions are being tested in trial NCT04086264?

The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), IMGN632 (DRUG).

Who is sponsoring clinical trial NCT04086264?

This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04086264 being conducted?

This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. 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.