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NCT02993523 · ClinicalTrials.gov registry record · Phase 3

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy

A Phase 3 study of Acute Myeloid Leukemia (AML), sponsored by AbbVie.

Active
Registry status
Phase 3
Development phase
443
Enrollment target
20
Study locations

NCT02993523 is a Phase 3 study of Acute Myeloid Leukemia (AML) that is active but no longer recruiting, run by AbbVie. The registered enrollment target is 443 participants, above the 130-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (241% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT02993523, a Phase 3 study of Acute Myeloid Leukemia (AML), is active but no longer recruiting, sponsored by AbbVie.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
443 participants
Enrollment target
20
Study locations

Study Summary

Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental drug that kills cancer cells by blocking a protein (part of a cell) that allows cancer cells to stay alive. This study is designed to see if adding venetoclax to azacitidine works better than azacitidine on its own. This is a Phase 3, randomized, double-blind (treatment is unknown to participants and doctors), placebo controlled study in patients with AML who are \>= 18 or more years old and have not been treated before. Participants who take part in this study should not be suitable for standard induction therapy (usual starting treatment). AbbVie is funding this study which will take place at approximately 180 hospitals globally and enroll approximately 400 participants. In this study, 2/3 of participants will receive venetoclax every day with azacitidine and the remaining 1/3 will receive placebo (dummy) tablets with azacitidine. Participants will continue to have study visits and receive treatment for as long as they are having a clinical benefit. The effect of the treatment on AML will be checked by taking blood, bone marrow, scans, measuring side effects and by completing health questionnaires. Blood and bone marrow tests will be completed to see why some people respond better than others. Additional blood tests will be completed for genetic factors and to see how long the drug remains in the body.

Conditions Studied

Acute Myeloid Leukemia (AML)

Interventions

  • DRUG Venetoclax
  • DRUG Placebo
  • DRUG Azacitidine

Study Locations (20)

California

  • City of Hope /ID# 154105 - Duarte
  • University of California, Los Angeles /ID# 154107 - Los Angeles
  • University of California, Davis Comprehensive Cancer Center /ID# 162725 - Sacramento

Massachusetts

  • Massachusetts General Hospital /ID# 200752 - Boston
  • Beth Israel Deaconess Medical Center /ID# 201155 - Boston
  • Dana-Farber Cancer Institute /ID# 167009 - Boston

Illinois

  • Northwestern University Feinberg School of Medicine /ID# 201133 - Chicago
  • University of Chicago Medicine /ID# 154108 - Chicago

New York

  • Columbia Univ Medical Center /ID# 154101 - New York
  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077 - New York

Georgia

  • Emory Midtown Infectious Disease Clinic /ID# 162534 - Atlanta

Indiana

  • Fort Wayne Medical Oncology /ID# 157190 - Fort Wayne

Kansas

  • Cotton-O'Neil Clinical Res Ctr /ID# 155136 - Topeka

Kentucky

  • Norton Cancer Institute /ID# 154992 - Louisville

Trial Details

FieldValue
Enrollment Target 443 participants
Start Date 2017-02-02
Est. Completion 2026-01-23
Phase Phase 3

Sponsor

AbbVie

526 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02993523

The ClinicalTrials.gov registry entry for NCT02993523 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 443 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 130-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target (241% 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 (AML) appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.

NCT02993523 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Massachusetts, Illinois.

Frequently Asked Questions

What is clinical trial NCT02993523 about?

NCT02993523 is a clinical study titled "A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy". Acute Myeloid Leukaemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). Successful treatment of AML is dependent on what subtype of AML the participant has, and the age of the participant when diagnosed. Venetoclax is an experimental...

What is the current status of trial NCT02993523?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 443 participants. The study started on 2017-02-02. Estimated completion is 2026-01-23.

What conditions does trial NCT02993523 study?

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

What interventions are being tested in trial NCT02993523?

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

Who is sponsoring clinical trial NCT02993523?

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

Where is trial NCT02993523 being conducted?

This trial has 20 study locations across California, Georgia, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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