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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
NCT02993523 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 443 participants |
| Start Date | 2017-02-02 |
| Est. Completion | 2026-01-23 |
| Phase | Phase 3 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 443 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02993523 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Massachusetts, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02993523?
The interventions under investigation include: Venetoclax (DRUG), Placebo (DRUG), Azacitidine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02993523?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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