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
Public ClinicalTrials.gov record NCT02993523. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo Controlled Phase 3 Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Subjects With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02993523
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 443 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 1, 2017
- Primary completion
- Nov 30, 2021
- Completion
- Jun 14, 2026
- Last update posted
- Jun 10, 2026
2017 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope /ID# 154105 | Duarte | California | 91010 | — |
| University of California, Los Angeles /ID# 154107 | Los Angeles | California | 90095 | — |
| University of California, Davis Comprehensive Cancer Center /ID# 162725 | Sacramento | California | 95817 | — |
| Emory Midtown Infectious Disease Clinic /ID# 162534 | Atlanta | Georgia | 30322 | — |
| Northwestern University Feinberg School of Medicine /ID# 201133 | Chicago | Illinois | 60611-2927 | — |
| University of Chicago Medicine /ID# 154108 | Chicago | Illinois | 60637-1426 | — |
| Fort Wayne Medical Oncology /ID# 157190 | Fort Wayne | Indiana | 46804 | — |
| Cotton-O'Neil Clinical Res Ctr /ID# 155136 | Topeka | Kansas | 66606 | — |
| Norton Cancer Institute /ID# 154992 | Louisville | Kentucky | 40202-3700 | — |
| EMMC Cancer Care /ID# 154991 | Brewer | Maine | 04412 | — |
| Johns Hopkins University /ID# 154104 | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital /ID# 200752 | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center /ID# 201155 | Boston | Massachusetts | 02215-5400 | — |
| Dana-Farber Cancer Institute /ID# 167009 | Boston | Massachusetts | 02215 | — |
| Sepctrum Health Medical Center /ID# 159522 | Grand Rapids | Michigan | 49503 | — |
| Columbia Univ Medical Center /ID# 154101 | New York | New York | 10032-3725 | — |
| Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077 | New York | New York | 10065-6007 | — |
| Duke Cancer Center /ID# 154106 | Durham | North Carolina | 27710-3000 | — |
| University of Pittsburgh MC /ID# 154102 | Pittsburgh | Pennsylvania | 15260 | — |
| Tennessee Oncology-Nashville Centennial /ID# 200854 | Nashville | Tennessee | 37203-1632 | — |
| University of Texas MD Anderson Cancer Center /ID# 154100 | Houston | Texas | 77030 | — |
| Baylor Scott & White Medical Center- Temple /ID# 157191 | Temple | Texas | 76508-0001 | — |
| University of Utah /ID# 157192 | Salt Lake City | Utah | 84112-5500 | — |
| University Of Vermont Medical /ID# 157196 | Burlington | Vermont | 05405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 148 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02993523, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02993523 live on ClinicalTrials.gov.