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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope /ID# 154105 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (172 Sites)
Showing the first 25 of 172 sites.
- City of Hope /ID# 154105 — Duarte, California
- University of California, Los Angeles /ID# 154107 — Los Angeles, California
- University of California, Davis Comprehensive Cancer Center /ID# 162725 — Sacramento, California
- Emory Midtown Infectious Disease Clinic /ID# 162534 — Atlanta, Georgia
- Northwestern University Feinberg School of Medicine /ID# 201133 — Chicago, Illinois
- University of Chicago Medicine /ID# 154108 — Chicago, Illinois
- Fort Wayne Medical Oncology /ID# 157190 — Fort Wayne, Indiana
- Cotton-O'Neil Clinical Res Ctr /ID# 155136 — Topeka, Kansas
- Norton Cancer Institute /ID# 154992 — Louisville, Kentucky
- EMMC Cancer Care /ID# 154991 — Brewer, Maine
- Johns Hopkins University /ID# 154104 — Baltimore, Maryland
- Massachusetts General Hospital /ID# 200752 — Boston, Massachusetts
- Beth Israel Deaconess Medical Center /ID# 201155 — Boston, Massachusetts
- Dana-Farber Cancer Institute /ID# 167009 — Boston, Massachusetts
- Sepctrum Health Medical Center /ID# 159522 — Grand Rapids, Michigan
- Columbia Univ Medical Center /ID# 154101 — New York, New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 165077 — New York, New York
- Duke Cancer Center /ID# 154106 — Durham, North Carolina
- University of Pittsburgh MC /ID# 154102 — Pittsburgh, Pennsylvania
- Tennessee Oncology-Nashville Centennial /ID# 200854 — Nashville, Tennessee
- University of Texas MD Anderson Cancer Center /ID# 154100 — Houston, Texas
- Baylor Scott & White Medical Center- Temple /ID# 157191 — Temple, Texas
- University of Utah /ID# 157192 — Salt Lake City, Utah
- University Of Vermont Medical /ID# 157196 — Burlington, Vermont
- Princess Alexandra Hospital /ID# 154272 — Woolloongabba, Queensland
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Acute Myeloid Leukemia (AML)
- A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant — New York, New York
- Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN — Boston, Massachusetts
- A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia — Duarte, California
- Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations — Duarte, California
- Study of Monzosertib In Patients With R/R AML Or High-Risk Myelodysplastic Syndrome — Houston, Texas
Explore by condition: All Acute Myeloid Leukemia (AML) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.