A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Completed · Phase 3

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Key facts

Study ID

NCT04102020

Run by

AbbVie

People needed

112

Starts

2020-03-26

Expected to finish

2026-02-20

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of newly diagnosed acute myeloid leukemia (AML).
• Participant meets the following disease activity criteria:
• Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
• Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
• AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
• Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

You may not qualify if…

• History of acute promyelocytic leukemia (APL).
• History of active central nervous system involvement with acute myeloid leukemia (AML).

Where it is running

• Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156 — Fountain Valley, California, United States
• University of California, Los Angeles /ID# 219149 — Los Angeles, California, United States
• Colorado Blood Cancer Institute /ID# 214280 — Denver, Colorado, United States
• St. Alphonsus Regional Medical /ID# 216424 — Boise, Idaho, United States
• Duplicate_Rush University Medical Center /ID# 218815 — Chicago, Illinois, United States
• University of Kentucky Markey Cancer Center /ID# 215048 — Lexington, Kentucky, United States
• Duplicate_Norton Cancer Institute /ID# 216401 — Louisville, Kentucky, United States
• Tulane Medical Center - New Orleans /ID# 218166 — New Orleans, Louisiana, United States
• Duplicate_Ochsner Clinic Foundation-New Orleans /ID# 214583 — New Orleans, Louisiana, United States
• Tufts Medical Center /ID# 216110 — Boston, Massachusetts, United States
• Massachusetts General Hospital /ID# 217307 — Boston, Massachusetts, United States
• Duplicate_UMass Chan Medical School /ID# 218163 — Worcester, Massachusetts, United States
• Oncology Hematology Associates (OHA) - Springfield /ID# 216351 — Springfield, Missouri, United States
• Saint Louis University Cancer Center /ID# 218164 — St Louis, Missouri, United States
• The John Theurer Cancer /ID# 215191 — Hackensack, New Jersey, United States
• Rutgers Cancer Institute of New Jersey /ID# 239708 — New Brunswick, New Jersey, United States
• Weill Cornell Medical College /ID# 214847 — New York, New York, United States
• Providence Portland Medical Ct /ID# 216231 — Portland, Oregon, United States
• Fox Chase Cancer Center /ID# 239372 — Philadelphia, Pennsylvania, United States
• UPMC Hillman Cancer Ctr /ID# 214051 — Pittsburgh, Pennsylvania, United States
• Duplicate_Prisma Health Cancer Institute-Faris Road /ID# 216066 — Greenville, South Carolina, United States
• St Francis Cancer Center /ID# 216115 — Greenville, South Carolina, United States
• Gibbs Cancer Center & Research /ID# 216192 — Spartanburg, South Carolina, United States
• Tennessee Oncology-Nashville Centennial /ID# 218757 — Nashville, Tennessee, United States
• Mitchell Cancer Institute /ID# 216443 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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