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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

NCT04102020

CompletedPhase 3

Sponsor: AbbVie

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Venetoclax, Azacitidine, Azacitidine

Countries: United States, Australia, Canada, China, Czechia, France, Germany, Greece

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Locations (156)

Mobile, Alabama, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Denver, Colorado, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Kogarah, New South Wales, Australia
Liverpool, New South Wales, Australia
Nowra, New South Wales, Australia
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