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A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Terminated · Phase 3 · NCT04161885

Conditions: Acute Myeloid Leukemia (AML), Cancer

At a glance

Research payments reported, 2025
$669,846
U.S. investigators named
32
Sites paid
30
Planned or actual enrollment
465

About the trial

Sponsor
AbbVie
Tested
Venetoclax (drug), Azacitidine (drug), Best Supportive Care (BSC) (other)
Dates
Started 2020-02-26; completion 2025-09-23
Results posted
Yes

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety …

From ClinicalTrials.gov, last updated 2026-06-04. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $669,846 in research payments for this study in 2025 (256 payments).

Products named: Venclexta

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.