Trials / Completed
CompletedNCT04102020
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
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Venetoclax | Tablet: Oral |
| DRUG | Azacitidine | Subcutaneous (SC) or intravenous (IV) injection |
| DRUG | Azacitidine | Oral Tablet |
Timeline
- Start date
- 2020-03-26
- Primary completion
- 2022-09-29
- Completion
- 2026-02-20
- First posted
- 2019-09-25
- Last updated
- 2026-04-08
- Results posted
- 2025-08-20
Locations
156 sites across 19 countries: United States, Australia, Canada, China, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Puerto Rico, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04102020. Inclusion in this directory is not an endorsement.