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 · VIALE-M Phase 3Completed
- Lead sponsor
- AbbVie (Industry)
- Enrollment
- 112 (actual)
- Start date
- 26 Mar 2020
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 20 Feb 2026
- Last update posted
- 8 Apr 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Non randomized
- Intervention model
- Sequential
- Masking
- None
- Arms
- 3
Interventions
- Venetoclax Drug
- Azacitidine Drug
Conditions and primary outcome
- Acute Myeloid Leukemia (AML)
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1) (Up to 28 days (Cycle 1)); Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion) (Up to 28 days (Cycle 1))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04102020 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
No primary outcome with a statistical analysis is posted for this study.
Serious adverse events
Time frame: All-cause mortality and adverse event tables include events reported from the time of informed consent to the interim cutoff date of 05OCT2022. The median time on follow-up was 446, 687, 389 days for Part 1 VEN400_AZA20, VEN400_AZA36, VEN400_AZA50 and 67.5, 275 days for Part 3 Dose Level 1 (VEN400_CC200), Dose Level 2 (VEN400_CC300), respectively.
| Group | Affected | At risk |
|---|---|---|
| Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2 | 5 | 23 |
| Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2 | 7 | 23 |
| Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2 | 5 | 20 |
| Part 3: Dose Level 1 - Venetoclax 400mg + CC-486 200mg | 5 | 30 |
| Part 3: Dose Level 2 - Venetoclax 400mg + CC-486 300mg | 3 | 16 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
2 on PubMedDesign of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia.
Future oncology (London, England) · 2022 Aug
PubMed 35852098 (opens in a new tab)DOI 10.2217/fon-2022-0450 (opens in a new tab)
Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission.
Current opinion in hematology · 2021 Mar 1
PubMed 33394722 (opens in a new tab)DOI 10.1097/MOH.0000000000000637 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04102020 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.