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NCT04161885 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by AbbVie.
- Terminated
- Registry status
- Phase 3
- Development phase
- 465
- Enrollment target
NCT04161885: Clinical Trial Phase 3 study, sponsored by AbbVie.
NCT04161885 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 465 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04161885, a Phase 3 study, was terminated before completion, sponsored by AbbVie.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 465 participants
- Enrollment target
Study Summary
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 of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).
Primary Outcome
DLTs were any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.
Interventions
- DRUG Venetoclax
- DRUG Azacitidine
- OTHER Best Supportive Care (BSC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2020-02-26 |
| Est. Completion | 2025-09-23 |
| Phase | Phase 3 |
Why NCT04161885 stopped before completion
NCT04161885 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04161885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04161885 about?
NCT04161885 is a clinical study titled "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)". 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 transplanta...
What is the current status of trial NCT04161885?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2020-02-26. Estimated completion is 2025-09-23.
What interventions are being tested in trial NCT04161885?
The interventions under investigation include: Venetoclax (DRUG), Azacitidine (DRUG), Best Supportive Care (BSC) (OTHER).
Who is sponsoring clinical trial NCT04161885?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04161885's enrollment target sits among peer trials
465 819th of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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