Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that was terminated before completion, run by AbbVie. The registered enrollment target is 465 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04161885
The ClinicalTrials.gov registry entry for NCT04161885 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 465 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT04161885 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.