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NCT03069352 · ClinicalTrials.gov registry record · Phase 3
A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 211
- Enrollment target
NCT03069352: Completed Phase 3 study, sponsored by AbbVie.
NCT03069352 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 211 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03069352, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 211 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).
Primary Outcome
Overall survival is defined as the time from the date of randomization to the date of death. Participants who had not died were censored at the date they were last known to be alive on or before the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.
Interventions
- DRUG Venetoclax
- DRUG Placebo
- DRUG Cytarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2017-05-23 |
| Est. Completion | 2025-08-21 |
| Phase | Phase 3 |
What the finished NCT03069352 record still lists
NCT03069352 is an interventional study that assigns participants to a tested intervention. The registered 211 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 (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03069352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03069352 about?
NCT03069352 is a clinical study titled "A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy". The primary objective of this study is to evaluate if venetoclax when co administered with low-dose cytarabine (LDAC) improves overall survival (OS) versus LDAC and placebo, in treatment-naïve patients with acute myeloid leukemia (AML).
What is the current status of trial NCT03069352?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2017-05-23. Estimated completion is 2025-08-21.
What interventions are being tested in trial NCT03069352?
The interventions under investigation include: Venetoclax (DRUG), Placebo (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT03069352?
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 NCT03069352's enrollment target sits among peer trials
211 1337th of 2000 higher than 663 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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