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NCT03154827 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)
A Phase 1 study, sponsored by BioLineRx.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03154827: Clinical Trial Phase 1 study, sponsored by BioLineRx.
NCT03154827 is a Phase 1 study that was terminated before completion, run by BioLineRx. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03154827, a Phase 1 study, was terminated before completion, sponsored by BioLineRx.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study The main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of BL-8040 and Atezolizumab as Maintenance Treatment in Subjects with Acute Myeloid Leukemia. Additional objectives are: Assessment of the effect of combination of BL-8040 and Atezolizumab on relapse free survival (RFS) Assessment whether the treatment combination of BL-8040 and Atezolizumab can reduce the Minimal Residual Disease (MRD) as compared to baseline Assessment of the Overall Survival (OS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance Assessment of the Event Free Survival (EFS) time in subjects treated with the combination of BL-8040 and Atezolizumab for maintenance
Primary Outcome
Relapse Free Survival measured from the time of Complete Remission to the relapse or death from any cause whichever comes first
Interventions
- DRUG Atezolizumab
- DRUG BL-8040
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-01-08 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 1 |
Why NCT03154827 stopped before completion
NCT03154827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Atezolizumab is the first listed.
NCT03154827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03154827 about?
NCT03154827 is a clinical study titled "Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab for Maintenance Treatment in Subjects With Acute Myeloid Leukemia (AML)". A Phase Ib/II, Multicenter, Single Arm, Open-Label Study, To Evaluate the Safety, Tolerability and Efficacy of the BL-8040 and Atezolizumab Combination for Maintenance Treatment in Subjects with Acute Myeloid Leukemia- The BATTLE Study The main goal of this clinical trial is to assess the safety an...
What is the current status of trial NCT03154827?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2018-01-08. Estimated completion is 2020-04-01.
What interventions are being tested in trial NCT03154827?
The interventions under investigation include: Atezolizumab (DRUG), BL-8040 (DRUG).
Who is sponsoring clinical trial NCT03154827?
This trial is sponsored by BioLineRx, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03154827's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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