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NCT04506086 · ClinicalTrials.gov registry record · Phase 4
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
A Phase 4 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT04506086: Clinical Trial Phase 4 study, sponsored by Amgen.
NCT04506086 is a Phase 4 study that was terminated before completion, run by Amgen. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506086, a Phase 4 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
Study Summary
The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
Primary Outcome
Adverse event were graded using the Common Terminology Criteria for Adverse Events, (CTCAE) v5.0 grading Scale. Grade 3 events were defined as severe or medically significant but not immediately life-threatening; grade 4 events were defined as life-threatening consequences; urgent intervention indicated. CSR is a heightened T-cell activation and release of pro inflammatory cytokines. NT signs include encephalopathy, delirium, aphasia, lethargy, difficulty concentrating, agitation, tremor, seizu
Interventions
- DRUG Blinatumomab
- DEVICE Current Wearable Heatlth Monitoring System (CWHMS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-26 |
| Est. Completion | 2024-09-16 |
| Phase | Phase 4 |
Why NCT04506086 stopped before completion
NCT04506086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Blinatumomab is the first listed.
NCT04506086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04506086 about?
NCT04506086 is a clinical study titled "Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)". The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).
What is the current status of trial NCT04506086?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2021-08-26. Estimated completion is 2024-09-16.
What interventions are being tested in trial NCT04506086?
The interventions under investigation include: Blinatumomab (DRUG), Current Wearable Heatlth Monitoring System (CWHMS) (DEVICE).
Who is sponsoring clinical trial NCT04506086?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04506086's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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