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NCT04524455 · ClinicalTrials.gov registry record · Phase 1
Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL
A Phase 1 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04524455: Completed Phase 1 study, sponsored by Amgen.
NCT04524455 is a Phase 1 study that has completed, run by Amgen. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524455, a Phase 1 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.
Primary Outcome
Investigators determined whether an adverse event (AE) qualified as a DLT per pre-specified protocol defined criteria. An AE was defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment.
Interventions
- DRUG Blinatumomab
- DRUG AMG 404
- DRUG Dexamethasone Premedication
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-10-02 |
| Est. Completion | 2023-01-24 |
| Phase | Phase 1 |
What the finished NCT04524455 record still lists
NCT04524455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Blinatumomab is the first listed.
NCT04524455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04524455 about?
NCT04524455 is a clinical study titled "Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL". The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusi...
What is the current status of trial NCT04524455?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2020-10-02. Estimated completion is 2023-01-24.
What interventions are being tested in trial NCT04524455?
The interventions under investigation include: Blinatumomab (DRUG), AMG 404 (DRUG), Dexamethasone Premedication (DRUG).
Who is sponsoring clinical trial NCT04524455?
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 NCT04524455's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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