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NCT04314843 · ClinicalTrials.gov registry record · Phase 1
Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT04314843: Clinical Trial Phase 1 study, sponsored by Kite, A Gilead Company.
NCT04314843 is a Phase 1 study that was terminated before completion, run by Kite, A Gilead Company. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04314843, a Phase 1 study, was terminated before completion, sponsored by Kite, A Gilead Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2. Phase 2: To evaluate the incidence of neurologic events with sequenced therapy given at the recommended Phase 2 dose (RP2D) of lenzilumab in participants with relapsed or refractory large B-cell lymphoma.
Primary Outcome
A DLT was defined as the following sequenced therapy-related events with onset within the first 28 days following lenzilumab and axicabtagene ciloleucel infusions: * Grade 4 neutropenia lasting longer than 21 days from the day of cell transfer * Grade 4 thrombocytopenia lasting longer than 28 days from the day of cell transfer * Any sequenced therapy-related AE requiring intubation, including Grade 4 encephalopathy requiring intubation for airway protection * Any sequenced therapy-related Grade
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
- BIOLOGICAL Lenzilumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2022-07-27 |
| Phase | Phase 1 |
Why NCT04314843 stopped before completion
NCT04314843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT04314843 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04314843 about?
NCT04314843 is a clinical study titled "Study of Lenzilumab and Axicabtagene Ciloleucel in Participants With Relapsed or Refractory Large B-Cell Lymphoma". The primary objectives of this study are: Phase 1: To evaluate the safety of sequenced therapy with lenzilumab and axicabtagene ciloleucel in participants with relapsed or refractory large B-cell lymphoma and identify the most appropriate dose of lenzilumab for Phase 2. Phase 2: To evaluate the in...
What is the current status of trial NCT04314843?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2020-05-26. Estimated completion is 2022-07-27.
What interventions are being tested in trial NCT04314843?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL), Lenzilumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04314843?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04314843's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 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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