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NCT02614066 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 125
- Enrollment target
NCT02614066: Completed Phase 1 study, sponsored by Kite, A Gilead Company.
NCT02614066 is a Phase 1 study that has completed, run by Kite, A Gilead Company. The registered enrollment target is 125 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02614066, a Phase 1 study, has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 125 participants
- Enrollment target
Study Summary
The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).
Primary Outcome
DLT is drug-related events with onset within first 28 days following infusion: * Grade (GR) 4 hematologic toxicity lasting more than 30 days (except lymphopenia) if not attributable to underlying disease * All drug-related GR 3 lasting for \> 7 days or 4 non-hematologic toxicities regardless of duration (except: aphasia/dysphasia or confusion/cognitive disturbance which resolves to at least GR 1/baseline within 2 weeks or baseline within 4 weeks, fever GR 3/ 4, immediate hypersensitivity reacti
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL brexucabtagene autoleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2016-03-07 |
| Est. Completion | 2023-11-03 |
| Phase | Phase 1 |
What the finished NCT02614066 record still lists
NCT02614066 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02614066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02614066 about?
NCT02614066 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)". The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).
What is the current status of trial NCT02614066?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2016-03-07. Estimated completion is 2023-11-03.
What interventions are being tested in trial NCT02614066?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), brexucabtagene autoleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT02614066?
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 NCT02614066's enrollment target sits among peer trials
125 467th of 2000 higher than 1,530 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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