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NCT03391466 · ClinicalTrials.gov registry record · Phase 3
Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
A Phase 3 study, sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 359
- Enrollment target
NCT03391466: Completed Phase 3 study, sponsored by Kite, A Gilead Company.
NCT03391466 is a Phase 3 study that has completed, run by Kite, A Gilead Company. The registered enrollment target is 359 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03391466, a Phase 3 study, has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 359 participants
- Enrollment target
Study Summary
The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Primary Outcome
EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \> liver) or 5 (uptake markedly \> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \> 1.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
- DRUG Platinum-containing Salvage Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2018-01-25 |
| Est. Completion | 2024-11-25 |
| Phase | Phase 3 |
What the finished NCT03391466 record still lists
NCT03391466 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03391466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03391466 about?
NCT03391466 is a clinical study titled "Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma". The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
What is the current status of trial NCT03391466?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 359 participants. The study started on 2018-01-25. Estimated completion is 2024-11-25.
What interventions are being tested in trial NCT03391466?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL), Platinum-containing Salvage Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03391466?
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 NCT03391466's enrollment target sits among peer trials
359 1021st of 2000 higher than 979 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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