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NCT03761056 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma
A Phase 2 study, sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT03761056: Completed Phase 2 study, sponsored by Kite, A Gilead Company.
NCT03761056 is a Phase 2 study that has completed, run by Kite, A Gilead Company. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03761056, a Phase 2 study, has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.
Primary Outcome
CR Rate is the percentage of participants with CR (complete metabolic response (CMR); complete radiological response (CRR)). CMR: positron emission tomography (PET) 5-point scale (5-PS) scores of 1 (no uptake above background), 2 (uptake ≤ mediastinum), 3 (uptake \> mediastinum but ≤ liver) with/without a residual mass); no new lesions; and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow (BM). CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Axicabtagene Ciloleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 2 |
What the finished NCT03761056 record still lists
NCT03761056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03761056 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03761056 about?
NCT03761056 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Axicabtagene Ciloleucel as First-Line Therapy in Participants With High-Risk Large B-Cell Lymphoma". The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in participants with high-risk large B-cell lymphoma. After the end of KTE-C19-112 (ZUMA-12), participants who received an infusion of axicabtagene ciloleucel will complete the remainder of the 15-year follow...
What is the current status of trial NCT03761056?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-01-29. Estimated completion is 2023-10-12.
What interventions are being tested in trial NCT03761056?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03761056?
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 NCT03761056's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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