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NCT05605899 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma
A Phase 3 study of High-risk Large B-cell Lymphoma (LBCL), sponsored by Kite, A Gilead Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT05605899: Recruiting Phase 3 study of High-risk Large B-cell Lymphoma (LBCL), sponsored by Kite, A Gilead Company.
NCT05605899 is a Phase 3 study of High-risk Large B-cell Lymphoma (LBCL) that is actively recruiting participants, run by Kite, A Gilead Company. The registered enrollment target is 300 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05605899, a Phase 3 study of High-risk Large B-cell Lymphoma (LBCL), is actively recruiting participants, sponsored by Kite, A Gilead Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
Primary Outcome
EFS, is defined as the time from randomization to the earliest occurrence of death due to any cause, disease progression/relapse, initiation of any non-protocol specified subsequent new lymphoma therapy for the treatment of residual disease or Biopsy-proven residual disease at the Month 6 disease assessment or later, regardless of whether subsequent new lymphoma therapy is initiated or not.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Etoposide
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (20)
California
- UC San Diego Moores Cancer Center - La Jolla
- University of California Los Angeles (UCLA) - Los Angeles
- Stanford Cancer Institute - Palo Alto
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Mayo Clinic - Phoenix
Illinois
- Northwestern Memorial Hospital - Chicago
- University of Chicago Medical Center - Chicago
Alabama
- University of Alabama Hospital - Birmingham
Colorado
- Colorado Blood Cancer Institute - Denver
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-02-10 |
| Est. Completion | 2031-03 |
| Phase | Phase 3 |
What NCT05605899 shows while recruiting
NCT05605899 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (61% lower).
The record links to 1 condition, with High-risk Large B-cell Lymphoma (LBCL) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05605899 names 20 study sites across 16 states, led by California, Arizona, Illinois.
Frequently Asked Questions
What is clinical trial NCT05605899 about?
NCT05605899 is a clinical study titled "Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma". The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.
What is the current status of trial NCT05605899?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-02-10. Estimated completion is 2031-03.
What conditions does trial NCT05605899 study?
This clinical trial studies the following conditions: High-risk Large B-cell Lymphoma (LBCL).
What interventions are being tested in trial NCT05605899?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Etoposide (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT05605899?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05605899 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05605899's enrollment target sits among peer trials
300 1123rd of 2000 higher than 840 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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