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NCT04880434 · ClinicalTrials.gov registry record · Phase 2
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)
A Phase 2 study of Relapsed/Refractory Mantle Cell Lymphoma, sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 20
- Study locations
NCT04880434: Completed Phase 2 study of Relapsed/Refractory Mantle Cell Lymphoma, sponsored by Kite, A Gilead Company.
NCT04880434 is a Phase 2 study of Relapsed/Refractory Mantle Cell Lymphoma that has completed, run by Kite, A Gilead Company. The registered enrollment target is 95 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04880434, a Phase 2 study of Relapsed/Refractory Mantle Cell Lymphoma, has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Primary Outcome
OR: complete metabolic response (CMR),complete radiological response (CRR), partial MR response (PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤mediastinum)/3(uptake \>mediastinum but ≤liver) with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤1.5cm in longest transverse diameter of lesion (LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Brexucabtagene autoleucel
Study Locations (20)
Illinois
- University of Chicago - Chicago
- Loyola University Medical Center - Maywood
- Advocate Aurora Health - Advocate Lutheran General Hospital - Park Ridge
California
- Stanford University - Palo Alto
- University California Los Angeles (UCLA) - Santa Monica
Florida
- University of Miami - Miami
- Moffitt Cancer Center - Tampa
Ohio
- Cleveland Clinic - Taussig Cancer Institute - Cleveland
- Ohio State University - Columbus
Tennessee
- Sarah Cannon - Tenessee - Nashville
- Vanderbilt University - Nashville
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Colorado
- Sarah Cannon- Denver - Denver
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2021-04-27 |
| Est. Completion | 2025-06-17 |
| Phase | Phase 2 |
What the finished NCT04880434 record still lists
NCT04880434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Relapsed/Refractory Mantle Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04880434 names 20 study sites across 14 states, led by Illinois, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04880434 about?
NCT04880434 is a clinical study titled "Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)". The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
What is the current status of trial NCT04880434?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 2021-04-27. Estimated completion is 2025-06-17.
What conditions does trial NCT04880434 study?
This clinical trial studies the following conditions: Relapsed/Refractory Mantle Cell Lymphoma.
What interventions are being tested in trial NCT04880434?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Brexucabtagene autoleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT04880434?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04880434 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04880434's enrollment target sits among peer trials
95 759th of 2000 higher than 1,237 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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