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NCT02601313 · ClinicalTrials.gov registry record · Phase 2
Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)
A Phase 2 study, sponsored by Kite, A Gilead Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT02601313: Completed Phase 2 study, sponsored by Kite, A Gilead Company.
NCT02601313 is a Phase 2 study that has completed, run by Kite, A Gilead Company. The registered enrollment target is 105 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02601313, a Phase 2 study, has completed, sponsored by Kite, A Gilead Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
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 ≤ 1.5 cm in longest transverse diameter of lesion(LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to n
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Axicabtagene Ciloleucel
- BIOLOGICAL brexucabtagene autoleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-11-09 |
| Est. Completion | 2023-09-22 |
| Phase | Phase 2 |
What the finished NCT02601313 record still lists
NCT02601313 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (21% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02601313 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02601313 about?
NCT02601313 is a clinical study titled "Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)". 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 NCT02601313?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2015-11-09. Estimated completion is 2023-09-22.
What interventions are being tested in trial NCT02601313?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Axicabtagene Ciloleucel (DRUG), brexucabtagene autoleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT02601313?
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 NCT02601313's enrollment target sits among peer trials
105 650th of 2000 higher than 1,341 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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