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NCT05371093 · ClinicalTrials.gov registry record · Phase 3
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
A Phase 3 study of Relapsed/Refractory Follicular Lymphoma, sponsored by Kite, A Gilead Company.
- Active
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
- 20
- Study locations
NCT05371093: Active Phase 3 study of Relapsed/Refractory Follicular Lymphoma, sponsored by Kite, A Gilead Company.
NCT05371093 is a Phase 3 study of Relapsed/Refractory Follicular Lymphoma that is active but no longer recruiting, run by Kite, A Gilead Company. The registered enrollment target is 231 participants, below the 621-participant average among 3 other Relapsed/Refractory Follicular Lymphoma trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05371093, a Phase 3 study of Relapsed/Refractory Follicular Lymphoma, is active but no longer recruiting, sponsored by Kite, A Gilead Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
- 20
- Study locations
Study Summary
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Primary Outcome
PFS is defined as the time from randomization to disease progression or death due to any cause.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Lenalidomide
- BIOLOGICAL Axicabtagene Ciloleucel
Study Locations (20)
Other
- Hopital Henri Mondor - Créteil
- CHU de Dijon - Dijon
- Hôpital Claude Huriez-CHU de Lille - Lille
- Institut Paoli-Calmettes - Marseille
- Hopital Saint Eloi - Montpellier
- Hopital Pitie-Salpetriere - Paris
- CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie - Pessac
- Centre Hospitalier Lyon Sud - Pierre-Bénite
California
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) - Duarte
- Stanford Health Care - Stanford
Tennessee
- TriStar Centennial Medical Center - Cell Processing - Nashville
- Henry-Joyce Cancer Clinic - Nashville
Florida
- Moffitt Cancer Center - Tampa
Kansas
- The University of Kansas Hospital - Westwood
Maryland
- University of Maryland Greenebaum Comprehensive Cancer Center - Baltimore
Massachusetts
- Dana-Farber Cancer Institute - Boston
North Carolina
- Novant Health Cancer Institute Hematology - Charlotte - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2022-09-22 |
| Est. Completion | 2030-10 |
| Phase | Phase 3 |
What the registry record for NCT05371093 still lists
NCT05371093 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 621-participant average among 3 other Relapsed/Refractory Follicular Lymphoma trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Relapsed/Refractory Follicular Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05371093 names 20 study sites across 11 states, led by Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05371093 about?
NCT05371093 is a clinical study titled "Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma". The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
What is the current status of trial NCT05371093?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2022-09-22. Estimated completion is 2030-10.
What conditions does trial NCT05371093 study?
This clinical trial studies the following conditions: Relapsed/Refractory Follicular Lymphoma.
What interventions are being tested in trial NCT05371093?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Axicabtagene Ciloleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT05371093?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05371093 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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