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NCT03624036 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
A Phase 1 study, sponsored by Kite, A Gilead Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03624036 is a Phase 1 study that was terminated before completion, run by Kite, A Gilead Company. The registered enrollment target is 16 participants.
The verdict
NCT03624036, a Phase 1 study, was terminated before completion, sponsored by Kite, A Gilead Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which must include a Bruton's tyrosine kinase (BTK) inhibitor. After the end of KTE-C19-108, participants who received an infusion of brexucabtagene autoleucel will complete the remainder of the 15-year follow-up assessments in a separate Long-term Follow-up study, KT-US-982-5968 (NCT05041309).
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL brexucabtagene autoleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2022-11-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03624036
The ClinicalTrials.gov registry entry for NCT03624036 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kite, A Gilead Company, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03624036 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03624036 about?
NCT03624036 is a clinical study titled "Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma". The primary objective of this study is to evaluate the safety and tolerability of brexucabtagene autoleucel (KTE-X19) in adults with relapsed/refractory chronic lymphocytic leukemia (r/r CLL) and small lymphocytic lymphoma (r/r SLL) who have received at least 2 prior lines of treatment, one of which...
What is the current status of trial NCT03624036?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-11-15. Estimated completion is 2022-11-18.
What interventions are being tested in trial NCT03624036?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), brexucabtagene autoleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03624036?
This trial is sponsored by Kite, A Gilead Company, which has 28 total clinical trials registered on ClinicalTrials.gov.
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