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NCT04514029 · ClinicalTrials.gov registry record · Early Phase 1
Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel
A Early Phase 1 study of Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota.
- Active
- Registry status
- Early Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04514029 is a Early Phase 1 study of Lymphoma that is active but no longer recruiting, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 37 participants, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04514029, a Early Phase 1 study of Lymphoma, is active but no longer recruiting, sponsored by Masonic Cancer Center, University of Minnesota.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
Open-label, single-arm, single center pilot study to assess safety and feasibility of administering dexamethasone intrathecally and simvastatin orally during axicabtagene ciloleucel (axi-cel) treatment. Feasibility will be measured by the proportion of patients completing two-thirds (2/3) of their assigned treatments. The study will be deemed feasible if 2/3 or more of the patients complete 2/3 or more of their allocated treatments.
Conditions Studied
Interventions
- DRUG Dexamethasone
- DRUG Simvastatin
Study Locations (1)
Minnesota
- Masonic Cancer Center, University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04514029
The ClinicalTrials.gov registry entry for NCT04514029 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which Dexamethasone is the first listed.
NCT04514029 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT04514029 about?
NCT04514029 is a clinical study titled "Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel". Open-label, single-arm, single center pilot study to assess safety and feasibility of administering dexamethasone intrathecally and simvastatin orally during axicabtagene ciloleucel (axi-cel) treatment. Feasibility will be measured by the proportion of patients completing two-thirds (2/3) of their a...
What is the current status of trial NCT04514029?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 37 participants. The study started on 2020-08-06. Estimated completion is 2026-12.
What conditions does trial NCT04514029 study?
This clinical trial studies the following conditions: Lymphoma.
What interventions are being tested in trial NCT04514029?
The interventions under investigation include: Dexamethasone (DRUG), Simvastatin (DRUG).
Who is sponsoring clinical trial NCT04514029?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04514029 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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