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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: Active Early Phase 1 study of Lymphoma, sponsored by Masonic Cancer Center, University of Minnesota.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The feasibility of administering Simvastatin and Dexamethasone will be measured by the proportion of the patients completing two-thirds (2/3) of their assigned treatments.

Conditions Studied

Interventions

  • DRUG Dexamethasone
  • DRUG Simvastatin

Study Locations (1)

Minnesota

  • Masonic Cancer Center, University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2020-08-06
Est. Completion 2026-12
Phase Early Phase 1

What the registry record for NCT04514029 still lists

NCT04514029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 484-participant average among 299 other Lymphoma trials with a reported enrollment target (92% lower).

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 a single indexed study location in 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.

Similar trials for Lymphoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04514029's enrollment target sits among peer trials

37 191st of 299 higher than 108 of 299 other Lymphoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Lymphoma 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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Source: ClinicalTrials.gov NCT04514029, the US trial registry maintained by the National Library of Medicine. NCT04514029 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.