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ACTIVE NOT RECRUITING
NCT04514029
EARLY_PHASE1

Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel

Sponsor: Masonic Cancer Center, University of Minnesota

View on ClinicalTrials.gov

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.

Official title: Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin in Adults Receiving Axicabtagene Ciloleucel (Axi-Cel) Treatment

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2020-08-06

Completion Date

2026-12

Last Updated

2026-01-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Simvastatin

Simvastatin 40 mg started 2 weeks (+/-5 days) prior to apheresis through day +30

DRUG

Dexamethasone

Intrathecal dexamethasone 8 mg on days -1, +6, +13 (+/-2 days)

Locations (1)

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States