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Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel
Sponsor: Masonic Cancer Center, University of Minnesota
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
Simvastatin
Simvastatin 40 mg started 2 weeks (+/-5 days) prior to apheresis through day +30
Dexamethasone
Intrathecal dexamethasone 8 mg on days -1, +6, +13 (+/-2 days)
Locations (1)
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States