A phase 2 open-label, multicenter study evaluating the safety and efficacy of axicabtagene ciloleucel concomitant with prophylactic steroids in subjects with relapsed or refractory large b-cell lymphoma in the outpatient setting

UVA Tracking #
HSR230125
Principal Investigator
Indumathy Varadarajan
Contact
Contact Phone
Official Trial Title
A phase 2 open-label, multicenter study evaluating the safety and efficacy of axicabtagene ciloleucel concomitant with prophylactic steroids in subjects with relapsed or refractory large b-cell lymphoma in the outpatient setting
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with relapsed or refractory large b-cell lymphoma (LBLC) for a research study. The study product, KTE-C19, has demonstrated to be safe and effective when combined with prophylactic steroids in treating relapsed or refractory LBLC. The purpose of this study is to find out if the product, KTE-C19, is equally safe and effective when in the outpatient setting.

The study treatment would involve removing some of your immune cells, genetically engineering those cells to identify cancer, receiving additional therapy while you wait for those cells to be released, and then infusing those cells back and assessing the effect on your cancer cells. These procedures will be carried out at the outpatient clinic. In addition to receiving the study treatment you would need to come in for study visits, which include exams, laboratory tests, having your blood drawn, and talking to the study doctor. Participation would include a screening period, a procedure called leukapheresis to collect your immune cells, a conditioning chemotherapy period 5 days prior to receiving the study treatment, an assessment period for 7 days after receiving the study treatment, and a follow up period for three months.

The study product, KTE-C19, as well as all study-related procedures including doctor's visits and laboratory tests, will be provided at no cost to you.
More information about this study can be found at https://clinicaltrials.gov/ct2/show/NCT05459571?term=ZUMA-24&draw=2&ran…

uvacancertrials@hscmail.mcc.virginia.edu

Reimbursement - $100 per visit
Hotel Reimbursement – up to $175

Compensation

No Compensation