Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel (NCT04514029) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel
United States37 participantsStarted 2020-08-06
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18- 80 years of age
* One of the following histologies:
* Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
* Primary mediastinal B-cell lymphoma, or
* High grade B-cell lymphoma, or
* DLBCL arising from follicular lymphoma
* Disease status:
* Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
* Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
* Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy
* Performance Status
* ECOG performance status 0-2
* Adequate organ function defined as:
* Renal function defined as:
* eGFR ≥ 30 mL/min/1.73 m\^2
* Liver function defined as:
* ALT and AST ≤ 5 times the ULN for age (unless due to disease)
* Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
* Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
* Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol.
* Able to provide written voluntary consent (or LAR consent for adults with diminished capac…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients completing two-thirds of their assigned treatment
Timeframe: 30 days after initiation of CAR-T therapy
2
Number of patients experiencing adverse events
Timeframe: From the day of 1st dose of simvastatin and until day +7 after the last dose of simvastatin.
Trial details
NCT IDNCT04514029
SponsorMasonic Cancer Center, University of Minnesota