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Dexamethasone + Simvastatin for Neurotoxicity After Lymphoma Treatment

Q: How many participants are being accepted for this research initiative?

Correct. According to the clinicaltrials.gov website, this medical experiment is currently enrolling volunteers; it was first posted on August 6th 2020 and recently revised on November 2nd 2022. 20 individuals will be accepted from 1 location.

Q: Is there currently availability for participants in this experiment?

According to records on clinicaltrials.gov, this medical experiment is still recruiting participants. The trial was initially created on August 6th 2020 and the information has been modified most recently as of November 2nd 2022.

Q: What are the targeted results of this clinical investigation?

In this trial, conducted over a 30 day period, the primary outcome being monitored is the number of patients with adverse events. Secondary outcomes include measuring changes in VEGF and PDGFR concentrations as well as evaluating overall best responses to CAR-T cell therapy using Lugano criteria.

Q: Is this clinical trial limited to those over 40 years of age or are younger individuals being accepted as well?

As specified by the eligibility criteria, applicants between 18 and 80 years of age are suitable for this trial. Additionally, there exists 381 trials specifically tailored to minors while 2097 focus on individuals over 65.

Q: Are enrollment opportunities still available for this research?

This trial is searching for 20 individuals with lymphoma between 18 and 80 years of age that meet the following criteria: 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 <a href="https://www.withpower.com/clinical-trials/follicular-lymphoma">follicular lymphoma</a>, 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), Performance Status ECOG performance status 0-2.

Q: What earlier investigations have focused on the efficacy of Simvastatin?

Currently, there are 588 ongoing Simvastatin trials, with 150 of them in Phase 3. Mishawaka, <a href="https://www.withpower.com/clinical-trials/indiana">Indiana</a> has the most active sites for this drug trial but 19128 other locations across the United States also have programs running.

Q: In which health conditions is Simvastatin typically prescribed?

Simvastatin has been clinically demonstrated to effectively alleviate ophthalmia, sympathetic symptoms, cerebrovascular dysfunctions, and branch retinal vein occlusion.

Phase < 1

Waitlist Available

Led By Joseph Maakaron, MD

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate organ function: Renal function (eGFR ≥ 30 mL/min/1.73 m^2), Liver function (ALT and AST ≤ 5 times the ULN for age (unless due to disease), Bilirubin ≤ 2.0 mg/dl with exceptions for patients with Gilbert syndrome), Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA

18- 80 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one day prior to infusion and at days +1,+6, and +13 post infusion

Awards & highlights

Study Summary

This trial is testing whether it is safe and feasible to give patients dexamethasone and simvastatin along with axicabtagene ciloleucel (a cancer treatment). Feasibility will be measured by whether patients are able to complete most of their treatments.

Who is the study for?

Adults aged 18-80 with certain types of lymphoma (like DLBCL) who haven't responded to at least two chemotherapy treatments can join. They must be able to have lumbar punctures, not be pregnant or breastfeeding, use contraception, and have stable major organ function. Those already on statins or with uncontrolled infections, heart issues, bleeding risks that can't be managed, active HIV/hepatitis B/C or CNS lymphoma cannot participate.Check my eligibility

What is being tested?

This study tests the safety and practicality of giving dexamethasone directly into the spinal fluid and simvastatin orally to patients undergoing axi-cel therapy for lymphoma. Success is if most patients complete most of their treatment without serious problems.See study design

What are the potential side effects?

Potential side effects include those related to dexamethasone such as increased blood sugar levels, mood swings, stomach ulcers; and simvastatin which may cause muscle pain or weakness, liver damage signs like yellowing skin/eyes; both drugs could also increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidneys, liver, and heart are functioning well enough for treatment.

Select...

I am between 18 and 80 years old.

Select...

My lymphoma is one of the specified types (DLBCL, primary mediastinal, high grade, or from follicular lymphoma).

Select...

I am able to get out of my bed or chair and move around.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one day prior to infusion and at days +1,+6, and +13 post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one day prior to infusion and at days +1,+6, and +13 post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and one day prior to infusion and at days +1,+6, and +13 post infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients completing two-thirds of their assigned treatment

Number of patients experiencing adverse events

Secondary outcome measures

Number of participants experiencing overall best response with CAR-T cell therapy

Number of participants experiencing severe NT

The change in IL-10 levels

+9 more

Side effects data

From 2015 Phase 3 trial • 33 Patients • NCT02030041

11%

Myalgia

100%

80%

60%

40%

20%

Study treatment Arm

Vitamin D and Placebo

Simvastatin and Placebo

Simvastatin and Vitamin D

Trial Design

1Treatment groups

Experimental Treatment

Group I: Simvastatin and DexamethasoneExperimental Treatment2 Interventions

Simvastatin 40 mg/day will be started at least 5 days prior to apheresis and will be continued until day +30 after infusion. Intrathecal dexamethasone 8 mg will be administered on days (related to CAR-T infusion) -1, +6, +13, (+/- 2 days).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Simvastatin

FDA approved

Dexamethasone

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

271 Previous Clinical Trials

14,588 Total Patients Enrolled

42 Trials studying Lymphoma

3,143 Patients Enrolled for Lymphoma

Joseph Maakaron, MDPrincipal InvestigatorMasonic Cancer Center, University of Minnesota

1 Previous Clinical Trials

11 Total Patients Enrolled

Media Library

Simvastatin Clinical Trial Eligibility Overview. Trial Name: NCT04514029 — Phase < 1

Lymphoma Research Study Groups: Simvastatin and Dexamethasone

Lymphoma Clinical Trial 2023: Simvastatin Highlights & Side Effects. Trial Name: NCT04514029 — Phase < 1

Simvastatin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04514029 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted for this research initiative?

"Correct. According to the clinicaltrials.gov website, this medical experiment is currently enrolling volunteers; it was first posted on August 6th 2020 and recently revised on November 2nd 2022. 20 individuals will be accepted from 1 location."

Answered by AI

Is there currently availability for participants in this experiment?

"According to records on clinicaltrials.gov, this medical experiment is still recruiting participants. The trial was initially created on August 6th 2020 and the information has been modified most recently as of November 2nd 2022."

Answered by AI

What are the targeted results of this clinical investigation?

"In this trial, conducted over a 30 day period, the primary outcome being monitored is the number of patients with adverse events. Secondary outcomes include measuring changes in VEGF and PDGFR concentrations as well as evaluating overall best responses to CAR-T cell therapy using Lugano criteria."

Answered by AI

Is this clinical trial limited to those over 40 years of age or are younger individuals being accepted as well?

"As specified by the eligibility criteria, applicants between 18 and 80 years of age are suitable for this trial. Additionally, there exists 381 trials specifically tailored to minors while 2097 focus on individuals over 65."

Answered by AI

Are enrollment opportunities still available for this research?

"This trial is searching for 20 individuals with lymphoma between 18 and 80 years of age that meet the following criteria: 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, 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), Performance Status ECOG performance status 0-2."

Answered by AI

What earlier investigations have focused on the efficacy of Simvastatin?

"Currently, there are 588 ongoing Simvastatin trials, with 150 of them in Phase 3. Mishawaka, Indiana has the most active sites for this drug trial but 19128 other locations across the United States also have programs running."

Answered by AI

In which health conditions is Simvastatin typically prescribed?

"Simvastatin has been clinically demonstrated to effectively alleviate ophthalmia, sympathetic symptoms, cerebrovascular dysfunctions, and branch retinal vein occlusion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel

2020. "Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04514029.

All > Toxicity