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Dexamethasone + Simvastatin for Neurotoxicity After Lymphoma Treatment

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

Must not have

Unstable angina and/or myocardial infarction

Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 60 Other Conditions

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.

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.

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

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

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I am between 18 and 80 years old.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a recent heart attack or unstable chest pain.

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I am not pregnant or breastfeeding and have a negative pregnancy test.

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I have an active HIV infection.

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I am taking a statin for high cholesterol and do not want to switch to simvastatin 40 mg/day.

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I can safely undergo a lumbar puncture without high risk.

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I do not have any severe, uncontrolled infections.

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I am experiencing moderate to severe symptoms from a transplant complication.

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I do not have uncontrolled hepatitis B or C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients completing two-thirds of their assigned treatment

Number of patients experiencing adverse events

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

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 / 12Eligibility criteria met