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Siltuximab for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Led By Timothy J Voorhees, MD, MSCR
Research Sponsored by Timothy Voorhees
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible for standard of care CD19.CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel and lisocabtagene maraleucel)
FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of treatment initiation to date of death due to all causes, assessed up to 1 year
Awards & highlights
Study Summary
This trial tests if siltuximab can help reduce complications of CD19.CAR-T cell therapy.
Who is the study for?
Adults with CD19 positive non-Hodgkin lymphoma eligible for standard CAR-T cell therapy can join this trial. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have active central nervous system lymphoma or uncontrolled illnesses.Check my eligibility
What is being tested?
The trial is testing siltuximab's ability to prevent cytokine release syndrome (CRS) and neurotoxicity in patients undergoing CAR-T cell therapy. Siltuximab is an antibody that targets IL-6, a body chemical linked to these side effects.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response such as inflammation in various organs due to the suppression of IL-6 by siltuximab. Specific side effect profiles will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am eligible for a specific CAR-T cell therapy.
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I have a reaction of grade 2 or higher after CAR-T cell therapy.
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I have had mild brain side effects from treatment for more than 12 hours.
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I am 18 years old or older.
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I am a male and will use effective birth control during and for 12 months after the study.
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I have been diagnosed with non-Hodgkin lymphoma.
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My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.
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I have a reaction of grade 2 or higher after CAR-T cell therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of treatment initiation to date of death due to all causes, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of treatment initiation to date of death due to all causes, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and nature of adverse events associated with siltuximab prophylaxis prior to CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) cell therapy
Secondary outcome measures
Frequency and nature of adverse events associated with siltuximab treatment of cytokine release syndrome (CRS) and/or immune effector cell associated neurotoxicity syndrome (ICANS)
Incidence of all grade CRS and grade >= 3 CRS
Incidence of all grade ICANS and grade >= 3 ICANS
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (siltuximab, biospecimen)Experimental Treatment4 Interventions
Patients receive siltuximab IV prior to CE19.CAR-T cell therapy and as clinically indicated on study. Patients undergo CT scan or PET scan throughout the trial. Patients also undergo blood sample collection during screening and on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Positron Emission Tomography
2008
Completed Phase 2
~2240
Siltuximab
2011
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
Timothy VoorheesLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
Timothy J Voorhees, MD, MSCRPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for a specific CAR-T cell therapy.I am 18 years old or older.I do not have active brain conditions like epilepsy, severe strokes, or Parkinson's.I had a severe reaction to my first siltuximab infusion.I am not able to become pregnant due to surgery or being postmenopausal for over a year.I do not have any severe uncontrolled illnesses like heart failure or very high blood pressure.I have had severe side effects from siltuximab treatment before.I have had mild brain side effects from treatment for more than 12 hours.I agree to use two effective birth control methods or abstain from sex for 12 months after my last dose.I am a male and will use effective birth control during and for 12 months after the study.I have a reaction of grade 2 or higher after CAR-T cell therapy.I have been diagnosed with non-Hodgkin lymphoma.My blood tests are mostly normal and any changes won't count as side effects unless they require a change in my treatment.I have hepatitis C but my viral load is undetectable.My cancer can be measured and is larger than 1.5 cm or is in my bone marrow.I have CRS without ICANS and need steroids as decided by my doctors.I need a steroid for my severe CRS and have no signs of ICANS.I am HIV positive.I am a woman who can have children and have a recent negative pregnancy test.I have a reaction of grade 2 or higher after CAR-T cell therapy.I received a siltuximab dose for CRS/ICANS and saw no improvement in 12 hours.I have another cancer that won't affect this trial's treatment.I take more than 10mg of prednisone daily, except for short-term high doses.I am scheduled to receive steroids to prevent side effects from a specific cancer treatment.My lymphoma has not spread to my brain or spinal cord, or if it has, it's been in remission for at least 3 months.I have hepatitis B but am on treatment and my viral load is undetectable.I am willing and able to follow the study's procedures.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (siltuximab, biospecimen)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts still underway for this research endeavor?
"Unfortunately, the information on clinicaltrials.gov clarifies that this medical trial is not currently recruiting patients. Initially posted in January 1st of 2023 and last edited December 16th 2022, it has stopped enrolling applicants at this time; yet there are 1800 other trials actively seeking participants."
Answered by AI
Has the FDA sanctioned siltuximab and its associated biospecimen for medical use?
"Our team at Power gauges the safety of Treatment (siltuximab, biospecimen) to be a 1 on a scale from 1-3 due to it being in Phase 1 trials. Thus, there is only limited evidence that suggests its efficacy and safety."
Answered by AI
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