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Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Biospecimen Collection
Computed Tomography
Positron Emission Tomography
Siltuximab
Sponsored by
Timothy Voorhees
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Age >= 18 years at the time of consent Diagnosis of non-Hodgkin lymphoma Eligible for standard of care CD19.CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel and lisocabtagene maraleucel) Subjects with hepatitis B virus (HBV) can be included if on suppressive antiviral therapy and have no detectable viral load Subjects with hepatitis C virus (HCV) can be included if HCV ribonucleic acid (RNA) viral load is undetected Measurable disease of > 1.5 cm in diameter and/or bone marrow involvement White blood cell count >= 1.0 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Hemoglobin >= 8.0 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Platelets >= 50 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Creatinine =< 2.0 x upper limit of normal (ULN) (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Bilirubin =< 2.0 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level > 2.0 mg/dL if their conjugated bilirubin is =< 2.0 × ULN) (obtained within 14 days prior to initiating study treatment) Aspartate aminotransferase (AST) =< 3.0 × ULN (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Alanine aminotransferase (ALT) =< 3.0 × ULN (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of siltuximab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of siltuximab Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade 1 ICANS lasting > 12 hours FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy with concurrent ICANS SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Subjects meeting criteria for a treatment dose who have received a treatment dose and have no change in the CRS or ICANS grade after 12 hours Exclusion Criteria: Subjects requiring daily corticosteroids at a dose > 10mg of prednisone per day (orequivalent). Pulsed steroids for disease control are acceptable Subjects who are planned to receive prophylactic steroids for mitigating CRS/ICANS before, during, or after CD19.CAR-T infusion Active central nervous system or meningeal involvement by lymphoma. Subjects with symptoms of possible central nervous system (CNS) disease should undergo CNS workup with magnetic resonance imaging (MRI) brain and diagnostic lumbar puncture prior to enrollment on this study. Subjects with a history of CNS or meningeal involvement must be in a documented remission by cerebrospinal spinal fluid (CSF) evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration Patients with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease Human immunodeficiency virus (HIV) seropositivity Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs) Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non compensated hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 120mmHg) FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Subjects with CRS and no evidence of ICANS who require dexamethasone (or any steroid) due to severity of CRS as determined by the investigators FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Prior history of a dose limiting toxicity (see section 6.5) due to siltuximab infusion according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) criteria v5.0 SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Subjects with CRS and no evidence of ICANS who require dexamethasone (or any steroid) due to severity of CRS as determined by the investigators SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Prior history of a dose limiting toxicity due to siltuximab infusion according to NCI-CTCAE criteria v5.0

Sites / Locations

  • Ohio State University Comprehensive Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (siltuximab, biospecimen)

Arm Description

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.

Outcomes

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
Adverse events (AEs) will be described and classified per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events. The AE data associated with prophylaxis will be summarize for every patient: for patients receiving siltuximab only as prophylaxis, all AEs occur during the 30-day dose limiting toxicity observation period will be considered; for patients receiving siltuximab both as prophylaxis and as treatment, only the AEs occur before the treatment start will be considered for the primary endpoint.

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)
AEs will be described and classified per the NCI CTCAE v5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events. AEs post treatment start will be summarized for the secondary endpoint.
Incidence of all grade CRS and grade >= 3 CRS
According to American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Incidence of all grade ICANS and grade >= 3 ICANS
According to ASTCT consensus grading criteria.
Percentage of participants who achieve resolution of CRS
Defined as absence of symptoms leading to diagnosis of CRS.
Objective response rate (complete response [CR] + partial response [PR])
The ORR (CR + PR) will be calculated at the initial 30 day imaging assessment and 95% confidence interval computed.
Progression free survival
Will be estimated using the Kaplan-Meier method.
Overall survival
Will be estimated using the Kaplan-Meier method.

Full Information

First Posted
December 16, 2022
Last Updated
March 8, 2023
Sponsor
Timothy Voorhees
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1. Study Identification

Unique Protocol Identification Number
NCT05665725
Brief Title
Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma
Official Title
Phase I Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy Voorhees

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase I trial tests the safety and side effects of siltuximab in preventing CAR T cell therapy related cytokine release syndrome in patients with CD19 positive non-Hodgkin lymphoma. Several of the major complications of CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) include cytokine release syndrome (CRS, a complication of a highly active immune system seen with some cancer treatments including CD19.CAR-T cell therapy) and immune effector cell therapy associated neurotoxicity (ICANS, neurologic complications related to an activated immune system seen with immunotherapy and CD19.CAR-T cell therapy). Siltuximab is a chimeric (having parts of different origins) murine (from mice) antibody that binds directly to IL-6 (a cytokine/ body chemical causing toxicities) and allows for its clearance. IL-6 is known to increase in a patient's blood after CD19.CAR-T cell infusion and has been associated with development of CRS and ICANS. Giving siltuximab prior to CD19.CAR-T cell therapy may help reduce CRS and/or ICANS after therapy.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the safety of siltuximab when given prior to CD19.CAR-T cells for prevention of cytokine release syndrome associated CAR-T cell therapy. SECONDARY OBJECTIVES: I. To describe the safety profile of siltuximab as first line treatment of new onset grade >= 2 cytokine release syndrome (CRS). II. To estimate the incidence of all-grade CRS and grade >= 3 CRS after CAR-T cell therapy with siltuximab prophylaxis. III. To estimate the incidence of all grade immune effector cell associated neurotoxicity syndrome (ICANS) and grade >= 3 ICANS after CAR-T cell therapy with siltuximab prophylaxis. IV. To describe the response rates of grade >= 2 CRS to treatment with a second dose of siltuximab. V. To describe the disease response rates of lymphoma patients after CD19.CAR-T cell therapy with siltuximab prophylaxis. VI. To estimate the progression free survival (PFS) in subjects treated with CD19.CAR-T cell therapy with siltuximab prophylaxis. VII. To estimate the overall survival (OS) in subjects treated with CD19.CAR-T cell therapy with siltuximab prophylaxis. EXPLORATORY OBJECTIVES: I. To describe CD19.CAR-T cell expansion and persistence following treatment with siltuximab prophylaxis. II. To describe changes in plasma cytokine concentrations in patients treated with CD19.CAR-T cells with prophylactic siltuximab. III. To describe changes in peripheral blood immunophenotypes in patients treated with CD19.CAR-T cells with prophylactic siltuximab. IV. To examine the role of complement activation on development and persistence of ICANS. V. To examine the correlation between apheresis product, infusional CAR-T product, and pre-lymphodepletion immunophenotypes with CRS/ICANS and CD19.CAR- T clinical response. OUTLINE: Patients receive siltuximab intravenously (IV) prior to CE19.CAR-T cell therapy and as clinically indicated on study. Patients undergo computed tomography (CT) scan or positron emission tomography (PET) scan throughout the trial. Patients also undergo blood sample collection during screening and on study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment (siltuximab, biospecimen)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biospecimen Collected, Specimen Collection
Intervention Description
Undergo blood sample collection
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Intervention Description
Undergo CT scan
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Intervention Description
Undergo PET scan
Intervention Type
Biological
Intervention Name(s)
Siltuximab
Other Intervention Name(s)
Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, CNTO-328, Sylvant
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
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
Description
Adverse events (AEs) will be described and classified per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events. The AE data associated with prophylaxis will be summarize for every patient: for patients receiving siltuximab only as prophylaxis, all AEs occur during the 30-day dose limiting toxicity observation period will be considered; for patients receiving siltuximab both as prophylaxis and as treatment, only the AEs occur before the treatment start will be considered for the primary endpoint.
Time Frame
Up to 30 days after the last infusion of siltuximab
Secondary Outcome Measure Information:
Title
Frequency and nature of adverse events associated with siltuximab treatment of cytokine release syndrome (CRS) and/or immune effector cell associated neurotoxicity syndrome (ICANS)
Description
AEs will be described and classified per the NCI CTCAE v5.0 guidelines. The maximum grade of each type of toxicity will be extracted for each patient, and frequency counts will be tabulated to determine toxicity patterns, especially for grade 3 or above adverse events. AEs post treatment start will be summarized for the secondary endpoint.
Time Frame
Up to 30 days after the last infusion of siltuximab
Title
Incidence of all grade CRS and grade >= 3 CRS
Description
According to American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria.
Time Frame
Up to 30 days after the last infusion of siltuximab
Title
Incidence of all grade ICANS and grade >= 3 ICANS
Description
According to ASTCT consensus grading criteria.
Time Frame
Up to 30 days after the last infusion of siltuximab
Title
Percentage of participants who achieve resolution of CRS
Description
Defined as absence of symptoms leading to diagnosis of CRS.
Time Frame
At 24 hours from treatment
Title
Objective response rate (complete response [CR] + partial response [PR])
Description
The ORR (CR + PR) will be calculated at the initial 30 day imaging assessment and 95% confidence interval computed.
Time Frame
At day 30 following CD19.CAR-T cell therapy
Title
Progression free survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
From the date of treatment initiation to date of progression or death, whichever occurs first, assessed up to 1 year
Title
Overall survival
Description
Will be estimated using the Kaplan-Meier method.
Time Frame
From date of treatment initiation to date of death due to all causes, assessed up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information Age >= 18 years at the time of consent Diagnosis of non-Hodgkin lymphoma Eligible for standard of care CD19.CAR-T cell therapy including axicabtagene ciloleucel, tisagenlecleucel, brexucabtagene autoleucel and lisocabtagene maraleucel) Subjects with hepatitis B virus (HBV) can be included if on suppressive antiviral therapy and have no detectable viral load Subjects with hepatitis C virus (HCV) can be included if HCV ribonucleic acid (RNA) viral load is undetected Measurable disease of > 1.5 cm in diameter and/or bone marrow involvement White blood cell count >= 1.0 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Hemoglobin >= 8.0 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Platelets >= 50 x 10^9/L (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Creatinine =< 2.0 x upper limit of normal (ULN) (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Bilirubin =< 2.0 × upper limit of normal (ULN). Subjects with Gilbert's syndrome may be enrolled despite a total bilirubin level > 2.0 mg/dL if their conjugated bilirubin is =< 2.0 × ULN) (obtained within 14 days prior to initiating study treatment) Aspartate aminotransferase (AST) =< 3.0 × ULN (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Alanine aminotransferase (ALT) =< 3.0 × ULN (obtained within 14 days prior to initiating study treatment) Note: Hematology and other lab parameters that are =< grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to registration NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after treatment the last dose of siltuximab. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label Male subjects with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 12 months after the last dose of siltuximab Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the experimental regimen are eligible for the trial Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade 1 ICANS lasting > 12 hours FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Any subject with grade >= 2 CRS after CD19.CAR-T cell therapy with concurrent ICANS SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Subjects meeting criteria for a treatment dose who have received a treatment dose and have no change in the CRS or ICANS grade after 12 hours Exclusion Criteria: Subjects requiring daily corticosteroids at a dose > 10mg of prednisone per day (orequivalent). Pulsed steroids for disease control are acceptable Subjects who are planned to receive prophylactic steroids for mitigating CRS/ICANS before, during, or after CD19.CAR-T infusion Active central nervous system or meningeal involvement by lymphoma. Subjects with symptoms of possible central nervous system (CNS) disease should undergo CNS workup with magnetic resonance imaging (MRI) brain and diagnostic lumbar puncture prior to enrollment on this study. Subjects with a history of CNS or meningeal involvement must be in a documented remission by cerebrospinal spinal fluid (CSF) evaluation and contrast-enhanced MRI imaging for at least 90 days prior to registration Patients with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease Human immunodeficiency virus (HIV) seropositivity Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs) Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association (NYHA) Class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe non compensated hypertension (systolic blood pressure >= 180mmHg or diastolic blood pressure >= 120mmHg) FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Subjects with CRS and no evidence of ICANS who require dexamethasone (or any steroid) due to severity of CRS as determined by the investigators FOR SILTUXIMAB TREATMENT OF CRS/ICANS: Prior history of a dose limiting toxicity (see section 6.5) due to siltuximab infusion according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) criteria v5.0 SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Subjects with CRS and no evidence of ICANS who require dexamethasone (or any steroid) due to severity of CRS as determined by the investigators SECOND SILTUXIMAB TREATMENT DOSE FOR CRS/ICANS: Prior history of a dose limiting toxicity due to siltuximab infusion according to NCI-CTCAE criteria v5.0
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy J Voorhees, MD, MSCR
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy J. Voorhees, MD, MSCR
Phone
614-293-6943
Email
timothy.voorhees@osumc.edu
First Name & Middle Initial & Last Name & Degree
Timothy J. Voorhees, MD, MSCR

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

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Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma

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