Phase
Condition
Multiple Myeloma
Bone Neoplasm
Platelet Disorders
Treatment
Siltuximab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients who are planned to receive chimeric antigen receptor T-cell therapy as perthe United States Food and Drug Agency (USFDA) approved indications for Diffuselarge B-cell lymphoma (DLBCL), Mantle cell lymphoma (MCL), Follicular lymphoma (FL),Primary mediastinal large B-cell lymphoma (PMBCL), High grade B-cell lymphoma, DLBCLarising from follicular lymphoma, Multiple myeloma and B-cell precursor acutelymphoblastic leukemia
Patients with hepatitis C virus (HCV) can be included if they have completed therapyfor hepatitis C with undetectable HCV RNA viral load.
Patients with Hepatitis B can be included if they are on suppressive therapy forhepatitis B infection and with no detectable viral load.
Adequate organ function as defined below unless attributed to diseaseinvolvement.Acceptable window for assessing adequate organ function is 7 days to 30days before planned CAR T-cell infusion with day 0 as the planned day of CAR T-cellinfusion.Adequate liver function (bilirubin < 2mg/dL, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <3 x ULN), adequate kidney function (crcl > 30ml/min using Cockcroft-Gault, based on actual weight) and adequatehematological parameters (Absolute neutrophil count ≥ 1,000/µL, Hemoglobin > 8,Platelet Count ≥ 50,000/ µL)
Patients able to tolerate washout periods for therapies prior to CAR T-cellinfusion. Systemic therapy: Washout period is 2 weeks prior to CAR T-cell infusion.Radiation therapy: Washout period is 1 week prior to CAR T-cell infusion.Corticosteroids: The washout period is 5 days prior to CAR T-cell infusion.
A negative urine pregnancy test is required within 1 week for all women ofchildbearing potential prior to enrolling on this trial.
For females of reproductive potential: use of highly effective contraception for atleast 1 month prior to screening and agreement to use such a method during studyparticipation and for an additional 4 months after infusion of siltuximab.
For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner
Willing and able to participate in all required evaluations and procedures in thisstudy protocol including receiving intravenous administration of the investigationalproduct and being admitted, when required, for at least 24 hours duringinvestigational product administration.
Exclusion
Exclusion Criteria:
Subjects requiring ongoing daily corticosteroid therapy at a dose of > 10 mg ofprednisone per day (or equivalent). Pulsed corticosteroid use for disease control isacceptable.
Active autoimmune disease requiring immunosuppressive therapy is excluded unlessdiscussed with the principal investigator (PI)
Pregnant women are excluded from this study.
Evidence of ongoing systemic bacterial, or fungal or viral infection, exceptlocalized fungal infection of skin or nails.
Patients with ongoing or past HIV infection.
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesActive - Recruiting
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