Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
- Conditions
- Diffuse Large B Cell Lymphoma
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria:<br><br> - Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma<br> (DLBCL) who plan to receive treatment at the Moffitt Cancer Center/<br><br> - Adult males or females who are 18 years of age or older at time of signing informed<br> consent.<br><br> - Must have ability to comprehend and the willingness to sign written informed consent<br> for study participation.<br><br> - Eligible to receive CAR-T cell therapy (axicabtagene ciloleucel) for DLBCL and<br> histological variants.<br><br> - Patients must have a serum ferritin level above 400 mg/mL and C-reactive protein<br> level above 2 mg/dL (20 mg/L) at screening.<br><br> - ECOG performance status 0 to 2.<br><br> - The effects of Itacitinib on the developing human fetus are unknown. For this reason<br> and because Janus kinase (JAK)1-selective inhibitors as well as other therapeutic<br> agents used in this trial are known to be teratogenic, women of child-bearing<br> potential and men must agree to use adequate contraception (hormonal or barrier<br> method of birth control; abstinence) prior to study entry and for the duration of<br> study participation as outlined in criteria below: (a) Men must agree to take<br> appropriate precautions to avoid fathering children (with at least 99% certainty)<br> from screening through safety follow up and must refrain from donating sperm during<br> this period. Permitted methods that are at least 99% effective in preventing<br> pregnancy should be communicated to the participants in their understanding<br> confirmed.(b) Women of childbearing potential must have a negative serum pregnancy<br> test at screening and before the first dose of Day 1 and must agree to take<br> appropriate precautions to avoid pregnancy (with at least 99% certainty) from<br> screening through safety follow up. Permitted methods that are at least 99%<br> effective in preventing pregnancy should be communicated to the participants and<br> their understanding confirmed. (c) Women of non-childbearing potential (ie,<br> surgically sterile with a hysterectomy and/or bilateral oophorectomy OR >= 12 months<br> of amenorrhea) are eligible.<br><br> - Patients must be ineligible for stem cell transplant at screening on the basis of<br> active lymphoma.<br><br> - Patients must meet laboratory parameters at screening as defined in protocol<br><br>Exclusion Criteria:<br><br> - Patients who are currently receiving or who have received any investigational study<br> agent =4 weeks prior to screening visit are ineligible.<br><br> - Prior treatment with chimeric antigen receptor (CAR) T-cell therapy.<br><br> - Participants with clinically significant or uncontrolled cardiac disease, including<br> unstable angina, acute myocardial infarction within 6 months from screening, New<br> York Health Association III or IV heart failure, and circulatory collapse requiring<br> vasopressor or inotropic support<br><br> - Participants with arrhythmias that are not stable on a medical management program<br> within 2 weeks of screening are also excluded.<br><br> - Participants with arrhythmias that are not stable on a medical management program<br> within 2 weeks of screening are also excluded.<br><br> - Evidence of active uncontrolled/untreated infection (viral, bacterial, fungal,<br> opportunistic) of any origin.<br><br> - Participants with a known history or prior diagnosis of immunologic or<br> inflammatory/autoimmune disease affecting the CNS, and unrelated to their disease<br> under study or previous treatment.<br><br> - Known positive Human immunodeficiency virus (HIV) status.<br><br> - Participants with evidence of active and/or chronic hepatitis B virus (HBV)<br> infection, HBV viral load must be undetectable on suppressive therapy, if indicated.<br><br> - Participants with a history of hepatitis C virus (HCV) infection, HCV must have been<br> treated and cured.<br><br> - Participants who require the concurrent use of chronic systemic steroids or<br> immunosuppressant medications. Steroids should not be given within 5 days prior to<br> leukapheresis. Concomitant bridging steroids (section 6.6) are allowed after<br> leukapheresis.<br><br> - Known hypersensitivity or severe reaction to itacitinib, similar compounds, or<br> excipients or itacitinib.<br><br> - Participants who have not recovered from adverse events (AEs) due to prior<br> anti-cancer therapy (i.e., have residual toxicities > Grade 1), with the exception<br> of stable Grade 2 peripheral neuropathy and/or any grade alopecia.<br><br> - Pregnant or nursing (breast-feeding) women are excluded from this study because<br> there is an unknown but potential risk to using itacitinib in pregnant or nursing<br> women.<br><br> - Any condition that would, in the investigator's judgement, interfere with full<br> participation in the study, including administration of itacitinib and attending<br> required study visits (if outpatient); pose a significant risk to the participant;<br> or interfere with interpretation of study data.<br><br> - Inability of the participant to swallow and retain oral medication.<br><br> - Participants receiving any medications or substances that are strong inhibitors of<br> CYP3A4 are ineligible. As part of the enrollment/informed consent procedures, the<br> participant will be counseled on the risk of interactions with other agents and what<br> to do if new medications need to be prescribed or if the participant is considering<br> a new over-the-counter medicine or herbal product.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS)
- Secondary Outcome Measures
Name Time Method Incidence of Severe Cytokine Release Syndrome (CRS);Incidence of Severe Immune efflector cell Associated Neurotoxicity Syndrome (ICANS);Overall Response Rate;Overall Survival (OS);Progression Free Survival (PFS)