Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (NCT05757219) | Clinical Trial Compass
RecruitingPhase 2
Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy
United States27 participantsStarted 2023-05-19
Plain-language summary
The purpose of the study is to assess the safety and efficacy of once daily itacitinib oral administration in participants with diffuse large B-cell lymphoma (DLBCL) who will receive CAR-T cell therapy with axicabtagene ciloleucel (axi-cel).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients with a histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) who plan to receive treatment at the Moffitt Cancer Center/
* Adult males or females who are 18 years of age or older at time of signing informed consent.
* Must have ability to comprehend and the willingness to sign written informed consent for study participation.
* Eligible to receive CAR-T cell therapy (axicabtagene ciloleucel) for DLBCL and histological variants.
* Patients must have a serum ferritin level above 400 mg/mL and C-reactive protein level above 2 mg/dL (20 mg/L) at screening.
* ECOG performance status 0 to 2.
* The effects of Itacitinib on the developing human fetus are unknown. For this reason and because Janus kinase (JAK)1-selective inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation as outlined in criteria below: (a) Men must agree to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow up and must refrain from donating sperm during this period. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants in their understanding confirmed.(b) Women of childbearing potential m…
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: at 6 months
Trial details
NCT IDNCT05757219
SponsorH. Lee Moffitt Cancer Center and Research Institute