H. Lee Moffitt Cancer Center and Research Institute
This is a phase 2, single-arm, open-label study to evaluate the safety and efficacy of comprehensive bridging radiation therapy prior to CD19 CAR T-cell therapy for large B-cell lymphoma patients with bulky disease, defined as any lesion ≥5 cm.
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 will be eligible. * 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 LBCL and histological variants approved by the standard of care label * ECOG performance status 0 to 2. * At least one high-risk lesion, defined as measuring ≥ 5 cm, that is targetable for radiotherapy per investigator assess…
Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.
Yascarta is an autologous anti-CD19 CAR T cell therapy manufactured from the patient's own T cells, which have been extracted and then reprogrammed with CAR molecules to help the T cells recognize cancer cells. The reengineered T cells are infused back into the patient to attack the cancer.
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