Phase 2, Single-Arm Trial of Comprehensive Ablative Bridging Irradiation (CABI) Prior to CD19 CAR-T Cell Therapy in High-Risk, Relapsed or Refractory Large B Cell Lymphoma in Patients With Bulky Disease
H. Lee Moffitt Cancer Center and Research Institute
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- RadiationComprehensive Ablative Bridging Irradiation (CABI)
Participants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.
- BiologicalChimeric Antigen Receptor T-Cell Therapy
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.
Location
- Moffitt Cancer CenterTampa, Florida