NCT06104592 Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL
| NCT ID | NCT06104592 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute |
| Condition | Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2023-11-08 |
| Primary Completion | 2026-12 |
Trial Parameters
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Brief 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 Criteria
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 assessment. * Ability to undergo comprehensive bridging radiation, defined as radiation to all visible sites of disease. * No evidence or suspicion of active central nervous system (CNS) involvement of lymphoma * Adequate bone marrow and organ function as defined in protocol. The effects of therapeutic agents used in this trial on developing human fetus are unknown, and because of this, women of child-be