Single-Arm Comprehensive Ablative Bridging Irradiation I Prior to CD19 CAR-T In High-Risk R/R LBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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
Qualifiers
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.
Disqualifiers
Patients who are currently receiving or who have received any other investigational study agent ≤4 weeks prior to screening visit are ineligible
Prior treatment with chimeric antigen receptor (CAR) T-cell therapy
Inability to safely deliver comprehensive radiation therapy to all sites of disease per treating radiation oncologists' discretion
Participants with clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from screening, New York Health Association III or IV heart failure, and circulatory collapse requiring vasopressor or inotropic support.
Trial design
Treatments tested in this trial
- Comprehensive Ablative Bridging Irradiation (CABI)
- Chimeric Antigen Receptor T-Cell Therapy
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Kite, A Gilead Company
Collaborator
Source ClinicalTrials.gov