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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Comprehensive Ablative Bridging Irradiation (CABI)
RadiationParticipants will receive radiation therapy to all pretreatment lesions that are able to be feasibly and safely treated.
Chimeric Antigen Receptor T-Cell Therapy
Biological/VaccineYascarta 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.
Treatment groups
27 Participants
are divided into 1 treatment groupGroup A: Radiation Therapy and CAR T-Cell InfusionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS)
PFS will be measured by date of CAR T-cell infusion until first occurrence of in-field, local, or distant progression, or death. If none of these events occur, patients will be censored on date of last contact.
Time frame
at 12 monthsSecondary outcomes
1
Rate of local relapse (i.e., relapse of lymphoma at a body site that received bridging radiation therapy)
Rate of local relapse determined by evidence of disease at a body site that received bridging radiation therapy.
Time frame
up to 12 months2
Rate of distant relapse (i.e., relapse of lymphoma at a body site that did not receive bridging radiation therapy)
Rate of distant relapse determined by evidence of disease at a body site that did not receive bridging radiation therapy.
Time frame
up to 12 months3
Number of serious adverse events attributed to bridging radiotherapy
Number of serious adverse events that can be attributed to bridging radiotherapy
Time frame
Up to 12 months4
Number of serious adverse events attributed to CAR T-cell infusion
Number of serious adverse events that can be attributed to CAR T-cell infusion
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Kite, A Gilead Company
Collaborator
Source ClinicalTrials.gov