Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma (NCT05621096) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma
United States33 participantsStarted 2023-03-21
Plain-language summary
The goal of this clinical trial is to learn about treatment for people with B-cell lymphoma that did not respond to treatment or that has gotten worse after treatment. The aim of this trial is to answer the following questions:
* If it is realistic to give people radiation treatment before they receive a chimeric antigen receptor (CAR) T-cell treatment for their cancer
* If it is safe to give people radiation treatment before they receive a CAR T-cell treatment for their cancer
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. Biopsy-proven relapsed or progressive diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, primary mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or DLBCL arising from indolent lymphoma meeting an FDA-approved (Food and Drug Administration-approved) indication for liso-cel infusion
✓. Presence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologist
✓. Willingness to participate in clinical trial and provide informed consent
✓. Adequate organ function as assessed by standard institution protocols and United States (US) prescribing information label for comorbidities, heart, and lung function to undergo FDA-approved CAR T-cell therapy as determined by institution
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
✓. Age 19 years or older, there is no upper limit to the age
Exclusion criteria
✕. Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologist
✕. Diagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed)
✕. Requirement for concurrent high dose methotrexate
✕. Secondary active malignancy that has not been in remission for at least 2 years. This excludes non-melanoma skin cancer, definitively treated stage 1 solid tumor with low risk or recurrence, and curatively treated localized prostate cancer.
What they're measuring
1
Feasibility of the intervention in the proposed study population
✕. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigator
✕. Unwillingness to follow procedures required in the protocol
✕. Inadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapy