Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma

Launched by UNIVERSITY OF NEBRASKA · Nov 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of low-dose radiation therapy as a potential treatment for patients with certain types of B-cell lymphoma that have either not responded to previous treatments or have worsened. Specifically, the trial aims to find out if it's safe and feasible to give radiation before patients receive a special treatment called CAR T-cell therapy, which uses the body’s immune cells to fight cancer. The trial is currently recruiting participants aged 19 and older who have confirmed cases of specific B-cell lymphomas and can safely receive radiation therapy.

To be eligible, participants must have a confirmed diagnosis of relapsed or progressive B-cell lymphoma and must have at least one area of disease that can be safely treated with radiation. They must also be willing to participate in the trial and meet certain health criteria to ensure they can undergo the CAR T-cell therapy afterward. If you join this trial, you can expect close monitoring by medical professionals to ensure your safety and health throughout the treatment process. It's important to note that certain conditions, like being pregnant or having uncontrolled medical issues, may prevent someone from participating.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. Presence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologist
• • 3. Willingness to participate in clinical trial and provide informed consent
• • 4. 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
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• • 6. Age 19 years or older, there is no upper limit to the age
• Exclusion Criteria:
• • 1. Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologist
• • 2. Diagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed)
• • 3. Requirement for concurrent high dose methotrexate
• • 4. 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.
• • 5. Pregnant or nursing women
• • 6. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigator
• • 7. Unwillingness to follow procedures required in the protocol
• • 8. Inadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapy
• • 9. Use of lymphoma-directed therapy within 14 days of T-cell pheresis