Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Not Yet Recruiting NCT05621096

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

Conditions: DLBCL - Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma, Mediastinal Large B-cell Lymphoma, Indolent B-Cell Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma

Sex: All
Ages: 19 Years – N/A
Phase: PHASE1
Enrollment: 33
Sponsor: University of Nebraska

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 cancerIf it is safe to give people radiation treatment before they receive a CAR T-cell treatment for their cancer

Eligibility Criteria

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 infusionPresence of disease on imaging including at least one disease site safe for radiation as determined by treating radiation oncologistWillingness to participate in clinical trial and provide informed consentAdequate 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 institutionEastern Cooperative Oncology Group (ECOG) performance status of 0-2Age 19 years or older, there is no upper limit to the ageExclusion Criteria:Subject is unsafe for radiation therapy as determined by investigator and/or radiation oncologistDiagnosis is primary central nervous system (CNS) lymphoma (secondary CNS lymphoma with additional systemic site is allowed)Requirement for concurrent high dose methotrexateSecondary 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.Pregnant or nursing womenUncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as determined by investigatorUnwillingness to follow procedures required in the protocolInadequate organ or hematologic conditions that prohibit the use of lymphodepleting chemotherapyUse of lymphoma-directed therapy within 14 days of T-cell pheresis

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05621096). StuddyBuddy aggregates publicly available trial information.