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

Description

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

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

Study Overview

Study Details

Study overview

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

Feasibility of Low Dose Radiation as Bridging Therapy for Lisocabtagene Maraleucel in Relapsed B-Cell Non-Hodgkin Lymphoma

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

Condition
DLBCL - Diffuse Large B Cell Lymphoma
Intervention / Treatment

-

Contacts and Locations

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Nebraska,

Christopher R D'Angelo, MD, PRINCIPAL_INVESTIGATOR, University of Nebraska

Study Record Dates

2025-07