Low Dose Radiation as Bridging Therapy in Relapsed B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT05621096
Last Updated: 2025-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE1
33 participants
INTERVENTIONAL
2023-03-21
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
NCT05574114
Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma
NCT05800405
Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)
NCT06004167
An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma
NCT05929716
A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas
NCT07029217
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Emerging cellular immunotherapies including CAR T-cell therapy have produced remarkable outcomes for this population. The Food and Drug Administration (FDA) has recently approved lisocabtagene maraleucel (liso-cel) for the management of people with relapsed and refractory B-cell lymphoma. Unfortunately, many patients undergoing liso-cel infusion will suffer progression or relapse with devastating consequences. The object of this study is to identify a novel means to enhance liso-cel activity to improve overall outcomes. The investigators hypothesize that the addition of radiation therapy targeting selected sites as bridging therapy prior to lymphodepleting chemotherapy and liso-cel infusion will be effective at improving responses for patients with relapsed and refractory B-cell lymphoma.
Results from this study will provide key justification to expand this therapeutic approach into a larger phase II clinical trial powered to examine the efficacy of this approach.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single arm
Subjects will receive 4 gray (Gy) radiation in 2 fractions in the bridging period following lymphocyte pheresis, prior to lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T-cell infusion. Post CAR T-cell infusion radiation therapy will be allowed as determined by study investigator but prespecified at time of radiation oncology consultation.
Bridging radiation therapy
Days -20 to -7: Patients will receive 2 fractions of 2 gray (Gy) for a total of 4 Gy received.
Liso-cel
Day 0: Patients will receive an infusion of liso-cel CAR T-cell product.
Prior to the liso-cell infusion (Days -5 to -3), patients will receive lymphodepleting chemotherapy using fludarabine 30mg/m2 and cyclophosphamide 300mg/m2 per institutional standard procedures.
Post-infusion radiation
Days 30 to 80: Patients eligible for post-infusion radiation will receive a total dose of up to 32 Gy.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bridging radiation therapy
Days -20 to -7: Patients will receive 2 fractions of 2 gray (Gy) for a total of 4 Gy received.
Liso-cel
Day 0: Patients will receive an infusion of liso-cel CAR T-cell product.
Prior to the liso-cell infusion (Days -5 to -3), patients will receive lymphodepleting chemotherapy using fludarabine 30mg/m2 and cyclophosphamide 300mg/m2 per institutional standard procedures.
Post-infusion radiation
Days 30 to 80: Patients eligible for post-infusion radiation will receive a total dose of up to 32 Gy.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
University of Nebraska
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Christopher R D'Angelo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Nebraska
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Nebraska Medical Center
Omaha, Nebraska, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0770-22-FB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.