Hyperfractionated Dual Equivalent Fractionated Radiation Therapy
ConditionDiffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About this trial
This study evaluates the feasibility and safety of bridging radiation therapy, including a novel method for comparing the effectiveness of hypofractionated versus hyperfractionated radiation therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) undergoing T-cell redirection therapies (CAR T-cell therapy or bispecific antibodies).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Adult aged 18 years or older.
Histologically confirmed diagnosis of R/R DLBCL with plan for CAR T or BsAb therapy at Yale New Haven Hospital.
Disqualifiers
Participants who are pregnant or currently breastfeeding.
Participants with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure.
Participants who are unable to safely receive FDG PET tracer.
Any condition that would, in the investigator's judgment, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.
Trial design
Design model
Single group
Treatments tested in this trial
Bridging Radiation Therapy
Other interventionStudy seeks to compare the hypofractionated radiation therapy with hyperfractionated treatment within the same tumor. Each participant will be serving as their own control; half their tumor will receive once daily hypofractionated (QD) bridging radiotherapy, and the other half of their tumor will receive twice daily hyperfractionated (BID) bridging radiotherapy. Either schedule is considered standard of care and this study aims to determine which schedule may prove superior between the two standards.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Dual Hyperfractionated Radiation TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility Assessment of Bridging Radiation Therapy
Feasibility will be assessed by the proportion of enrolled participants who are successfully treated according to the proposed bridging radiation therapy schema.
Time frame
Approximately one year2
Safety analysis of Bridging Radiation Therapy
Safety will be assessed by analyzing the incidence of severe (grade ≥ 3) acute toxicities. The therapy will be considered safe if fewer than 30% of study participants receiving dual fractionated radiation therapy experience these toxicities.
Time frame
Throughout the study, approximately two years3
Dynamics of Circulating Tumor DNA (ctDNA) as a Marker of Minimal Residual Disease
Changes in serum ctDNA levels will be measured at baseline and after radiation therapy (RT) to characterize ctDNA dynamics and assess minimal residual disease. Comparisons will focus on quantitative shifts in ctDNA burden in relation to treatment response.
Time frame
Baseline (0-7 days prior to radiation therapy) to post-radiation therapy (prior to initiation of lymphodepleting chemotherapy)4
Biomarkers of Hypoxia and Immune Exhaustion in Relation to Treatment Response
Serum biomarkers associated with tumor hypoxia and immune exhaustion will be evaluated at baseline and after radiation therapy (RT). Changes in these biomarkers will be compared to characterize biological responses to treatment and their relationship to clinical outcomes.
Time frame
Baseline (0-7 days prior to radiation therapy) to post-radiation therapy (prior to initiation of lymphodepleting chemotherapy).Sponsors and contacts
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Yale University
Lead sponsor
American Cancer Society, Inc.
Collaborator
Source ClinicalTrials.gov