Bridging Radiation Therapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This study is looking at a new way to give radiation therapy to people with diffuse large B-cell lymphoma (DLBCL) that has come back or not responded to previous treatment (relapsed/refractory or R/R DLBCL). It's for patients who are planning to receive CAR T-cell therapy or bispecific antibodies (BsAb), which are treatments that help your immune system fight cancer. The study will compare two ways of giving radiation – once a day (hypofractionated) versus twice a day (hyperfractionated) – to different parts of the same tumor. The main goals are to see if this type of radiation is possible to give and safe, and to track changes in circulating tumor DNA (ctDNA) to understand how well the treatment is working. You can join if you are 18 or older with R/R DLBCL and are planning for CAR T or BsAb therapy at Yale New Haven Hospital. This study is currently recruiting about 10 participants.
- Study design
- This is an interventional study with a planned enrollment of 10 participants. Each participant will serve as their own control, with different parts of their tumor receiving different radiation schedules.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be monitored throughout the study, for approximately two years. Feasibility will be assessed at approximately one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hyperfractionated Dual Equivalent Fractionated Radiation Therapy
At a glance
Conditions
NCT06898905
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Yale University
New Haven, Connecticutstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Timothy J Robinson, MD PhD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Feasibility Assessment of Bridging Radiation TherapyApproximately one year
Feasibility will be assessed by the proportion of enrolled participants who are successfully treated according to the proposed bridging radiation therapy schema.
- Safety analysis of Bridging Radiation TherapyThroughout the study, approximately two years
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.
- Dynamics of Circulating Tumor DNA (ctDNA) as a Marker of Minimal Residual DiseaseBaseline (0-7 days prior to radiation therapy) to post-radiation therapy (prior to initiation of lymphodepleting chemotherapy)
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.
- Biomarkers of Hypoxia and Immune Exhaustion in Relation to Treatment ResponseBaseline (0-7 days prior to radiation therapy) to post-radiation therapy (prior to initiation of lymphodepleting chemotherapy).
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.