Comparing once vs. twice daily radiation therapy for lymphoma treatment
Hyperfractionated Dual Equivalent Fractionated (HyDEF) Bridging Radiation Therapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Undergoing T-Cell Redirection Therapy
This study is testing whether giving radiation therapy once or twice a day can help people with relapsed lymphoma feel better and respond to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | CAR T, radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06898905 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of a novel method for comparing the effectiveness of hypofractionated versus hyperfractionated radiation therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) undergoing T-cell redirection therapies. It aims to treat the same tumor with two different radiation schedules to assess their relative effectiveness. The trial will also include correlative studies to understand the immune environment's response to the treatments. Additionally, PET imaging data will be collected to support the emerging method of administering bridging radiation in lymphoma.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with histologically confirmed R/R DLBCL and a tumor size of 5 cm or greater, who are planning to undergo CAR T or bispecific antibody therapy.
Not a fit: Patients who do not have relapsed/refractory diffuse large B-cell lymphoma or those unable to comply with the twice daily treatment schedule may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing radiation therapy schedules, potentially improving treatment outcomes for patients with R/R DLBCL.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing radiation therapy, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Adult aged 18 years or older. 4. Histologically confirmed diagnosis of R/R DLBCL with tumor size greater than or equal to 5 cm in its greatest dimension with plan for CAR T or BsAb therapy at Yale New Haven Hospital. 5. ECOG performance status 0 to 3. 6. Ability to present for twice daily (M-F) fractionated radiation therapy, without contraindications for radiotherapy as determined by the treating radiation oncologist. 7. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Participants must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed. Exclusion Criteria: Participants who meet any of the following criteria will be disqualified from entering the study: 1. Participants who are pregnant or currently breastfeeding. a. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential. 2. 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. 3. Participants who are unable to safely receive FDG PET tracer. 4. 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. 5. Participants who would not be anticipated to derive any clinical benefit from bridging radiotherapy, are unable to participate in twice daily radiotherapy, or have clinical contraindications to radiation therapy per treating investigator.
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Timothy J Robinson, MD PhD — Yale University
- Study coordinator: Stephanie Ladd
- Email: ycciprojectmanagement@yale.edu
- Phone: 203-785-5702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.