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RECRUITING

NCT06898905

Hyperfractionated Dual Equivalent Fractionated Radiation Therapy

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

This study evaluates the feasibility and safety of 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).

Official title: Hyperfractionated Dual Equivalent Fractionated (HyDEF) Bridging Radiation Therapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Undergoing T-Cell Redirection Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-10-30

Completion Date

2027-04

Last Updated

2025-11-04

Healthy Volunteers

Conditions

Diffuse Large B-Cell Lymphoma

Interventions

OTHER

Bridging Radiation Therapy

Study 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.

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.

Locations (1)

Yale University

New Haven, Connecticut, United States