Hyperfractionated Dual Equivalent Fractionated Radiation Therapy

NCT06898905 | Recruiting DMC

• 2 other identifiers: 2000038092IRG-21-132-60-IRG
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

HyDEF; bridging radiation; once vs twice daily radiation

Outcome Measures

Primary Outcomes (2)

• Feasibility Assessment of Dual Fractionated Radiation Therapy Enrollment and Treatment

  The feasibility of the clinical trial's intervention will be assessed based on the ability to enroll and treat at least 5 participants with the proposed dual fractionated radiation therapy, where one half of the tumor receives once daily radiation and the other half receives twice daily radiation. This number is estimated to be sufficient to determine the feasibility of treating a single tumor with different radiation schedules.

  Approximately one year

• Safety analysis of the proposed dual fractionated radiation therapy schema

  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.

  Throughout the study, approximately two years

Study Arms (1)

Dual Hyperfractionated Radiation Therapy

EXPERIMENTAL

All patients enrolled will receive radiation as a bridge to subsequent planned T Cell Directed therapy. The same tumor will be treated daily, with one area receiving once daily and the other receiving twice daily radiation therapy.

Other: Bridging Radiation Therapy

Interventions

Bridging Radiation Therapy OTHER

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.

Dual Hyperfractionated Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• ECOG performance status 0 to 3.
• Ability to present for twice daily (M-F) fractionated radiation therapy, without contraindications for radiotherapy as determined by the treating radiation oncologist.
• 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.

You may not qualify if:

• Participants who meet any of the following criteria will be disqualified from entering the study:
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Timothy J Robinson, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Ladd

CONTACT

203-785-5702; ycciprojectmanagement@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 27, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)