Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)

Not Applicable

Recruiting

• Conditions: Relapsed Cancer; Refractory Lymphoma; Diffuse Large B Cell Lymphoma; Lymphoma, B-Cell; Mediastinal Large B-cell Lymphoma; High-grade B-cell Lymphoma; Follicular Lymphoma; Mantle Cell Lymphoma
• Interventions: Radiation: Adaptive Bridging Radiation Therapy (ABRT)

• Registration Number: NCT06004167
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Participants are invited to take part in this research study because they have relapsed (cancer has come back) or refractory (cancer has not responded to treatment) B-cell Lymphoma and will be undergoing CAR T-cell Therapy.

This research is being done to see if a new radiation therapy administration schedule will positively impact the logistics, time, cost, and side effects of radiation therapy.

In this research study, participants will receive radiation therapy once weekly for 5 weeks. This is a novel administration schedule and we're looking to see how this schedule impacts side effects participants may experience, the time spent receiving radiation therapy, how much radiation therapy participants can receive, and how effective this new schedule is.

Detailed Description

This is a feasibility/pilot study of 5 Gy adaptive radiation administered every 5 business days (1 week apart) for 5 weeks prior to standard of care CAR T-cell therapy infusion. Approximately 10 participants with Relapsed/Refractory B-cell Lymphoma will take part in this research study. The primary objective is to assess the feasibility of once weekly radiation therapy for 5 weeks.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-22
• Study Start: 2024-01-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-07-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosis of relapsed or refractory B-cell lymphoma (including, but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, DLBCL arising from follicular lymphoma, follicular, and mantle cell lymphoma)
• Being planned to undergo CAR T-cell therapy (patients can be enrolled prior to apheresis)
• At least 1 measurable lesion according to the Lugano criteria35. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. Re-irradiation is allowed for these patients. More than 1 lesion can be targeted as per radiation oncologist discretion. If disease is palpable, physical examination alone may be sufficient measurement for disease if a recent PET/CT or CT is not available as a radiologic measurement of the disease can be obtained during CT simulation.
• Age ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 3.
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Any medical condition likely to interfere with assessment of safety or efficacy of RT.
• CNS-only disease as the site for bridging radiation therapy (which cannot be reliably evaluated on CT). Patients with CNS disease with extra-axial involvement that can be evaluated on CT remain eligible.
• Patient likely unable to lay supine for 45 minutes
• Women of child-bearing potential who are pregnant because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential
• In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5-5-5 Adaptive Bridging Radiation Therapy (ABRT)	Adaptive Bridging Radiation Therapy (ABRT)	5 Gy of adaptive radiation delivered every 5 business days (1 week apart) for up to 5 weeks prior to CAR T-cell therapy infusion

Primary Outcome Measures

Name	Time	Method
Feasibility: Percent of patients able to undergo ABRT	20 months	Feasibility is being measured based on the percentage of patients being able to undergo ABRT

Secondary Outcome Measures

Name	Time	Method
Adverse Events	20 months	Adverse events will be classified and graded according to the CTCAE v.5.0.
Objective Response Rate (ORR)	15 months	ORR is being measured using the day 30 and day 90 PET scans and assessed by Lugano lymphoma response criteria

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States