Adaptive Bridging RT in R/R B-cell Lymphoma (Pre-CAR T)
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.
Conditions:
🦠 Lymphoma, B-Cell 🦠 Relapsed Cancer 🦠 Refractory Lymphoma 🦠 Diffuse Large B Cell Lymphoma 🦠 Mediastinal Large B-cell Lymphoma 🦠 High-grade B-cell Lymphoma 🦠 Follicular Lymphoma 🦠 Mantle Cell Lymphoma
🗓️ Study Start (Actual) 14 January 2024
🗓️ Primary Completion (Estimated) 1 July 2024
✅ Study Completion (Estimated) 1 September 2024
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 August 2023
  • First Submitted that Met QC Criteria 16 August 2023
  • First Posted 22 August 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 April 2024
  • Last Update Posted 16 April 2024
  • Last Verified April 2024