New radiation therapy schedule for relapsed B-cell lymphoma before CAR T-cell therapy
5-5-5 Adaptive Bridging Radiation Therapy (ABRT) for Relapsed/Refractory B-cell Lymphoma Prior to CAR T-cell Therapy
This study is testing a new weekly radiation treatment for people with relapsed B-cell lymphoma to see if it helps them do better before they receive CAR T-cell therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | CAR T, chemotherapy, radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT06004167 on ClinicalTrials.gov |
What this trial studies
This research involves participants with relapsed or refractory B-cell lymphoma who are scheduled to undergo CAR T-cell therapy. The study aims to evaluate a novel radiation therapy schedule, administering radiation once weekly for five weeks, to assess its feasibility and impact on side effects, treatment logistics, and overall effectiveness. Approximately 10 participants will be enrolled to determine how this new approach compares to traditional radiation therapy schedules. The primary goal is to see if this adaptive bridging radiation therapy can improve patient outcomes before CAR T-cell infusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of relapsed or refractory B-cell lymphoma who are planning to undergo CAR T-cell therapy.
Not a fit: Patients with non-relapsed or non-refractory B-cell lymphoma or those not eligible for CAR T-cell therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more effective and manageable radiation therapy regimen for patients with relapsed B-cell lymphoma.
How similar studies have performed: While this specific approach is novel, similar studies exploring adaptive radiation therapy have shown promising results in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Chirayu Patel, MD — Massachusetts General Hospital
- Study coordinator: Chirayu Patel, MD
- Email: cpatel@mgh.harvard.edu
- Phone: (617) 724-2430
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.