Evaluation of Bridging Radiation Therapy Before CAR T-Cell Infusion for the Treatment of Relapsed or Refractory Large B-Cell Lymphoma

Launched by CITY OF HOPE MEDICAL CENTER · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with a type of cancer called large B-cell lymphoma that has either come back after treatment or did not respond to earlier therapies. The study is testing whether giving patients radiation therapy before a special treatment called CAR T-cell therapy can improve their outcomes. CAR T-cell therapy involves taking some of the patient's own immune cells, modifying them in the lab to better fight the cancer, and then putting them back into the patient. The radiation therapy is meant to help control the cancer and manage any symptoms while waiting for the CAR T-cells to be ready.

To be eligible for this trial, participants need to be at least 18 years old, have been diagnosed with large B-cell lymphoma, and have had their cancer come back or not respond to other treatments. They should also plan to receive CAR T-cell therapy within three months of joining the study. Patients will undergo some tests to ensure they are healthy enough for the study. If they choose to participate, they can expect to receive both the radiation therapy and the CAR T-cell infusion, with the hope that this combined approach will lead to better results with fewer side effects. It’s important for potential participants to discuss their specific situation with their doctors to see if this trial is the right option for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented informed consent of the participant and/or legally authorized representative.
• • Assent, when appropriate, will be obtained per institutional guidelines.
• • Age: \>= 18 years.
• • Eastern Cooperative Oncology Group (ECOG) =\< 2 or Karnofsky Performance Status (KPS) \>= 60.
• • Histologically confirmed large B-cell lymphoma.
• • Relapsed/refractory disease.
• • Planned to undergo commercial CAR T-cell infusion within 3 months of enrollment.
• • 6 or fewer sites (treatable with a maximum of 3 isocenters) of FDG-PET avid disease, treatable with a a maximum of 3 isocenters.
• • Measurable disease e.g., at least 1.5 cm on CT/MRI or by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).
• • Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 to prior anti-cancer therapy.
• • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 30 days prior to day 1 of protocol therapy).
• • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Exclusion Criteria:
• • Prior CD19-directed therapy.
• • Radiation therapy within 21 days prior to day 1 of protocol therapy.
• • Central nervous system (CNS) disease.
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
• • Active diarrhea.
• • Clinically significant uncontrolled illness.
• • Active infection requiring antibiotics.
• • Other active malignancy.
• • Females only: Pregnant.
• • Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.
• • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).