💬In plain words
What the trial is, and whether it could suit you
This early phase I clinical trial evaluates bridging radiation therapy given before chimeric antigen receptor (CAR) T-cell infusion to treat large B-cell lymphoma (LBCL) that has come back (relapsed) or has not responded to previous treatment (refractory). Patients with relapsed or refractory disease have historically poor prognosis. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood (leukapheresis). Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
💊
What it tests
- Biospecimen Collection
- Chimeric Antigen Receptor T-Cell Therapy
- Computed Tomography
- External Beam Radiation Therapy
- Leukapheresis
City of Hope Medical Center
Duarte, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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