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This study is evaluating the safety and efficacy of using radiotherapy in participants who have refractory lymphoma shortly after receiving CAR T cell therapy (axicel or tisacel).
Full description
This research study is a Pilot Study, which is the first time investigators are examining this intervention after administration of CAR T cell therapy. This research study looks to systematically investigate the safety and efficacy of radiotherapy following CAR T cell therapy (axicel or tisacel) in refractory lymphoma. CAR T cell therapy involves genetically modifying T cells to target tumor cells for death. Radiotherapy is a standard treatment offered with refractory lymphoma and uses high-energy x rays, or particles, to destroy or damage cancer cells. Few have received CAR T cell therapy prior to radiation therapy and this study aims to gather more information on radiotherapy following CAR T cell therapy as a treatment option and its potential to improve participants immune system's response to cancer cells as well as its interaction with CAR T cell therapy to better treat refractory lymphoma.
The research study procedures include screening for eligibility, enrollment, biopsy following radiation, post-treatment period, and long-term follow-up.
Participants will receive radiotherapy at a dose and schedule determined by the study doctor. Participants will be followed for up to 24 months after completion of study treatment.
It is expected that about 20 people will take part in this research study.
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Inclusion criteria
Patients must be able to undergo biopsy. Biopsy will be obtained for patients to exclude possibility of false negative residual FDG avidity on PET/CT that is not substantially increased relative to pre-CAR-T PET/CT. Exceptions are allowed for patients who have clearly progressive disease for whom delaying radiation therapy to obtain a biopsy may worsen outcome (such as cases of cord compression), and for patients for whom the risks of biopsy are high (such as patients with evidence for CNS involvement).
Biopsy-confirmed refractory disease within 30-90 days following commercial axicabtagene ciloleucel or tisagenlecleucel therapy for a hematologic malignancy (these include relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma). Of note, 'refractory' refers to patients who had early refractory disease after CAR-T cell therapy and not to patients who have received CAR-T for refractory disease, but had complete response to CAR-T cell therapy.
At least 1 measurable lesion according to the Lugano criteria1. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy
The following criteria pertain to pattern of progression:
Patients may have one refractory lesion without other residual or progressive disease as per PET/CT
Patients may have more than one refractory lesion, but with evidence for at least partial response of at least one other lesion as per PET/CT
Patients with more than one site of refractory disease without evidence for at least partial response of at least one other lesion are eligible if they are:
Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia and prolonged cytopenias that are not expected to worsen during RT) if there is concern for overlap of anticipated radiation-related toxicity and toxicity from prior therapy due to where the RT field is located.
Age 18 or older
Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
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Central trial contact
Chirayu G Patel, MD, MPH
Data sourced from clinicaltrials.gov
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