M.D. Anderson Cancer Center
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.
Primary Objective: To understand how 2 Gy TBI administered before CAR T cell infusion changes the immune system compared to a control group with no TBI, with the potential to improve the infused cell engraftment, efficacy, and sustainability. The primary endpoint is CAR T-cell level. Compare both groups by looking at the CAR T cell levels at standard of care time points 1, 4, 8, 11, 14, 21, and 28, and then every 3 months for a total of a year Secondary Objectives: Preliminarily estimate the effects of TBI on circulating inflammatory and immunosuppressive cytokines in the blood. The working…
Inclusion Criteria: * Patients must have a confirmed diagnosis of Acute Lymphoblastic Lymphoma and are planned to undergo CAT T cell therapy. The patient should not be planned to receive craniospinal irradiation prior to CAR T therapy; the latter group will be excluded from this study. Prior Radiation would not exclude patients from getting 2 Gy TBI, including prior TBI, in the event of a prior stem cell transplant. * Age ≥18 years. * ECOG performance status ≤2 (Karnofsky ≥60%,). * Patients must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL Pla…
CAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care
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