About this trial
The proposed research will compare the effects of TBI prior to CAR T cell infusion to the current standard of care using lymphodepletion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 Platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN
Disqualifiers
Patients who are receiving any other investigational agents.
Patients who need craniospinal irradiation for CNS leukemia prior to CAR T cell therapy.
Patients with uncontrolled intercurrent illness (Indicate clearly what type or extent)
Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Trial design
Single group
Treatments tested in this trial
CAR T cell therapy
DrugCAR T cell therapy will be administered as per the institutional guidelines and as per our standard of care
Treatment groups
Trial outcomes
Primary outcomes
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: