Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
Trial Parameters
Brief Summary
This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
Eligibility Criteria
Inclusion Criteria: * Must be an adult 18 years of age or older. * Pathologically confirmed CD19 positive B-cell acute lymphoblastic leukemia. * Treatment and full recovery from induction chemotherapy, with following exceptions: A. Vincristine associated grade 1 peripheral neuropathy B. Steroid/asparaginase associated diabetes and/or hypertension C. Inotuzumab/chemotherapy associated cytopenias * Patients must be in a complete remission with Minimal Residual Disease (MRD) following an induction regimen. MRD is defined herein as a bone marrow biopsy with fewer than 5% lymphoblasts. Complete remission implies the resolution of any extramedullary and/or Central Nervous Syndrome (CNS)-2-3/parenchymal disease. * Be willing and able to provide written informed consent/assent for the trial. * Able to adhere to the study visit schedule and other protocol requirements. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Adequate renal, hepatic, pulmonary, cardiac function. * A