Clinical Research Directory

Inclusion Criteria: * From 18 to 60 years old * Signed informed consent prior to participation in the study * Diagnosis of relapsed or refractory B-cell ALL after at least two lines of treatment * Documented CD19 positivity either by immunohistochemistry analysis or flow cytometry in the last available evaluation * ECOG performance status ≤2 * Women of childbearing potential must have a negative serum pregnancy test * Adequate renal, hepatic, pulmonary, and cardiac function * Bone marrow function specifications at least 48 hours prior to recruitment: hemoglobin ≥8 g/dL, absolute neutrophil count (ANC) ≥500/µL, absolute lymphocyte count ≥300/µL, platelet count ≥30,000/µL Exclusion Criteria: * Recipient of CAR-T cell therapy outside this protocol * Active involvement of the central nervous system or meninges by any neoplasm (patients with a history of CNS or meningeal involvement must be in documented remission by CSF evaluation for at least 90 days before registration) * History of active malignant neoplasm other than the underlying B-cell ALL, excluding non-melanoma skin cancer * Active or ongoing infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illnesses/social situations that would limit compliance with the study requirements * Pregnant or breastfeeding women * Evidence of myelodysplasia in bone marrow aspirate before the start of treatment * Active infection by human immunodeficiency virus (HIV) * Serologic status that reflects active infection by hepatitis B or C * History of COVID-19 infection in the last 3 months * Grade 1 or higher adverse events associated with SARS-CoV-2, with the exception of peripheral neuropathy