St. Jude Children's Research Hospital
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective * To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives * To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17. * To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17. * To assess the event free and overall survival of patients treated with this therapy.
This study utilizes a single arm phase II design. Treatment will consist of 3 main phases: Induction, early post induction \[including Consolidation, Blinatumomab 1, High-Dose Methotrexate, Reinduction, Interim, Reconsolidation, and Blinatumomab 2\], and Maintenance. Induction: * Induction includes 7 days of therapy on the INITIALL classification protocol (NCT06289673) as well as 5 further weeks of treatment on this trial. Treatment includes 15 days of oral (PO) or intravenous (IV) dexamethasone, 3 weekly doses of vincristine IV, and 2 doses of inotuzumab IV on Days 2 and 8. Patients will th…
Inclusion Criteria: * Enrollment on INITIALL. * Age 1-18.99 years at the time of enrollment on INITIALL. * B-Acute lymphoblastic leukemia or lymphoblastic lymphoma. * No prior chemotherapy excluding therapy given on or allowed by INITIALL. * NCI high-risk (age 10 years or greater or presenting WBC count ≥50,000 cells/microL) or NCI standard-risk and a HR clinical feature as listed below: * CNS3 disease (≥5 WBC/microL CSF with blasts present) * Testicular involvement of leukemia * Steroid pretreatment defined as \>24 hours of therapy in the 14 days prior to enrollment on INITIALL if a p…
Given orally (PO) or intravenously (IV).
Given IV.
Given IV.
Given IV.
Given PO.
Given Intrathecal (IT), Age adjusted.
Given IV.
Given IV or IT.
Given IT, IV, PO or intramuscular (IM).
Given PO.
Given IV.
Given IV.
Given PO (participants intolerant to mercaptopurine).