Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

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.

NCT Number	NCT06533748
Lead Sponsor	St. Jude Children's Research Hospital Collaborators: Pfizer, Amgen
Conditions	Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Enrollment	128 participants
Start Date	2025-01-23
Primary Completion	2028-05 (estimated)
Study Completion	2034-05 (estimated)
Updated on ClinicalTrials.gov	2026-07-16