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Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Sponsor: St. Jude Children's Research Hospital
Summary
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.
Official title: SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
128
Start Date
2025-01-23
Completion Date
2034-05
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
Dexamethasone
Given orally (PO) or intravenously (IV).
Vincristine
Given IV.
Inotuzumab
Given IV.
Blinatumomab
Given IV.
Dasatinib
Given PO.
IT MHA
Given Intrathecal (IT), Age adjusted.
Cyclophosphamide
Given IV.
Cytarabine
Given IV or IT.
Methotrexate
Given IT, IV, PO or intramuscular (IM).
6-Mercaptopurine
Given PO.
Calaspargase
Given IV.
Daunorubicin
Given IV.
Thioguanine
Given PO (participants intolerant to mercaptopurine).
Locations (2)
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States