SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
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.
Description
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…
Eligibility
- Age range
- 1–18 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugDexamethasone
Given orally (PO) or intravenously (IV).
- DrugVincristine
Given IV.
- DrugInotuzumab
Given IV.
- DrugBlinatumomab
Given IV.
- DrugDasatinib
Given PO.
- ProcedureIT MHA
Given Intrathecal (IT), Age adjusted.
- DrugCyclophosphamide
Given IV.
Locations (2)
- Saint Francis Children's HospitalTulsa, Oklahoma
- St. Jude Children's Research HospitalMemphis, Tennessee