Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
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.
Timeline
- Start
- 2025-01-23
- Primary completion
- 2028-05
- Completion
- 2034-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | Intravenous |
| Subject | Inotuzumab | Other / unclassified | — | Intravenous |
| Background | Calaspargase | Unknown | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Thioguanine | Small molecule | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | dasatinib anhydrous | Small molecule | — | Oral |