Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
Summary
This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Primary Objective * To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231. * To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231. Secondary Objectives * To assess the event free and overall survival of patients treated with this therapy. * To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.
Timeline
- Start
- 2024-12-27
- Primary completion
- 2027-12
- Completion
- 2033-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | — | Intravenous |
| Subject | Venetoclax | Small molecule | — | Oral |
| Subject | dasatinib anhydrous | Small molecule | — | Oral |
| Background | Calaspargase Pegol | Protein / enzyme biologic | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Cytarabine | Small molecule | — | Intravenous |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intrathecal |
| Background | Nelarabine | Small molecule | — | Intravenous |
| Background | Thioguanine | Small molecule | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |