Pediatric-Inspired Chemotherapy Plus Tyrosine Kinase Inhibitor in Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Summary
This study will combine a standard, pediatric-inspired, chemotherapy regimen with the tyrosine kinase inhibitors (TKIs) Dasatinib and Ponatinib to treat adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. There are two age groups/cohorts: * participants aged 18 to 59 years * participants aged 60 years and older One tyrosine kinase inhibitor (TKI), either Dasatinib or Ponatinib, will be administered in each of the respective chemotherapy cycles. The TKI (either Dasatinib or Ponatinib) administered in a given cycle of chemotherapy will be dictated by the given cycle's standard chemotherapy, in order to minimize overlapping side effects of the chemotherapy and TKI. The dosages of the standard chemotherapy agents, as well as the tyrosine kinase inhibitors (TKIs)--Dasatinib and Ponatinib--have been adjusted for each age group to allow continuous administration of these TKIs.
Timeline
- Start
- 2024-01
- Primary completion
- 2026-01
- Completion
- 2029-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Cytarabine | Small molecule | — | Intrathecal |
| Subject | Daunorubicin | Small molecule | — | — |
| Subject | Dexamethasone | Small molecule | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Subject | Methotrexate | Small molecule | — | Intrathecal |
| Subject | Pegaspargase | Protein / enzyme biologic | — | — |
| Subject | Ponatinib | Small molecule | — | Oral |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | — | — |
| Subject | Thioguanine | Small molecule | — | — |
| Subject | Vincristine | Small molecule | — | — |
| Subject | dasatinib anhydrous | Small molecule | — | Oral |