drugset / Trial / NCT04530565
Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
RandomizedCrossoverOpen-labelTreatment
Summary
This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.
Timeline
- Start
- 2021-01-25
- Primary completion
- 2028-07-01
- Completion
- 2028-07-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Ponatinib | Small molecule | 30 mg | Oral |
| Subject | Vincristine | Small molecule | — | Intravenous |
| Subject | dasatinib anhydrous | Small molecule | 70 mg | Oral |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | 600 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | — | Intravenous |
| Comparator | Prednisone | Other / unclassified | — | Oral |