Low-Intensity Chemotherapy and Blinatumomab in Treating Patients With Philadelphia Chromosome Negative Relapsed or Refractory Acute Lymphoblastic Leukemia
Summary
This phase II trial studies how well low-intensity chemotherapy and blinatumomab work in treating patients with Philadelphia chromosome negative acute lymphoblastic leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as dexamethasone, filgrastim, pegfilgrastim, cyclophosphamide, methotrexate, cytarabine and vincristine sulfate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving low-intensity chemotherapy and blinatumomab may work better at treating acute lymphoblastic leukemia.
Timeline
- Start
- 2018-04-18
- Primary completion
- 2021-05-27
- Completion
- 2021-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blinatumomab | Monoclonal antibody | — | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Dexamethasone | Small molecule | — | Oral |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Subject | Vincristine | Small molecule | — | Intravenous |
| Background | Leucovorin | Small molecule | — | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |