Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma
Summary
The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
Timeline
- Start
- 2019-03-13
- Primary completion
- 2021-03-12
- Completion
- 2024-02-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mivavotinib | Small molecule | 60 mg | Oral |
| Subject | mivavotinib | Small molecule | 80 mg | Oral |
| Subject | mivavotinib | Small molecule | 100 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Doxorubicin | Other / unclassified | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Rituximab | Monoclonal antibody | — | Intravenous |
| Background | Vincristine | Small molecule | — | Intravenous |