Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma
Summary
The goal of this clinical research study is to find the highest tolerable dose of carfilzomib and ibrutinib that can be given to patients with relapsed or refractory MCL. Researchers also want to learn if carfilzomib and ibrutinib can help to control the disease. This is an investigational study. Ibrutinib is FDA approved and commercially available to treat MCL and chronic lymphocytic leukemia (CLL). Carfilzomib is FDA approved and commercially available to treat certain types of multiple myeloma. Giving carfilzomib to patients with MCL is investigational. The combination of ibrutinib and carfilzomib is investigational. The study doctor can explain how the study drugs are designed to work. Up to 35 participants will be enrolled on this study. All will be enrolled at MD Anderson.
Timeline
- Start
- 2015-04-20
- Primary completion
- 2018-05-29
- Completion
- 2018-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carfilzomib | Other / unclassified | 27 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 36 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 45 mg/m2 | Intravenous |
| Subject | Carfilzomib | Other / unclassified | 56 mg/m2 | Intravenous |
| Subject | Ibrutinib | Small molecule | 420 mg | Oral |
| Subject | Ibrutinib | Small molecule | 560 mg | Oral |