drugset / Trial / NCT02269085

Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

NCT02269085

NaSingle-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
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

Indications