drugset / Trial / NCT01729104

Phase I/II Carfilzomib Plus Lenalidomide and Rituximab in the Treatment of Relapsed/Refractory Mantle Cell Lymphoma

NCT01729104

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of Part 1 of this clinical research study is to find the highest tolerable dose of carfilzomib that can be given in combination with lenalidomide and rituximab to patients with relapsed or refractory B-cell non-hodgkin lymphoma. The goal of Part 2 of this study is to learn if the drug combination can help to control B-cell non-hodgkin lymphoma. The safety of this drug combination will be studied in both parts. Carfilzomib is designed to keep cancer cells from repairing themselves. If the cancer cells cannot repair themselves, this may cause them to die. Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. This may decrease the growth of cancer cells. Rituximab is designed to attach to cancer cells and damage them, which may cause the cancer cells to die. It is also designed to cause the immune system to attack cancer cells.

Timeline

Start
2013-04-25
Primary completion
2018-10-03
Completion
2018-10-03

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 Lenalidomide Other / unclassified 20 mg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications