drugset / Trial / NCT02073097

Carfilzomib, Rituximab, and Combination Chemotherapy in Treating Patients With Diffuse Large B-Cell Lymphoma

NCT02073097

Phase 1/2 Completed 48 enrolled Case Comprehensive Cancer Center
NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of carfilzomib when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with diffuse large B-cell lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth by finding cancer cells and helping kill them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not known if carfilzomib in combination with R-CHOP is better or worse than R-CHOP alone in treating patients with diffuse large b-cell lymphoma.

Timeline

Start
2015-01-28
Primary completion
2021-07-20
Completion
2023-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Carfilzomib Other / unclassified 11 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 15 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 20 mg/m2 Intravenous
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
Background Acyclovir Small molecule 400 mg Oral
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background Prednisone Other / unclassified 100 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background Vincristine Small molecule 1.4 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 300 ug Intravenous
Background filgrastim Protein / enzyme biologic 480 ug Intravenous