drugset / Trial / NCT02187133

Carfilzomib With Bendamustine and Rituximab in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT02187133

NaSingle-groupOpen-labelTreatment

Summary

This study will be conducted as a Phase Ib, open-label, non-randomized, single-institution study to evaluate the safety and tolerability of carfilzomib in combination with bendamustine and rituximab in patients with relapsed or refractory NHL and to determine the recommended phase II dose and preliminary efficacy of this combination. The study will have two phases: a dose-escalation phase to determine the maximal tolerated dose of carfilzomib in this combination where participants will be monitored for toxicity, tolerability and response and a dose-expansion phase that will determine the preliminary efficacy in patients with Mantle cell lymphoma or any other disease subtype in which there is a preliminary efficacy signal observed.

Timeline

Start
2015-05-05
Primary completion
2021-03-31
Completion
2021-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 75 mg/m2 Intravenous
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 15 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 27 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 36 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 56 mg/m2 Intravenous
Subject Carfilzomib Other / unclassified 70 mg/m2 Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications