NCT02187133

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

A Phase Ib Dose Escalation Trial of Carfilzomib in Combination With Bendamustine and Rituximab In Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of carfilzomib when combined with bendamustine (bendamustine hydrochloride) and rituximab in patients with relapsed or refractory non-Hodgkin's lymphoma. SECONDARY OBJECTIVES: I. To evaluate the preliminary antitumor activity of carfilzomib with bendamustine and rituximab in patients with non-Hodgkin lymphoma (dose escalation) and with specific non-Hodgkin lymphoma (NHL) subtypes (dose expansion). OUTLINE: This is a dose-escalation study of carfilzomib. Patients receive carfilzomib intravenously (IV) over 30 minutes twice weekly on days 1, 2, 8, 9, 15, and 16 or weekly on days 2, 9, and 16; bendamustine hydrochloride IV over 60 minutes on days 1 and 2; and rituximab IV over 30-90 minutes on day 9 (course 1 only) and day 1 (subsequent courses). Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 weeks for 6 months, every 3 months for 6 months, and then every 6 months thereafter.

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma

Interventions

Type	Name	Description
DRUG	Carfilzomib	Given IV; Dose Level (DL) Twice Weekly: DL -1 and DL 1: 15 mg/m\^2 Weekly: DL 1.5: 20,27,27 mg/m\^2, DL 2: 20,36,36 mg/m\^2, DL 3: 20,56,56 mg/m\^2 DL 4: 20,70,70 mg/m\^2
DRUG	Bendamustine	Given IV; Dose Level (DL) DL -1: 75 mg/m\^2 DL 1,1.5, 2, 3, and 4: 90 mg/m\^2
DRUG	Rituximab	Given IV; 375 mg/m\^2

Timeline

• Start date: 2015-05-05
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2014-07-10
• Last updated: 2021-04-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study