NCT00633594

Rituximab, Lenalidomide, and Bortezomib in Mantle Cell Lymphoma

Phase I/II Study Evaluating Rituximab, Lenalidomide, and Bortezomib in the First-Line or Second-Line Treatment of Patients With Mantle Cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II multicenter, open-label, dose-escalation study of rituximab, bortezomib, and lenalidomide in the first-line or second-line treatment of patients with Mantle Cell Lymphoma (MCL).

Detailed description

The combination of lenalidomide with bortezomib has not been studied in patients with MCL, but feasibility and tolerability has been demonstrated in patients with multiple myeloma. Thus, almost every 2-drug combination of rituximab, lenalidomide, and bortezomib has been tested, or is being tested. We hypothesize that all three drugs are important in MCL, and therefore propose to combine all 3 agents (rituximab, bortezomib, and lenalidomide) in a schedule that is convenient to lymphoma patients. Approximately 18 patients may be enrolled in the Phase I portion of the study. Approximately 45 patients are planned for enrollment in Phase II.

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	DL 1, DL 2, and DL 3: 375 mg/m2 IV Days 1, 8, and 15; Cycles 2-6: 375 mg/m2 IV Day 1 Same for DL-1.
DRUG	Bortezomib	DL 1, DL 2, and DL 3: 1.3 mg/m2 IV Days 1, 4, 8, and 11 Same for DL-1.
DRUG	Lenalidomide	DL 1: 15 mg PO daily Days 1-14 followed by 7 days of rest DL 2: 20 mg PO daily Days 1-14 followed by 7 days of rest DL 3: 25 mg PO daily Days 1-14 followed by 7 days of rest DL-1: 10 mg PO daily Days 1-14 followed by 7 days of rest

Timeline

• Start date: 2008-06-01
• Primary completion: 2015-04-01
• Completion: 2016-11-01
• First posted: 2008-03-12
• Last updated: 2017-01-31
• Results posted: 2017-01-31

Locations

7 sites across 1 country: United States