NCT00575068

Safety and Efficacy of IDEC-114 in the Treatment of Non-Hodgkin's Lymphoma

A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	IDEC-114	Phase 1-A Group 1 - 125 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 2 - 250 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-A Group 3 - 375 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase 1-B Group 4 - 500 mg/m2 x 4 infusions - Study Days 1, 8, 15, 22 Phase II-A \& II-B - Dosage start at the MTD (up to 375 mg/m2)

Timeline

• Start date: 2002-01-01
• Primary completion: 2002-09-01
• Completion: 2010-11-01
• First posted: 2007-12-17
• Last updated: 2012-06-08

Locations

4 sites across 1 country: United States