A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+) malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated time on study treatment is 24 weeks.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Obinutuzumab

Criteria

Inclusion Criteria:

• Diagnosis of CD20+ B-cell lymphoma or B-CLL

• Refractory/relapsed CLL, FL, and DLBCL

• At least 1 measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest dimension) with the exception of CLL

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy >6 months

Exclusion Criteria:

• Prior use of any investigational antibody therapy within 6 months of study start

• Prior use of any anti-cancer vaccine

• Prior administration of rituximab within 3 months of study start

• Prior administration of radioimmunotherapy 3 months prior to study entry

• Central nervous system lymphoma

• History of other malignancy

• Evidence of significant, uncontrolled concomitant disease

• Abnormal laboratory values

• Patients with progressive multifocalleukoencephalopathy (PML)

• Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C