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

Roche

Status and phase: Completed; Phase 1

Conditions: Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma

Treatments: Drug: Obinutuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01680991

YP25623

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

CLL: 1000 mg Obinutuzumab

Experimental group

Description:

Participants with chronic lymphocytic leukemia (CLL) will receive 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. The first infusion on Cycle 1 Day 1 will be given over two days: Day 1 and Day 2. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Treatment:

Drug: Obinutuzumab

DLBCL: 1000 mg Obinutuzumab

Experimental group

Description:

Participants with diffuse large B-cell lymphoma (DLBCL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Treatment:

Drug: Obinutuzumab

FL: 1000 mg Obinutuzumab

Experimental group

Description:

Participants with follicular lymphoma (FL) will receive 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab will be administered on Cycle 1 Day 8 and Day 15.

Treatment:

Drug: Obinutuzumab