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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLL: 1000 mg Obinutuzumab

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

Multiple doses of obinutuzumab.

DLBCL: 1000 mg Obinutuzumab

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

Multiple doses of obinutuzumab.

FL: 1000 mg Obinutuzumab

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.

Group Type EXPERIMENTAL

Obinutuzumab

Intervention Type DRUG

Multiple doses of obinutuzumab.

Interventions

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Obinutuzumab

Multiple doses of obinutuzumab.

Intervention Type DRUG

Other Intervention Names

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RO5072759 GA101

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No