Clinical trial · Interventional
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease
A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Pharmacokinetics of RO5072759 in Chinese Patients With CD20+ Malignant Disease
NCT01680991CI-TRIAL-00021903completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma | Lymphoid Leukemia | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- CLL: 1000 mg Obinutuzumab
- 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.
- interventionNames
- Drug: Obinutuzumab
- type
- EXPERIMENTAL
- label
- DLBCL: 1000 mg Obinutuzumab
- 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.
- interventionNames
- Drug: Obinutuzumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDQin Y, Song Y, Shen Z, Du X, Ji W, Hsu W, Zhu J, Shi Y. Safety and efficacy of obinutuzumab in Chinese patients with B-cell lymphomas: a secondary analysis of the GERSHWIN trial. Cancer Commun (Lond). 2018 May 30;38(1):31. doi: 10.1186/s40880-018-0300-5. PMID 29843792
- DERIVEDZhai J, Qin Y, Zhu J, Song Y, Shen Z, Du X, Jamois C, Brewster M, Shi Y, Shi J. Pharmacokinetics of obinutuzumab in Chinese patients with B-cell lymphomas. Br J Clin Pharmacol. 2017 Jul;83(7):1446-1456. doi: 10.1111/bcp.13232. Epub 2017 Feb 14. PMID 28072473