Obinutuzumab
- Generic Name
- Obinutuzumab
- Brand Names
- Gazyva, Gazyvaro
- Drug Type
- Biotech
- CAS Number
- 949142-50-1
- Unique Ingredient Identifier
- O43472U9X8
- Background
Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).
- Indication
Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.
- Associated Conditions
- Refractory Follicular Lymphoma, Previously untreated Chronic lymphocytic leukemia
A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
- First Posted Date
- 2010-02-01
- Last Posted Date
- 2020-01-13
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 413
- Registration Number
- NCT01059630
- Locations
- 🇺🇸
South Texas Inst of Cancer, Corpus Christi, Texas, United States
🇺🇸University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
🇺🇸Hackensack University Medical Center, Hackensack, New Jersey, United States
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a)
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- First Posted Date
- 2009-11-09
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 787
- Registration Number
- NCT01010061
A Study of Obinutuzumab in Combination With Chemotherapy in Participants With CD20+ B-Cell Follicular Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- First Posted Date
- 2009-01-19
- Last Posted Date
- 2016-11-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 137
- Registration Number
- NCT00825149
GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- First Posted Date
- 2007-12-19
- Last Posted Date
- 2014-08-19
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 175
- Registration Number
- NCT00576758
A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)
- First Posted Date
- 2007-08-17
- Last Posted Date
- 2016-10-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 134
- Registration Number
- NCT00517530
Drug Development Updates
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