Obinutuzumab
- Generic Name
- Obinutuzumab
- Brand Names
- Gazyva, Gazyvaro
- Drug Type
- Biotech
- Chemical Formula
- -
- 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 Le...
- 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
- Associated Therapies
- -
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2013-11-11
- Last Posted Date
- 2018-11-19
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 57
- Registration Number
- NCT01980875
- Locations
- 🇺🇸
Sansum Clinic, Santa Barbara, California, United States
🇺🇸Innovative Clinical Research Institute, Whittier, California, United States
🇫🇷Centre Hospitalier de Perpignan, Perpignan Cedex 9, France
A Safety and Efficacy Study of Obinutuzumab Alone or in Combination With Chemotherapy in Participants With Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2013-07-23
- Last Posted Date
- 2019-10-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 979
- Registration Number
- NCT01905943
- Locations
- 🇧🇷
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
🇧🇷Hospital de Cancer de Barretos, Barretos, SP, Brazil
🇧🇷Hospital Amaral Carvalho, Jau, SP, Brazil
An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2013-06-05
- Last Posted Date
- 2017-04-17
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 20
- Registration Number
- NCT01868893
- Locations
- 🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸Cancer Center of Central Conn., Southington, Connecticut, United States
🇺🇸Peachtree Hematology & Oncology Consultants, Pc, Atlanta, Georgia, United States
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
- Conditions
- Interventions
- First Posted Date
- 2012-09-25
- Last Posted Date
- 2020-02-21
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 231
- Registration Number
- NCT01691898
- Locations
- 🇮🇹
Azienda Ospedale San Giovanni, Torino, Piemonte, Italy
🇺🇸Texas Oncology, P.A. - Tyler; Tyler Cancer Center, Tyler, Texas, United States
🇨🇦McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada
A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2012-09-14
- Last Posted Date
- 2020-01-10
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 82
- Registration Number
- NCT01685892
- Locations
- 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center, Denver, Colorado, United States
🇺🇸Weill Cornell Medical College-New York Presbyterian Hospital, New York, New York, United States
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease
- Conditions
- Interventions
- First Posted Date
- 2012-09-07
- Last Posted Date
- 2016-04-25
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 48
- Registration Number
- NCT01680991
A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Interventions
- First Posted Date
- 2012-08-24
- Last Posted Date
- 2020-10-14
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 84
- Registration Number
- NCT01671904
- Locations
- 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸University of California San Diego Medical Center, La Jolla, California, United States
🇫🇷Hopital Saint Eloi, Montpellier, France
A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)
- Conditions
- Interventions
- First Posted Date
- 2011-08-11
- Last Posted Date
- 2017-04-17
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 80
- Registration Number
- NCT01414205
- Locations
- 🇺🇸
Arizona Oncology, Tucson, Arizona, United States
🇺🇸Willamette Valley Cancer Ctr - 520 Country Club, Eugene, Oregon, United States
🇺🇸Arizona Clinical Research Ctr, Tucson, Arizona, United States
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
- Conditions
- Interventions
- First Posted Date
- 2011-08-11
- Last Posted Date
- 2018-04-25
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 100
- Registration Number
- NCT01414855
- Locations
- 🇺🇸
Norwalk Hospital, Norwalk, Connecticut, United States
🇺🇸Onc Hem Assoc of Central IL, Peoria, Illinois, United States
🇺🇸Florida Cancer Specialists; Saint Petersburg, Saint Petersburg, Florida, United States
A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
- Conditions
- Interventions
- First Posted Date
- 2011-04-11
- Last Posted Date
- 2022-08-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 1401
- Registration Number
- NCT01332968
- Locations
- 🇨🇦
North York General Hospital, Toronto, Ontario, Canada
🇦🇺St Vincent'S Hospital; Haematology, Fitzroy, Victoria, Australia
🇨🇦Humber River Hospital, Toronto, Ontario, Canada
Drug Development Updates
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