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 Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma
- Conditions
- Lymphoma
- Interventions
- First Posted Date
- 2014-08-20
- Last Posted Date
- 2020-01-27
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 96
- Registration Number
- NCT02220842
- Locations
- 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸Sloan Kettering Cancer Center, New York, New York, United States
🇫🇷Hôpital Saint-Louis, Paris, France
A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors
- Conditions
- Solid Cancers
- Interventions
- First Posted Date
- 2014-06-25
- Last Posted Date
- 2020-05-12
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 158
- Registration Number
- NCT02174172
- Locations
- 🇺🇸
HonorHealth Research Institute - Bisgrove, Scottsdale, Arizona, United States
🇺🇸UCLA, Los Angeles, California, United States
🇺🇸Yale University, New Haven, Connecticut, United States
A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2014-02-25
- Last Posted Date
- 2020-02-07
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 72
- Registration Number
- NCT02071225
- Locations
- 🇪🇸
Hospital General Universitario de Elche; Servicio de Hematologia, Elche, Alicante, Spain
🇪🇸Hospital de Cabueñes; Servicio de Hematología y Hemoterapia, Gijon, Asturias, Spain
🇪🇸Hospital De Txagorritxu; Servicio de Hematologia, Vitoria, Alava, Spain
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
- Conditions
- Lymphoma, Non-Hodgkin
- Interventions
- First Posted Date
- 2014-02-05
- Last Posted Date
- 2020-06-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 267
- Registration Number
- NCT02055820
- Locations
- 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇦🇺Royal Melbourne Hospital, Parkville, Victoria, Australia
🇦🇹Medizinische Universität Wien, Wien, Austria
CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- First Posted Date
- 2014-02-03
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 787
- Registration Number
- NCT02053610
CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- First Posted Date
- 2013-12-02
- Last Posted Date
- 2018-09-14
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 787
- Registration Number
- NCT01998880
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Lymphoma, Non Hodgkin
- Interventions
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2023-03-14
- Lead Sponsor
- Genentech, Inc.
- Target Recruit Count
- 85
- Registration Number
- NCT01992653
- Locations
- 🇫🇷
Hopital Henri Mondor, Unite Hemopathies lymphoides, Creteil, France
🇺🇸Banner MD Anderson Cancer Center, Greeley, Colorado, United States
🇺🇸The University of Alabama at Birmingham, Birmingham, Alabama, United States
Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- 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
- Chronic Lymphocytic Leukemia
- 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
- Chronic Lymphocytic Leukemia
- 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
Drug Development Updates
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