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 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
- Associated Therapies
- -
Idelalisib+Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma
- First Posted Date
- 2019-03-26
- Last Posted Date
- 2024-11-21
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Target Recruit Count
- 5
- Registration Number
- NCT03890289
- Locations
- 🇮🇹
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia, Firenze, Italy
🇮🇹AOU Maggiore della Carità di Novara - SCDU Ematologia, Novara, Italy
🇮🇹Azienda sanitaria-universitaria integrata Trieste (ASUITS) - SC Ematologia, Trieste, Italy
A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma
- Conditions
- Interventions
- First Posted Date
- 2019-03-07
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 47
- Registration Number
- NCT03866239
- Locations
- 🇫🇷
Centre Leon Berard; Departement Oncologie Medicale, Lyon, France
🇺🇸Stanford Comprehensive Cancer Center, Stanford, California, United States
🇪🇸START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, Spain
Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL
- Conditions
- Interventions
- First Posted Date
- 2019-02-11
- Last Posted Date
- 2024-09-30
- Lead Sponsor
- Acerta Pharma BV
- Target Recruit Count
- 984
- Registration Number
- NCT03836261
- Locations
- 🇬🇧
Research Site, Wolverhampton, United Kingdom
Study of Zanubrutinib, Obinutuzumab, and Venetoclax in Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL)
- Conditions
- Interventions
- First Posted Date
- 2019-01-31
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 230
- Registration Number
- NCT03824483
- Locations
- 🇺🇸
Northwestern University, Evanston, Illinois, United States
🇺🇸Massachusetts General Hospital (Data Collection and Specimen Analysis), Boston, Massachusetts, United States
🇺🇸Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
An Open-Label, Single Arm Study of Obinutuzumab Short Duration Infusion in Patients With Previously Untreated Advanced Follicular Lymphoma
- First Posted Date
- 2019-01-28
- Last Posted Date
- 2024-04-04
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 114
- Registration Number
- NCT03817853
- Locations
- 🇳🇱
Albert Schweitzer Ziekenhuis - loc Dordrecht, Dordrecht, Netherlands
🇧🇷NOHC - Núcleo de Oncologia e Hematologia do Ceará, Fortaleza, CE, Brazil
🇺🇸San Juan Oncology Associates, Farmington, New Mexico, United States
Ibrutinib, Obinutuzumab and Venetoclax for Patients With Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2018-11-28
- Last Posted Date
- 2021-02-02
- Lead Sponsor
- Grupo Cooperativo de Hemopatías Malignas
- Target Recruit Count
- 3
- Registration Number
- NCT03755947
- Locations
- 🇲🇽
Grupo Cooperativo de Hemopatías Malignas, Huixquilucan, Estado De México, Mexico
Testing The Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2018-11-13
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 454
- Registration Number
- NCT03737981
- Locations
- 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸Mercy Health - Perrysburg Hospital, Perrysburg, Ohio, United States
🇺🇸University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia
- First Posted Date
- 2018-10-10
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 720
- Registration Number
- NCT03701282
- Locations
- 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States
🇺🇸Mercy Health - Perrysburg Hospital, Perrysburg, Ohio, United States
Acalabrutinib, Venetoclax, and Obinutuzumab for Initial Therapy of CLL
- Conditions
- Interventions
- First Posted Date
- 2018-07-10
- Last Posted Date
- 2024-07-30
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 72
- Registration Number
- NCT03580928
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Stamford Hospital/Bennett Cancer Center, Stamford, Connecticut, United States
🇺🇸Lifespan Cancer Institute, Providence, Rhode Island, United States
A Study of RO7172508 in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2018-05-29
- Last Posted Date
- 2020-09-03
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 26
- Registration Number
- NCT03539484
- Locations
- 🇨🇦
Princess Margaret Cancer Center, Toronto, Ontario, Canada
🇪🇸Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
🇪🇸Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, Spain
Drug Development Updates
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