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
- -
Bendamustine + Obinutuzumab Induction With Obinutuzumab Maintenance in Untreated Mantle Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2017-10-16
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- University of Wisconsin, Madison
- Target Recruit Count
- 21
- Registration Number
- NCT03311126
- Locations
- 🇺🇸
University of Wisconsin Carbone Cancer Center, Madison, Wisconsin, United States
Evaluation of Atezolizumab-Venetoclax-Obinutuzumab Combination in Relapse/Refractory Lymphomas
- Conditions
- Interventions
- First Posted Date
- 2017-09-08
- Last Posted Date
- 2023-01-10
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Target Recruit Count
- 136
- Registration Number
- NCT03276468
- Locations
- 🇫🇷
CHU de Caen, Caen, France
🇫🇷CHRU de Lille, Lille, France
🇫🇷CHU d'Angers, Angers, France
Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma
- Conditions
- Interventions
- Procedure: BiopsyDrug: Bendamustine HydrochlorideProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: EchocardiographyProcedure: Multigated Acquisition ScanDrug: LenalidomideDrug: CyclophosphamideBiological: ObinutuzumabDrug: Doxorubicin HydrochlorideProcedure: Positron Emission TomographyDrug: UmbralisibDrug: PrednisoneDrug: Vincristine Sulfate
- First Posted Date
- 2017-09-01
- Last Posted Date
- 2024-11-12
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 95
- Registration Number
- NCT03269669
- Locations
- 🇺🇸
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
🇺🇸Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
🇺🇸Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States
Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse
- First Posted Date
- 2017-07-25
- Last Posted Date
- 2023-08-16
- Lead Sponsor
- Polish Lymphoma Research Group
- Target Recruit Count
- 1
- Registration Number
- NCT03229382
- Locations
- 🇵🇱
Centrum Onkologii - Instytut im. Marii Skłodowskiej- Curie Klinika Nowotworów Układu Chłonnego, Warszawa, Poland
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
- First Posted Date
- 2017-07-21
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 145
- Registration Number
- NCT03223610
- Locations
- 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States
A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies
- Conditions
- Interventions
- First Posted Date
- 2017-06-26
- Last Posted Date
- 2024-06-11
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 35
- Registration Number
- NCT03198650
- Locations
- 🇯🇵
Research Site, Suita-shi, Japan
Study of Ibrutinib & Obinutuzumab With/Without CHOP for Richter's Transformation or Richter's Syndrome Patients
- Conditions
- Interventions
- First Posted Date
- 2017-05-09
- Last Posted Date
- 2023-06-01
- Lead Sponsor
- Northwell Health
- Target Recruit Count
- 3
- Registration Number
- NCT03145480
- Locations
- 🇺🇸
Northwell Health/CLL Research and Treatment Program, New Hyde Park, New York, United States
A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Interventions
- First Posted Date
- 2017-05-01
- Last Posted Date
- 2021-12-07
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 29
- Registration Number
- NCT03135262
- Locations
- 🇺🇸
Mount Sinai Medical Center, New York, New York, United States
🇦🇺Prince of Wales Hospital, Randwick, New South Wales, Australia
🇦🇺Westmead Hospital, Westmead, New South Wales, Australia
Obinutuzumab, High Dose Methylprednisolone (HDMP), and Lenalidomide for the Treatment of Patients With Richter's Syndrome
- Conditions
- Interventions
- First Posted Date
- 2017-04-13
- Last Posted Date
- 2022-07-05
- Lead Sponsor
- University of California, San Diego
- Target Recruit Count
- 4
- Registration Number
- NCT03113695
- Locations
- 🇺🇸
University of California, San Diego, La Jolla, California, United States
Single Agent Obinutuzumab in Relapsed/Refractory Post-Transplant Lymphoproliferative Disorder (PTLD)
- Conditions
- Interventions
- First Posted Date
- 2017-03-22
- Last Posted Date
- 2017-03-22
- Lead Sponsor
- Case Comprehensive Cancer Center
- Registration Number
- NCT03086395
Drug Development Updates
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