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
Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2016-12-06
- Last Posted Date
- 2021-12-21
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 36
- Registration Number
- NCT02983617
- Locations
- 🇩🇪
Evangelisches Diakoniekrankenhaus Bremen Hämatologie, Bremen, Germany
🇩🇪Universitätsklinikum Heidelberg, Abteilung Innere Medizin V, Heidelberg, Germany
🇩🇪Uniklinik Köln Klinik I für Innere Medizin, Köln, Germany
Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2016-11-18
- Last Posted Date
- 2022-01-21
- Lead Sponsor
- Gilead Sciences
- Target Recruit Count
- 35
- Registration Number
- NCT02968563
- Locations
- 🇩🇪
Ambulante Krebszentrum Schaubstraße, Frankfurt, Brandenburg, Germany
🇩🇪KH Maria Hilf-Franziskushaus, Mönchengladbach, Mönchengladbach, Germany
🇩🇪Klinikum Rechts der Isar der Technischen Universität München, München, Germany
Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia
- Conditions
- Waldenstrom Macroglobulinemia
- Interventions
- First Posted Date
- 2016-11-11
- Last Posted Date
- 2023-08-29
- Lead Sponsor
- French Innovative Leukemia Organisation
- Target Recruit Count
- 50
- Registration Number
- NCT02962401
- Locations
- 🇫🇷
Project manager, Tours, France
Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2016-10-31
- Last Posted Date
- 2024-12-30
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 926
- Registration Number
- NCT02950051
- Locations
- 🇮🇱
Kaplan Medical Center, Rechovot, Israel
🇳🇱Canisius-Wilhelmina ZH, Nijmegen, Netherlands
🇳🇱Antonius Ziekenhuis Sneek, Sneek, Netherlands
A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
- First Posted Date
- 2016-09-26
- Last Posted Date
- 2022-06-28
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 50
- Registration Number
- NCT02915224
- Locations
- 🇬🇷
Attiko Hospital; Haematology Clinic, Athens, Greece
🇬🇷General Hospital G. Papanikolaou; Hematology, BMT Unit, Thessaloniki, Greece
🇬🇷AXEPA Pathology Section; A Pathology Clinic, Thessaloniki, Greece
Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Drug: AracytineDrug: Cisplatinum
- First Posted Date
- 2016-09-12
- Last Posted Date
- 2025-04-20
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Target Recruit Count
- 86
- Registration Number
- NCT02896582
- Locations
- 🇫🇷
CHU d'Angers, Angers, France
🇫🇷CHU d'Amiens, Amiens, France
🇫🇷CH d'Avignon, Avignon, France
Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients
- First Posted Date
- 2016-08-24
- Last Posted Date
- 2022-06-10
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 25
- Registration Number
- NCT02877550
- Locations
- 🇨🇭
Inselspital, Bern, Bern, Switzerland
🇨🇭Universitaetsspital Basel, Basel, Switzerland
🇨🇭Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland
Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation
- First Posted Date
- 2016-08-15
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 181
- Registration Number
- NCT02867384
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Stanford University, Palo Alto, California, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome
- Conditions
- Refractory Transformed Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaRecurrent Transformed Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaRichter Syndrome
- Interventions
- First Posted Date
- 2016-07-27
- Last Posted Date
- 2025-02-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 65
- Registration Number
- NCT02846623
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL
- Conditions
- Leukemia, Lymphocytic, Chronic
- Interventions
- First Posted Date
- 2016-05-02
- Last Posted Date
- 2023-01-17
- Lead Sponsor
- University of Ulm
- Target Recruit Count
- 41
- Registration Number
- NCT02758665
- Locations
- 🇩🇪
BAG Onkologische Gemeinschaftspraxis, Dresden, Germany
🇩🇪Universitätsklinikum Essen, Essen, Germany
🇩🇪Universitätsklinikum Freiburg, Freiburg, Germany
Drug Development Updates
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