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
- -
An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2018-05-23
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 211
- Registration Number
- NCT03533283
- Locations
- 🇧🇪
UZ Gent, Gent, Belgium
🇺🇸Novant Health Cancer Institute, Charlotte, North Carolina, United States
🇩🇰Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, Denmark
Acalabrutinib with or Without Obinutuzumab in Treating Patients with Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- First Posted Date
- 2018-05-04
- Last Posted Date
- 2024-11-08
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 120
- Registration Number
- NCT03516617
- Locations
- 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸Mayo Clinic in Rochester, Rochester, Minnesota, United States
A Study Of The Selective PKC-β Inhibitor MS- 553
- Conditions
- Interventions
- First Posted Date
- 2018-04-10
- Last Posted Date
- 2024-07-18
- Lead Sponsor
- MingSight Pharmaceuticals, Inc
- Target Recruit Count
- 63
- Registration Number
- NCT03492125
- Locations
- 🇺🇸
University Of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸Columbia University, Herbert Irving Comprehensive Cancer Center, New York, New York, United States
🇺🇸MD Anderson Cancer Center, Department of Leukemia, Houston, Texas, United States
First Line Therapy of Advanced Stage Follicular Lymphoma in Patients < 60 Years Not Eligible fo Standard Immunochemotherapy and in All Patients ≥ 60 Years
- Conditions
- Interventions
- First Posted Date
- 2018-04-10
- Last Posted Date
- 2023-03-31
- Lead Sponsor
- Prof. Dr. Wolfgang Hiddemann
- Target Recruit Count
- 46
- Registration Number
- NCT03492775
- Locations
- 🇩🇪
Klinikum der Universität München, München, Bavaria, Germany
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- Conditions
- Interventions
- First Posted Date
- 2018-03-12
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 211
- Registration Number
- NCT03462719
- Locations
- 🇨🇦
Arthur J E Child Comprehensive Cancer Centre, Calgary, Alberta, Canada
🇺🇸Norton Cancer Institute, Louisville, Kentucky, United States
🇺🇸John Theurer Cancer Center, Hackensack, New Jersey, United States
A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
- Conditions
- Interventions
- First Posted Date
- 2018-01-25
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 30
- Registration Number
- NCT03410875
- Locations
- 🇺🇸
Memorial Sloan Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸Memorial Sloan Kettering Cancer Center @ Commack (Limited Protocol Activities), Commack, New York, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
A Study in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Subjects, Excluding Those With the 17p Deletion, to Evaluate Debulking Regimens Prior to Initiating Venetoclax Combination Therapy
- Conditions
- Interventions
- First Posted Date
- 2018-01-23
- Last Posted Date
- 2024-08-06
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 120
- Registration Number
- NCT03406156
- Locations
- 🇺🇸
Oncology Hematology Care, Inc. /ID# 202397, Cincinnati, Ohio, United States
🇺🇸Tennessee Oncology-Nashville Centennial /ID# 201098, Nashville, Tennessee, United States
🇺🇸Arizona Oncology Associates, PC-HOPE /ID# 202335, Tempe, Arizona, United States
A Study of Atezolizumab in Combination With an Immunotherapy Agent Investigated With or Without Anti-Cd20 Therapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2017-12-12
- Last Posted Date
- 2018-04-05
- Lead Sponsor
- Hoffmann-La Roche
- Registration Number
- NCT03369964
- Locations
- 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸Tennessee Oncology, Nashville, Tennessee, United States
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2017-11-06
- Last Posted Date
- 2024-10-26
- Lead Sponsor
- BeiGene
- Target Recruit Count
- 217
- Registration Number
- NCT03332017
- Locations
- 🇺🇸
Emory University Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸University of Illinois At Chicago, Chicago, Illinois, United States
🇺🇸Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Obinutuzumab in Marginal Zone Lymphoma
- First Posted Date
- 2017-10-26
- Last Posted Date
- 2023-08-24
- Lead Sponsor
- Christian Buske
- Target Recruit Count
- 56
- Registration Number
- NCT03322865
- Locations
- 🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany
🇩🇪University Hospital Essen, Essen, Germany
🇩🇪University Hospital Ulm, Ulm, Germany
Drug Development Updates
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