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 Le...

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
-

A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.

First Posted Date
2015-04-15
Last Posted Date
2023-10-23
Lead Sponsor
Celgene
Target Recruit Count
75
Registration Number
NCT02417285
Locations
🇳🇱

Local Institution - 201, Amsterdam, Netherlands

🇳🇱

Local Institution - 202, Rotterdam, Netherlands

🇫🇷

Local Institution - 105, Borddeaux Cedex, France

and more 5 locations

A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

First Posted Date
2015-04-02
Last Posted Date
2021-09-20
Lead Sponsor
Celgene
Target Recruit Count
47
Registration Number
NCT02406742
Locations
🇺🇸

Hackensack University Medical Center, Hackensack, New Jersey, United States

🇦🇹

University Hospital of Salzburg St Johanns Spital, Salzburg, Austria

🇺🇸

The West Clinic, Memphis, Tennessee, United States

and more 21 locations

Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL

First Posted Date
2015-03-19
Last Posted Date
2023-10-26
Lead Sponsor
New York Medical College
Target Recruit Count
25
Registration Number
NCT02393157
Locations
🇺🇸

New York Medical College, Valhalla, New York, United States

A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

First Posted Date
2015-03-18
Last Posted Date
2023-09-28
Lead Sponsor
SecuraBio
Target Recruit Count
55
Registration Number
NCT02391545

Lenalidomide and Obinutuzumab for Previously Untreated CLL

First Posted Date
2015-02-25
Last Posted Date
2018-02-23
Lead Sponsor
University of California, San Diego
Registration Number
NCT02371590
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities

First Posted Date
2015-01-12
Last Posted Date
2021-04-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
38
Registration Number
NCT02336048
Locations
🇪🇸

Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, Spain

🇪🇸

Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, Spain

🇮🇹

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy

and more 11 locations

A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors

First Posted Date
2014-12-24
Last Posted Date
2020-04-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
149
Registration Number
NCT02324257
Locations
🇺🇸

Cedars Sinai Medical Center; Samuel-Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

🇪🇸

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, Spain

🇺🇸

Stanford University, Palo Alto, California, United States

and more 18 locations

A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)

First Posted Date
2014-12-19
Last Posted Date
2020-02-11
Lead Sponsor
Genentech, Inc.
Target Recruit Count
102
Registration Number
NCT02320487
Locations
🇺🇸

Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States

🇺🇸

Cancer Care & Hematology; Specialists of Chicagoland, Niles, Illinois, United States

🇺🇸

San Juan Oncology Associates, Farmington, New Mexico, United States

and more 23 locations

Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL

First Posted Date
2014-11-21
Last Posted Date
2024-11-27
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
69
Registration Number
NCT02296918
Locations
🇺🇸

Research Site, Columbus, Ohio, United States

Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

First Posted Date
2014-11-17
Last Posted Date
2023-02-27
Lead Sponsor
SecuraBio
Target Recruit Count
3
Registration Number
NCT02292225
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