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
-

A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2017-03-09
Last Posted Date
2024-12-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
860
Registration Number
NCT03075696
Locations
🇵🇱

Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Terapii Komórkowych i Chorób Wewn?trznych, Wroc?aw, Poland

🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Ingalls Memorial Hospital, Harvey, Illinois, United States

and more 38 locations

Combination of Obinutuzumab and Venetoclax in Relapsed or Refractory DLBCL

First Posted Date
2016-12-09
Last Posted Date
2022-02-16
Lead Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Target Recruit Count
22
Registration Number
NCT02987400
Locations
🇦🇹

Universitätsklinik für Innere Med. III, PMU Salzburg, Salzburg, Austria

🇦🇹

Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V Hämatologie und Onkologie, Innsbruck, Austria

🇦🇹

UK Graz: Universitätsklinik für Innere Medizin; Klinische Abteilung für Hämatologie, Graz, Austria

and more 3 locations

Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)

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

and more 12 locations

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)

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

and more 11 locations

Efficacity of Idelalisib and Obinutuzumab in Patient With Relapsed Refractory Waldenstrom's Macroglobulinemia

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

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

and more 8 locations

Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance

First Posted Date
2016-09-12
Last Posted Date
2024-03-15
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

and more 27 locations

Obinutuzumab in Combination With Venetoclax in Previously Untreated Follicular Lymphoma Patients

Phase 1
Completed
Conditions
Interventions
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

and more 3 locations

Obinutuzumab in cGVHD After Allogeneic Peripheral Blood Stem Cell Transplantation

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-08-15
Last Posted Date
2024-04-17
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

and more 2 locations
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