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

Clinical Trials

Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

Phase 3

Recruiting

Conditions: CLL

Interventions: Drug: Sonrotoclax
Drug: Venetoclax
Drug: Zanubrutinib
Drug: Obinutuzumab

First Posted Date: 2023-10-10

Last Posted Date: 2025-05-16

Lead Sponsor: BeiGene

Target Recruit Count: 652

Registration Number: NCT06073821

Locations: 🇺🇸
Alaska Oncology and Hematology, Llc, Anchorage, Alaska, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States
🇺🇸
University of California San Diego (Ucsd) Moores Cancer Center, La Jolla, California, United States

and more 207 locations

Acalabrutinib, Obinutuzumab, and Glofitamab for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Acalabrutinib
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Biological: Glofitamab
Procedure: Multigated Acquisition Scan
Biological: Obinutuzumab
Procedure: Positron Emission Tomography

First Posted Date: 2023-09-26

Last Posted Date: 2024-12-31

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 40

Registration Number: NCT06054776

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Ph 2 Study of Glofitamab Alone or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's Transformation

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Richter's Transformation

Interventions: Drug: Glofitamab
Drug: Obinutuzumab
Drug: Tocilizumab
Drug: Polatuzumab Vedotin
Drug: Atezolizumab

First Posted Date: 2023-09-21

Last Posted Date: 2024-12-27

Lead Sponsor: Christine Ryan

Target Recruit Count: 66

Registration Number: NCT06043674

Locations: 🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

and more 1 locations

A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia

Phase 2

Recruiting

Conditions: Immune Thrombocytopenia
Treatment

Interventions: Drug: Obinutuzumab Injection [Gazyva]

First Posted Date: 2023-08-16

Last Posted Date: 2025-02-21

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 110

Registration Number: NCT05995054

Locations: 🇨🇳
Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin, China

Obinutuzumab in Chinese Real-world Patients With iNHL

Not yet recruiting

Conditions: Lymphomas Non-Hodgkin's B-Cell

Interventions: Drug: Obinutuzumab

First Posted Date: 2023-08-01

Last Posted Date: 2023-08-01

Lead Sponsor: Affiliated Hospital of Nantong University

Target Recruit Count: 400

Registration Number: NCT05968001

Locations: 🇨🇳
Wuxi Second People's Hospital, Wuxi, Jiangsu, China
🇨🇳
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China
🇨🇳
The First People's hospital of Changzhou, Changzhou, Jiangsu, China

and more 22 locations

A Single Arm Study of Acalabrutinib Conbimed With Obinutuzumab in Chinese Patients With Previously Untreated CLL

Not Applicable

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Acalabrutinib
Drug: Obinutuzumab

First Posted Date: 2023-07-18

Last Posted Date: 2024-05-09

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 89

Registration Number: NCT05950997

Locations: 🇨🇳
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, China

A Real-world Study of Obinutuzumab-based Therapy for Previously Untreated FL

Recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Bendamustine
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone

First Posted Date: 2023-06-12

Last Posted Date: 2023-06-12

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 332

Registration Number: NCT05899621

Locations: 🇨🇳
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.

Phase 1

Recruiting

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: maplirpacept (PF-07901801)
Drug: Glofitamab
Drug: Obinutuzumab

First Posted Date: 2023-06-09

Last Posted Date: 2025-05-16

Lead Sponsor: Pfizer

Target Recruit Count: 70

Registration Number: NCT05896163

Locations: 🇦🇺
Epworth Freemasons, Melbourne, Victoria, Australia
🇦🇺
Slade Pharmacy, Richmond, Victoria, Australia
🇮🇱
Sourasky Medical Center, Tel Aviv, Tell Abīb, Israel

and more 22 locations

Naptumomab Estafenatox in Combination With Pembrolizumab Preceded by Obinutuzumab in Patients With Urothelial Cancers

Phase 1

Withdrawn

Conditions: Urothelial Carcinoma

Interventions: Drug: Naptumomab Estafenatox
Drug: Pembrolizumab
Drug: Obinutuzumab

First Posted Date: 2023-06-08

Last Posted Date: 2024-04-12

Lead Sponsor: Weill Medical College of Cornell University

Registration Number: NCT05894447

Locations: 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States

Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

Phase 1

Recruiting

Conditions: Blastoid Variant Mantle Cell Lymphoma
Mantle Cell Lymphoma
Pleomorphic Variant Mantle Cell Lymphoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Glofitamab
Drug: Lenalidomide
Biological: Obinutuzumab
Procedure: Positron Emission Tomography
Drug: Venetoclax

First Posted Date: 2023-05-16

Last Posted Date: 2025-03-19

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 50

Registration Number: NCT05861050

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

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