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

Sequential Regimen of Bendamustin [B] Followed by GA101 and Ibrutinib [I] in CLL Patients

Phase 2

Completed

Conditions: Chronic Lymphocytic Leucemia

Interventions: Drug: Bendamustine
Drug: GA101
Drug: Ibrutinib

First Posted Date: 2015-01-26

Last Posted Date: 2019-05-08

Lead Sponsor: German CLL Study Group

Target Recruit Count: 66

Registration Number: NCT02345863

Locations: 🇩🇪
German CLL Study Group, Cologne, Germany

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

Phase 1

Terminated

Conditions: B-Cell Chronic Lymphocytic Leukemia

Interventions: Drug: Chlorambucil
Drug: Obinutuzumab
Drug: Placebo
Other: Standard Premedication
Drug: Tocilizumab

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

Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: RO6958688
Drug: Tocilizumab
Drug: Obinutuzumab

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)

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Bendamustine
Drug: Obinutuzumab

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

Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: GA101
Drug: ibrutinib

First Posted Date: 2014-12-12

Last Posted Date: 2023-11-29

Lead Sponsor: University of California, San Diego

Target Recruit Count: 32

Registration Number: NCT02315768

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States

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

Phase 1

Active, not recruiting

Conditions: Prolymphocytic Leukemia
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: acalabrutinib
Drug: Obinutuzumab
Drug: Venetoclax
Drug: Rituximab

First Posted Date: 2014-11-21

Last Posted Date: 2025-02-20

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)

Phase 1

Terminated

Conditions: Lymphoma, Small Lymphocytic
Lymphocytic Leukemia, Chronic

Interventions: Drug: IPI-145 (duvelisib)
Drug: Obinutuzumab

First Posted Date: 2014-11-17

Last Posted Date: 2023-02-27

Lead Sponsor: SecuraBio

Target Recruit Count: 3

Registration Number: NCT02292225

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Phase 3

Completed

Conditions: Chronic Lymphocytic Leukemia
Small-Cell Lymphoma

Interventions: Drug: Ibrutinib
Drug: Obinutuzumab
Drug: Chlorambucil

First Posted Date: 2014-10-15

Last Posted Date: 2020-09-21

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 229

Registration Number: NCT02264574

Locations: 🇬🇧
Site Reference ID/Investigator# 0867, Harlow, Essex, United Kingdom
🇦🇺
Site Reference ID/Investigator# 0888, Ballarat, Victoria, Australia
🇦🇹
Site Reference ID/Investigator# 0869, Salzburg, Austria

and more 68 locations

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma

Interventions: Drug: Bendamustine
Drug: Obinutuzumab
Drug: Polatuzumab vedotin (Liquid)
Drug: Polatuzumab vedotin (Lyophilized)
Drug: Rituximab

First Posted Date: 2014-10-06

Last Posted Date: 2022-11-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 331

Registration Number: NCT02257567

Locations: 🇳🇱
UMC St. Radboud; Hematology, Nijmegen, Netherlands
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Swedish Cancer Inst., Seattle, Washington, United States

and more 59 locations

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Phase 3

Active, not recruiting

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Venetoclax
Drug: Chlorambucil
Drug: Obinutuzumab

First Posted Date: 2014-09-17

Last Posted Date: 2025-02-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 445

Registration Number: NCT02242942

Locations: 🇦🇺
Tweed Hospital, Tweed Heads, New South Wales, Australia
🇦🇺
The Townsville Hospital, Douglas, Queensland, Australia
🇦🇺
Princess Alexandra Hospital Woolloongabba, Woolloongabba, Queensland, Australia

and more 110 locations

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