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: -

Clinical Trials

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

Phase 2

Completed

Conditions: Waldenstrom Macroglobulinemia

Interventions: Drug: Obinutuzumab
Drug: Idelalisib

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

Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

Phase 3

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Fludarabine
Biological: Obinutuzumab
Drug: Cyclophosphamide
Drug: Venetoclax
Biological: Rituximab
Drug: Ibrutinib
Drug: Bendamustine

First Posted Date: 2016-10-31

Last Posted Date: 2024-12-30

Lead Sponsor: German CLL Study Group

Target Recruit Count: 926

Registration Number: NCT02950051

Locations: 🇮🇱
Kaplan Medical Center, Rechovot, Israel
🇳🇱
Canisius-Wilhelmina ZH, Nijmegen, Netherlands
🇳🇱
Antonius Ziekenhuis Sneek, Sneek, Netherlands

and more 158 locations

A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Chlorambucil
Drug: Obinutuzumab

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

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Dexamethasone
Drug: Aracytine
Drug: Cisplatinum
Drug: Etoposide
Drug: Melphalan
Drug: Carmustine

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: Follicular Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Venetoclax

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: Graft vs. Host Disease

Interventions: Drug: Placebo
Drug: Obinutuzumab

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

Atezolizumab, Obinutuzumab, and Venetoclax in Treating Patients With Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Relapsed or Refractory Richter Syndrome

Phase 2

Recruiting

Conditions: Refractory Transformed Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Recurrent Transformed Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Richter Syndrome

Interventions: Drug: Atezolizumab
Other: Laboratory Biomarker Analysis
Biological: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2016-07-27

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 65

Registration Number: NCT02846623

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Trial of Ibrutinib Plus Venetoclax Plus Obinutuzumab in Patients With CLL

Phase 2

Completed

Conditions: Leukemia, Lymphocytic, Chronic

Interventions: Drug: ibrutinib
Drug: obinutuzumab
Drug: venetoclax

First Posted Date: 2016-05-02

Last Posted Date: 2023-01-17

Lead Sponsor: University of Ulm

Target Recruit Count: 41

Registration Number: NCT02758665

Locations: 🇩🇪
BAG Onkologische Gemeinschaftspraxis, Dresden, Germany
🇩🇪
Universitätsklinikum Essen, Essen, Germany
🇩🇪
Universitätsklinikum Freiburg, Freiburg, Germany

and more 8 locations

Obinutuzumab in Combination With GDP Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin's

Interventions: Drug: Obinutuzumab
Drug: Gemcitabine
Drug: Dexamethasone
Drug: Cisplatin

First Posted Date: 2016-04-25

Last Posted Date: 2021-04-13

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 30

Registration Number: NCT02750670

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Lymphoma

Interventions: Drug: Atezolizumab [TECENTRIQ]
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Rituximab

First Posted Date: 2016-04-06

Last Posted Date: 2020-12-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 36

Registration Number: NCT02729896

Locations: 🇵🇱
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw, Poland
🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸
University Miami, Miami, Florida, United States

and more 16 locations

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