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

A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Phase 1

Completed

Conditions: Follicular Lymphoma
Diffuse Large B-Cell Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Pinatuzumab Vedotin
Drug: Polatuzumab Vedotin
Drug: Rituximab

First Posted Date: 2012-09-25

Last Posted Date: 2020-02-21

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 231

Registration Number: NCT01691898

Locations: 🇮🇹
Azienda Ospedale San Giovanni, Torino, Piemonte, Italy
🇺🇸
Texas Oncology, P.A. - Tyler; Tyler Cancer Center, Tyler, Texas, United States
🇨🇦
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada

and more 38 locations

A Study of Venetoclax in Combination With Obinutuzumab in Participants With Chronic Lymphocytic Leukemia

Phase 1

Completed

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2012-09-14

Last Posted Date: 2020-01-10

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 82

Registration Number: NCT01685892

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States
🇺🇸
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center, Denver, Colorado, United States
🇺🇸
Weill Cornell Medical College-New York Presbyterian Hospital, New York, New York, United States

and more 7 locations

A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease

Phase 1

Completed

Conditions: Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma

Interventions: Drug: Obinutuzumab

First Posted Date: 2012-09-07

Last Posted Date: 2016-04-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 48

Registration Number: NCT01680991

A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Phase 1

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Bendamustine
Drug: Rituximab
Drug: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2012-08-24

Last Posted Date: 2020-10-14

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 84

Registration Number: NCT01671904

Locations: 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
University of California San Diego Medical Center, La Jolla, California, United States
🇫🇷
Hopital Saint Eloi, Montpellier, France

and more 9 locations

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

Phase 3

Terminated

Conditions: Diffuse Large B Cell Lymphoma CD20 Positive

Interventions: Drug: Rituximab
Drug: GA101
Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Prednisone
Drug: Bleomycin
Drug: Vindesin
Drug: Vincristine

First Posted Date: 2012-08-07

Last Posted Date: 2018-03-07

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 671

Registration Number: NCT01659099

Locations: 🇧🇪
Clinique universitaire Saint LUC, Bruxelles, Belgium
🇧🇪
CHU Ambroise Paré, Mons, Belgium
🇧🇪
Clinique Sainte Elisabeth, Namur, Belgium

and more 119 locations

A Study Comparing Obinutuzumab (RO5072759; GA101) 1000 Milligram (mg) Versus 2000 mg in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GAGE)

Phase 2

Completed

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Obinutuzumab
Drug: Corticosteroids

First Posted Date: 2011-08-11

Last Posted Date: 2017-04-17

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 80

Registration Number: NCT01414205

Locations: 🇺🇸
Arizona Oncology, Tucson, Arizona, United States
🇺🇸
Willamette Valley Cancer Ctr - 520 Country Club, Eugene, Oregon, United States
🇺🇸
Arizona Clinical Research Ctr, Tucson, Arizona, United States

and more 28 locations

A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)

Phase 2

Completed

Conditions: Lymphoma, B-Cell

Interventions: Drug: obinutuzumab
Drug: cyclophosphamide
Drug: doxorubicin
Drug: prednisone
Drug: vincristine

First Posted Date: 2011-08-11

Last Posted Date: 2018-04-25

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 100

Registration Number: NCT01414855

Locations: 🇺🇸
Norwalk Hospital, Norwalk, Connecticut, United States
🇺🇸
Onc Hem Assoc of Central IL, Peoria, Illinois, United States
🇺🇸
Florida Cancer Specialists; Saint Petersburg, Saint Petersburg, Florida, United States

and more 35 locations

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)

Phase 3

Completed

Conditions: Non-Hodgkin's Lymphoma

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

First Posted Date: 2011-04-11

Last Posted Date: 2022-08-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1401

Registration Number: NCT01332968

Locations: 🇨🇦
North York General Hospital, Toronto, Ontario, Canada
🇦🇺
St Vincent'S Hospital; Haematology, Fitzroy, Victoria, Australia
🇨🇦
Humber River Hospital, Toronto, Ontario, Canada

and more 180 locations

A Study of Obinutuzumab (GA101; RO5072759) in Combination With Chemotherapy in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL) (GALTON)

Phase 1

Completed

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Drug: Fludarabine
Drug: Bendamustine
Drug: Obinutuzumab
Drug: Cyclophosphamide

First Posted Date: 2011-02-21

Last Posted Date: 2017-02-02

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 41

Registration Number: NCT01300247

A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

Phase 3

Terminated

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: Rituximab
Drug: Obinutuzumab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone

First Posted Date: 2011-02-01

Last Posted Date: 2019-04-12

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1418

Registration Number: NCT01287741

Locations: 🇨🇦
Humber River Hospital, Toronto, Ontario, Canada
🇺🇸
UCLA - School of Medicine; Division of Hematology/Oncology, Los Angeles, California, United States
🇵🇱
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii, Gdansk, Poland

and more 232 locations

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