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 Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Rituximab
Drug: Polatuzumab Vedotin
Drug: Venetoclax

First Posted Date: 2015-11-20

Last Posted Date: 2023-10-10

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 133

Registration Number: NCT02611323

Locations: 🇮🇹
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Emilia-Romagna, Italy
🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
🇮🇹
SCDU Ematologia, Novara, Piemonte, Italy

and more 20 locations

A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Interventions: Drug: Lenalidomide
Drug: Obinutuzumab
Drug: Polatuzumab Vedotin
Drug: Rituximab

First Posted Date: 2015-11-09

Last Posted Date: 2023-12-26

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 114

Registration Number: NCT02600897

Locations: 🇬🇧
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, United Kingdom
🇬🇧
Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone, United Kingdom
🇬🇧
Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital, Romford, United Kingdom

and more 25 locations

A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1

Completed

Conditions: Diffuse Large B-Cell Lymphoma, Lymphoma Follicular

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

First Posted Date: 2015-11-04

Last Posted Date: 2021-05-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 91

Registration Number: NCT02596971

Locations: 🇦🇺
Concord Repatriation General Hospital; Haematology, Sydney, New South Wales, Australia
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute, Springfield, Oregon, United States

and more 18 locations

A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation

Phase 1

Completed

Conditions: Kidney Failure, Chronic

Interventions: Drug: Obinutuzumab
Drug: Intravenous Immunoglobulin

First Posted Date: 2015-10-26

Last Posted Date: 2020-01-29

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 24

Registration Number: NCT02586051

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
UCSF, San Francisco, California, United States
🇺🇸
Mayo Clinic - Minnesota, Rochester, Minnesota, United States

and more 6 locations

BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies

Phase 1

Completed

Conditions: B-cell Lymphoid Malignancies

Interventions: Drug: Zanubrutinib
Drug: Obinutuzumab

First Posted Date: 2015-10-06

Last Posted Date: 2024-10-26

Lead Sponsor: BeiGene

Target Recruit Count: 119

Registration Number: NCT02569476

Locations: 🇺🇸
Florida Cancer Specialists Fort Myers, Fort Myers, Florida, United States
🇺🇸
Florida Cancer Specialists East, West Palm Beach, Florida, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States

and more 11 locations

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

Phase 2

Completed

Conditions: Lupus Nephritis

Interventions: Drug: Mycophenolate Mofetil/Mycophenolic Acid
Other: Placebo
Drug: Obinutuzumab
Drug: Methylprednisolone
Drug: Prednisone

First Posted Date: 2015-09-15

Last Posted Date: 2024-08-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 126

Registration Number: NCT02550652

Locations: 🇺🇸
Emory Uni ; Division of Rheumatology, Atlanta, Georgia, United States
🇺🇸
Univ of California, San Diego, La Jolla, California, United States
🇺🇸
Stanford University Medical Center, Palo Alto, California, United States

and more 43 locations

A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Obinutuzumab
Drug: Ibrutinib

First Posted Date: 2015-09-01

Last Posted Date: 2025-02-05

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 54

Registration Number: NCT02537613

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma

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

First Posted Date: 2015-08-20

Last Posted Date: 2022-11-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 59

Registration Number: NCT02529852

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

GOAL: GA101 Plus Pixantrone for Relapsed Aggressive Lymphoma

Phase 2

Completed

Conditions: Lymphoma, Non-Hodgkin

Interventions: Drug: Obinutuzumab and Pixantrone

First Posted Date: 2015-07-15

Last Posted Date: 2022-03-31

Lead Sponsor: Johannes Gutenberg University Mainz

Target Recruit Count: 70

Registration Number: NCT02499003

Locations: 🇩🇪
Department of Hematology, Oncology and Pneumology; University Medical Center of the Johannes Gutenberg-University, Mainz, RLP, Germany

GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma

Phase 2

Terminated

Conditions: Elderly Unfit Patients
CD20 Positive Diffuse Large B-cell Lymphoma

Interventions: Drug: Ga101

First Posted Date: 2015-07-13

Last Posted Date: 2020-11-05

Lead Sponsor: Fondazione Italiana Linfomi - ETS

Target Recruit Count: 34

Registration Number: NCT02495454

Locations: 🇮🇹
Asmn-Irccs, Reggio Emilia, RE, Italy
🇮🇹
Ematologia 1U - AO Città della Salute e della Scienza, Torino, TO, Italy
🇮🇹
A.O. S. Maria di Terni, Terni, TR, Italy

and more 13 locations

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