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

Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.

Phase 2

Terminated

Conditions: Lymphoma, B-Cell

Interventions: Drug: Obinutuzumab
Drug: Ibrutinib
Drug: CHOP

First Posted Date: 2016-02-01

Last Posted Date: 2017-03-20

Lead Sponsor: Fondazione Italiana Linfomi - ETS

Target Recruit Count: 1

Registration Number: NCT02670317

Locations: 🇮🇹
IRCCS Napoli Pascale, Napoli, Italy
🇮🇹
Ospedale San Gerardo, Monza, Italy
🇮🇹
Ospedale Maggiore della Carità, Novara, Italy

and more 26 locations

A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 1

Completed

Conditions: Lymphoma, Follicular

Interventions: Drug: Atezolizumab (MPDL3280A) [TECENTRIQ]
Drug: Lenalidomide
Drug: Obinutuzumab

First Posted Date: 2015-12-16

Last Posted Date: 2022-04-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 38

Registration Number: NCT02631577

Locations: 🇺🇸
University Miami, Miami, Florida, United States
🇫🇷
Hopital du Bocage, Dijon, France
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 13 locations

Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients with Chronic Lymphocytic Leukemia

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Drug: Ibrutinib
Biological: Obinutuzumab

First Posted Date: 2015-12-14

Last Posted Date: 2024-11-19

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 81

Registration Number: NCT02629809

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

A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

Phase 1

Terminated

Conditions: Non-Hodgkin's Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Idasanutlin
Drug: Rituximab

First Posted Date: 2015-12-09

Last Posted Date: 2020-05-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 25

Registration Number: NCT02624986

Locations: 🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States
🇩🇪
Charité Research Organisation GmbH Campus-Virchow-Klinikum, Berlin, Germany
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

and more 21 locations

Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.

Phase 1

Withdrawn

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: ibrutinib
Drug: obinutuzumab

First Posted Date: 2015-11-23

Last Posted Date: 2019-01-25

Lead Sponsor: Michael Choi

Registration Number: NCT02611908

Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia

Phase 3

Terminated

Conditions: Chronic Lymphocytic Leukemia

Interventions: Biological: Ublituximab
Biological: Obinutuzumab
Drug: Chlorambucil
Drug: TGR-1202

First Posted Date: 2015-11-23

Last Posted Date: 2024-12-13

Lead Sponsor: TG Therapeutics, Inc.

Target Recruit Count: 603

Registration Number: NCT02612311

Locations: 🇬🇧
TG Therapeutics Investigational Trial Site, Wolverhampton, United Kingdom

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

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