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

Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Phase 3

Active, not recruiting

Conditions: Chronic Lymphoid Leukemia

Interventions: Biological: Venetoclax
Biological: Ibrutinib
Biological: Obinutuzumab

First Posted Date: 2020-10-29

Last Posted Date: 2024-12-31

Lead Sponsor: German CLL Study Group

Target Recruit Count: 897

Registration Number: NCT04608318

Locations: 🇩🇪
Klinikum rechts der Isar - Technische Universitaet Muenchen, München, Germany
🇳🇱
Franciscus Vlietland, Schiedam, Netherlands
🇸🇪
Hallands Sjukhus, Varberg, Sweden

and more 177 locations

Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies

Phase 1

Completed

Conditions: Mantle Cell Lymphoma
B-Cell Lymphoma
Marginal Zone Lymphoma
Chronic Lymphocytic Lymphoma
Follicular Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Venetoclax
Drug: Magrolimab

First Posted Date: 2020-10-23

Last Posted Date: 2024-07-29

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT04599634

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

CC-486, Lenalidomide, and Obinutuzumab for the Treatment of Recurrent or Refractory CD20 Positive B-cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Refractory Lymphoplasmacytic Lymphoma
Recurrent Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Marginal Zone Lymphoma
Refractory Hairy Cell Leukemia
Refractory Marginal Zone Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia

Interventions: Drug: Lenalidomide
Biological: Obinutuzumab
Drug: Oral Azacitidine

First Posted Date: 2020-10-08

Last Posted Date: 2023-09-15

Lead Sponsor: Joseph Tuscano

Target Recruit Count: 8

Registration Number: NCT04578600

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Venetoclax
Drug: Obinutuzumab
Drug: Acalabrutinib

First Posted Date: 2020-09-23

Last Posted Date: 2024-05-08

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 40

Registration Number: NCT04560322

Locations: 🇺🇸
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas

Phase 1

Completed

Conditions: Uveal Melanoma
Mucosal Melanoma
Cutaneous Melanoma

Interventions: Drug: RO7293583
Drug: Tocilizumab
Drug: Obinutuzumab
Drug: Adalimumab

First Posted Date: 2020-09-16

Last Posted Date: 2022-10-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 20

Registration Number: NCT04551352

Locations: 🇧🇪
UZ Leuven Gasthuisberg, Leuven, Belgium
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

and more 11 locations

Sequential Regimen of Bendamustine Followed by Obinutuzumab (GA101), Zanubrutinib (BGB-3111) and Venetoclax (ABT-199) in Patients with Relapsed/refractory CLL

Phase 2

Active, not recruiting

Conditions: Chronic Lymphoid Leukemia

Interventions: Drug: Bendamustine
Biological: Obinutuzumab
Biological: Zanubrutinib
Biological: Venetoclax

First Posted Date: 2020-08-17

Last Posted Date: 2024-12-30

Lead Sponsor: German CLL Study Group

Target Recruit Count: 42

Registration Number: NCT04515238

Locations: 🇩🇪
Onkologische Schwerpunktpraxis, Esslingen, Germany
🇩🇪
Hamatologische/Onkologische Gemeinschaftspraxis, Augsburg, Germany
🇩🇪
Universitätsklinik Köln, Köln, Germany

and more 8 locations

A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas

Phase 1

Active, not recruiting

Conditions: Lymphoma

Interventions: Drug: CC-220
Drug: Rituximab
Drug: Obinutuzumab

First Posted Date: 2020-07-09

Last Posted Date: 2023-10-04

Lead Sponsor: Celgene

Target Recruit Count: 62

Registration Number: NCT04464798

Locations: 🇫🇷
Local Institution - 205, Pessac, France
🇰🇷
Local Institution - 501, Seoul, Korea, Republic of
🇺🇸
Local Institution - 105, Lake Mary, Florida, United States

and more 23 locations

The Combination of Venetoclax and Obinutuzumab in People With Chronic Lymphocytic Leukemia (CLL)

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia (CLL)

Interventions: Drug: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2020-06-25

Last Posted Date: 2025-01-08

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 100

Registration Number: NCT04447768

Locations: 🇺🇸
Stanford University Medical Center (Data collection only), Stanford, California, United States
🇺🇸
Memorial Sloan Kettering Monmouth (All protocol activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack (All protocol activities), Commack, New York, United States

and more 5 locations

A Safety and Preliminary Efficacy Study of CC-99282 in Combination With Obinutuzumab in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1

Completed

Conditions: Lymphoma, Non-Hodgkin

Interventions: Drug: CC-99282
Drug: Obinutuzumab

First Posted Date: 2020-06-16

Last Posted Date: 2024-07-25

Lead Sponsor: Celgene

Target Recruit Count: 16

Registration Number: NCT04434196

Locations: 🇺🇸
Local Institution - 104, Columbus, Ohio, United States
🇺🇸
Local Institution - 106, Boston, Massachusetts, United States
🇺🇸
Local Institution - 101, Portland, Oregon, United States

and more 12 locations

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 3

Active, not recruiting

Conditions: Diffuse Large B-cell Lymphoma

Interventions: Drug: Rituxumab
Drug: Obinutuzumab
Drug: Glofitamab
Drug: Tocilizumab
Drug: Gemcitabine
Drug: Oxaliplatin

First Posted Date: 2020-05-29

Last Posted Date: 2024-10-16

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 270

Registration Number: NCT04408638

Locations: 🇵🇱
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Terapii Komórkowych i Chorób Wewn?trznych, Wroc?aw, Poland
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Community Cancer Institute (CCI), Fresno, California, United States

and more 64 locations

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