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

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System

Phase 1

Active, not recruiting

Conditions: Primary Diffuse Large B-cell Lymphoma of the Central Nervous System (CNS)
Aggressive B-cell Lymphoma With Secondary Involvement of the CNS

Interventions: Drug: Obinutuzumab
Drug: Prednisone
Drug: Lenalidomide
Drug: Venetoclax
Drug: Ibrutinib
Drug: Acetaminophen
Drug: Diphenhydramine
Other: Peg-filgrastim
Diagnostic Test: CT Scan (chest, abdomen, and pelvis)
Diagnostic Test: MRI
Diagnostic Test: 18f-FDG-PET
Diagnostic Test: PET
Diagnostic Test: Lumbar puncture/Ommaya tap
Diagnostic Test: Bone marrow aspiration/biopsy
Combination Product: EKG

First Posted Date: 2022-01-27

Last Posted Date: 2025-04-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 14

Registration Number: NCT05211336

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

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients with High Risk CLL

Phase 3

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Obinutuzumab
Drug: Venetoclax
Drug: Acalabrutinib

First Posted Date: 2022-01-19

Last Posted Date: 2024-12-30

Lead Sponsor: German CLL Study Group

Target Recruit Count: 650

Registration Number: NCT05197192

Locations: 🇩🇪
Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany
🇩🇪
DRK Kliniken Berlin Köpenick, Berlin, Germany
🇩🇪
Helios Klinikum Bad Saarow, Bad Saarow, Germany

and more 27 locations

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Non-Hodgkin Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Indolent B-Cell Non-Hodgkin Lymphoma
Marginal Zone Lymphoma
Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Interventions: Biological: Mosunetuzumab
Biological: Obinutuzumab
Drug: Polatuzumab Vedotin
Procedure: FDG-Positron Emission Tomography
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Biospecimen Collection

First Posted Date: 2021-12-27

Last Posted Date: 2025-04-11

Lead Sponsor: University of Washington

Target Recruit Count: 42

Registration Number: NCT05169658

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: SC Mosunetuzumab
Drug: IV Glofitamab
Drug: Iberdomide
Drug: Golcadomide
Drug: Obinutuzumab
Drug: Tocilizumab

First Posted Date: 2021-12-27

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 121

Registration Number: NCT05169515

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇮🇱
Sourasky Medical Center, Tel-Aviv, Israel

and more 23 locations

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax in Combination With Intravenous (IV) Obinutuzumab or Oral Ibrutinib in Adult Participants With Untreated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)

Interventions: Drug: Venetoclax
Drug: Obinutuzumab
Drug: Ibrutinib

First Posted Date: 2021-11-03

Last Posted Date: 2024-06-18

Lead Sponsor: AbbVie

Target Recruit Count: 20

Registration Number: NCT05105841

Locations: 🇯🇵
National Cancer Center Hospital /ID# 232449, Chuo-ku, Tokyo, Japan
🇯🇵
University Hospital Kyoto Prefectural University of Medicine /ID# 239883, Kyoto-shi, Kyoto, Japan
🇯🇵
Tohoku University Hospital /ID# 238433, Sendai-shi, Miyagi, Japan

and more 17 locations

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Phase 3

Recruiting

Conditions: Relapsed/Refractory Follicular Lymphoma
Marginal Zone Lymphoma

Interventions: Drug: Zanubrutinib
Drug: Rituximab
Drug: Obinutuzumab
Drug: Lenalidomide

First Posted Date: 2021-10-29

Last Posted Date: 2025-05-01

Lead Sponsor: BeiGene

Target Recruit Count: 780

Registration Number: NCT05100862

Locations: 🇩🇪
Universitaetsklinikum Ulm, Ulm, Germany
🇹🇷
Ondokuz Mayis University Medicine Faculty Hospital, Atakum Samsun, Turkey
🇹🇷
Dokuz Eylul University, Balcova, Turkey

and more 288 locations

A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Venetoclax
Drug: Obinutuzumab

First Posted Date: 2021-09-27

Last Posted Date: 2025-03-04

Lead Sponsor: AstraZeneca

Target Recruit Count: 607

Registration Number: NCT05057494

Locations: 🇪🇸
Research Site, Palma de Mallorca, Spain

Obinutuzumab in Primary MN

Phase 2

Active, not recruiting

Conditions: Membranous Nephropathy

Interventions: Drug: Obinutuzumab

First Posted Date: 2021-09-20

Last Posted Date: 2025-05-09

Lead Sponsor: Mario Negri Institute for Pharmacological Research

Target Recruit Count: 20

Registration Number: NCT05050214

Locations: 🇮🇹
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica, BG, Italy
🇮🇹
ASST HPG23 - Unità di Nefrologia, Bergamo, BG, Italy

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants

Phase 2

Recruiting

Conditions: Lupus Nephritis

Interventions: Drug: Placebo
Drug: Obinutuzumab
Drug: Mycophenolate Mofetil
Drug: Acetaminophen/paracetamol
Drug: Diphenhydramine hydrochloride (HCl)
Drug: Methylprednisolone
Drug: Prednisone

First Posted Date: 2021-09-09

Last Posted Date: 2025-04-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 40

Registration Number: NCT05039619

Locations: 🇿🇦
Panaroma Medical Center, Panorama, South Africa
🇺🇸
Loma Linda University health, Loma Linda, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 39 locations

Obinutuzumab in Primary FSGS

Phase 2

Active, not recruiting

Conditions: Primary Focal Segmental Glomerulosclerosis

Interventions: Drug: Obinutuzumab

First Posted Date: 2021-07-30

Last Posted Date: 2025-01-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT04983888

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

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