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

Safe Accelerated Venetoclax Escalation in CLL

Phase 1

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Venetoclax
Drug: Obinutuzumab
Drug: Rituximab

First Posted Date: 2021-04-14

Last Posted Date: 2024-06-04

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 40

Registration Number: NCT04843904

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment

Phase 1

Completed

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: RO7122290
Drug: Cibisatamab
Drug: Obinutuzumab

First Posted Date: 2021-04-01

Last Posted Date: 2025-01-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 54

Registration Number: NCT04826003

Locations: 🇩🇰
Rigshospitalet, København Ø, Denmark
🇪🇸
Clinica Universitaria de Navarra, Pamplona, Navarra, Spain
🇪🇸
Hospital del Mar, Barcelona, Spain

and more 9 locations

To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302)

Phase 3

Withdrawn

Conditions: Follicular Lymphoma ( FL)
Marginal Zone Lymphoma (MZL)

Interventions: Drug: rituximab
Drug: parsaclisib
Drug: obinutuzumab

First Posted Date: 2021-03-15

Last Posted Date: 2022-07-18

Lead Sponsor: Incyte Corporation

Registration Number: NCT04796922

Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma

Phase 1

Recruiting

Conditions: Lymphoma
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Burkitt Lymphoma

Interventions: Biological: obinutuzumab
Drug: prednisone
Drug: Revlimid
Biological: Polatuzumab
Drug: ibrutinib
Drug: venetoclax

First Posted Date: 2021-02-05

Last Posted Date: 2024-12-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT04739813

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

A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma

Phase 1

Terminated

Conditions: Follicular Lymphoma

Interventions: Drug: Venetoclax
Drug: Obinutuzumab
Drug: CC-486

First Posted Date: 2021-01-25

Last Posted Date: 2024-05-16

Lead Sponsor: University of Chicago

Target Recruit Count: 2

Registration Number: NCT04722601

Locations: 🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

A Study on Limiting Treatment Time With Acalabrutinib Combined With Obinutuzumab in People With CLL or SLL

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Acalabrutinib
Drug: Obinutuzumab

First Posted Date: 2021-01-25

Last Posted Date: 2025-01-09

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 55

Registration Number: NCT04722172

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (All protocol activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester (All protocol activities), Harrison, New York, United States

and more 5 locations

Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

Phase 2

Active, not recruiting

Conditions: Refractory Primary Mediastinal Large B-Cell Cell Lymphoma
Refractory Mantle Cell Lymphoma
Refractory Transformed B-cell Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma Refractory
Refractory Indolent Adult Non-Hodgkin Lymphoma

Interventions: Drug: Obinutuzumab
Drug: RO7082859

First Posted Date: 2021-01-11

Last Posted Date: 2023-12-05

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 67

Registration Number: NCT04703686

Locations: 🇫🇷
CHU Montpellier, Montpellier, France
🇫🇷
CHU Nantes, Nantes, France
🇫🇷
CHU de Bordeaux - Hôpital Haut Leveque, Pessac, France

and more 12 locations

Induction Therapy for Lupus Nephritis With no Added Oral Steroids: A Trial Comparing Oral Corticosteroids Plus Mycophenolate Mofetil (MMF) Versus Obinutuzumab and MMF

Phase 3

Recruiting

Conditions: Lupus Nephritis
Systemic Lupus Erythematosus (SLE)

Interventions: Drug: Obinutuzumab administration
Drug: Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil
Drug: Administration of methylprednisolone, paracetamol and dexchlorpheniramine

First Posted Date: 2021-01-08

Last Posted Date: 2023-03-16

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 196

Registration Number: NCT04702256

Locations: 🇫🇷
Internal medicine, Cochin hospital, APHP, Paris, France

A Study to Evaluate Glofitamab as Single Agent Administered After Pretreatment With Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Glofitamab
Drug: Tocilizumab

First Posted Date: 2020-12-08

Last Posted Date: 2024-01-19

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 30

Registration Number: NCT04657302

Locations: 🇨🇳
Tianjin Cancer Hospital, Tianjin, China
🇨🇳
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology, Guangzhou City, China
🇨🇳
Beijing Cancer Hospital, Beijing, China

and more 3 locations

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

Phase 3

Active, not recruiting

Conditions: Primary Membranous Nephropathy

Interventions: Drug: Obinutuzumab
Drug: Tacrolimus
Drug: Methylprednisolone
Drug: Acetaminophen
Drug: Diphenhydramine

First Posted Date: 2020-11-16

Last Posted Date: 2024-12-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 142

Registration Number: NCT04629248

Locations: 🇺🇦
Regional Clinical Hospital n.a I.I. Mechnicov, Dnipropetrovsk, Ukraine
🇺🇦
Ternopil University Hospital, Ternopil, Kherson Governorate, Ukraine
🇺🇸
Nephrotex Research Group, Dallas, Texas, United States

and more 52 locations

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