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

Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Zanubrutinib
Drug: Lenalidomide
Drug: Cytarabine
Biological: CAR-T

First Posted Date: 2024-07-16

Last Posted Date: 2024-08-09

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 39

Registration Number: NCT06504199

Locations: 🇨🇳
Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China
🇨🇳
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin, China

Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

Phase 2

Not yet recruiting

Conditions: FL

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

First Posted Date: 2024-06-25

Last Posted Date: 2024-06-25

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Target Recruit Count: 30

Registration Number: NCT06474481

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Phase 3

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Venetoclax
Drug: Acalabrutinib
Drug: Obinutuzumab

First Posted Date: 2024-05-24

Last Posted Date: 2025-05-04

Lead Sponsor: AbbVie

Target Recruit Count: 120

Registration Number: NCT06428019

Locations: 🇺🇸
West Virginia University School of Medicine /ID# 267645, Morgantown, West Virginia, United States
🇺🇸
Arizona Oncology - Tucson - Rudasill /ID# 267552, Tucson, Arizona, United States
🇺🇸
UCSF FRESNO/Community Cancer Institute /ID# 270874, Clovis, California, United States

and more 61 locations

Obinutuzumab Combined With Bendamustine in the Treatment of Mature B-cell Lymphoma

Phase 2

Recruiting

Conditions: B Cell Lymphoma

Interventions: Drug: Obinutuzumab Combined With Bendamustine

First Posted Date: 2024-05-16

Last Posted Date: 2024-05-16

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 134

Registration Number: NCT06415708

Locations: 🇨🇳
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin, Tianjin, China

Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma

Phase 1

Not yet recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: FDG-Positron Emission Tomography
Biological: Glofitamab
Drug: Ibrutinib
Procedure: Magnetic Resonance Imaging
Biological: Obinutuzumab

First Posted Date: 2024-04-10

Last Posted Date: 2025-04-20

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 27

Registration Number: NCT06357676

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Pirtobrutinib
Drug: Obinutuzumab

First Posted Date: 2024-03-27

Last Posted Date: 2024-07-10

Lead Sponsor: Inhye Ahn

Target Recruit Count: 60

Registration Number: NCT06333262

Locations: 🇺🇸
Brigham & Women's Hospital, Boston, Massachusetts, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 1 locations

Obinutuzumab in Treatment of Fibrillary Glomerulonephritis

Phase 2

Recruiting

Conditions: Fibrillary Glomerulonephritis

Interventions: Drug: Obinutuzumab

First Posted Date: 2024-03-06

Last Posted Date: 2025-04-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT06295770

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

A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Phase 1

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Obinutuzumab
Drug: ABBV-453

First Posted Date: 2024-03-04

Last Posted Date: 2025-05-14

Lead Sponsor: AbbVie

Target Recruit Count: 80

Registration Number: NCT06291220

Locations: 🇩🇪
Universitaetsklinikum Ulm /ID# 263148, Ulm, Baden-Wuerttemberg, Germany
🇺🇸
City of Hope /ID# 253904, Duarte, California, United States
🇺🇸
City of Hope Orange County Lennar Foundation Cancer Center /ID# 267158, Irvine, California, United States

and more 18 locations

Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5

Phase 3

Recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Mosunetuzumab
Drug: Rituximab
Drug: Obinutuzumab
Drug: Bendamustin
Drug: Cyclophosphamide
Drug: Lenalidomide
Drug: Doxorubicin
Drug: Vincristin
Drug: Prednisone

First Posted Date: 2024-02-28

Last Posted Date: 2024-10-11

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 790

Registration Number: NCT06284122

Locations: 🇫🇷
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes, Créteil, France
🇫🇷
GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique, Villejuif, France
🇫🇷
CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie, Pringy, France

and more 46 locations

AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus

Phase 1

Recruiting

Conditions: Lupus Nephritis - WHO Class III
Refractory Systemic Lupus Erythematosus
Lupus Nephritis - WHO Class IV

Interventions: Drug: AB-101
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Rituximab
Drug: Obinutuzumab

First Posted Date: 2024-02-20

Last Posted Date: 2024-07-12

Lead Sponsor: Artiva Biotherapeutics, Inc.

Target Recruit Count: 51

Registration Number: NCT06265220

Locations: 🇺🇸
University of Alabama at Birmingham (UAB), Birmingham, Alabama, United States
🇺🇸
University of California, San Diego, San Diego, California, United States

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