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

A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome

Phase 3

Active, not recruiting

Conditions: Childhood Idiopathic Nephrotic Syndrome

Interventions: Drug: Obinutuzumab
Drug: MMF
Drug: Prednisone
Drug: Methylprednisolone
Drug: Acetaminophen/ Paracetamol
Drug: Diphenhydramine Hydrochloride

First Posted Date: 2022-11-25

Last Posted Date: 2025-04-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 80

Registration Number: NCT05627557

Locations: 🇫🇷
CHU de Nice, Nice, Alpes-Maritimes, France
🇺🇸
Cedars Sinai Medical Center, Los Angeles, California, United States
🇺🇸
Lucile Packard Children's Hospital - Stanford, Palo Alto, California, United States

and more 55 locations

Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)

Phase 2

Recruiting

Conditions: Leukemia

Interventions: Drug: Pirtobrutinib
Drug: Obinutuzumab
Drug: Venetoclax
Drug: Valacyclovir
Drug: Allopurinol

First Posted Date: 2022-09-10

Last Posted Date: 2025-04-08

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 60

Registration Number: NCT05536349

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

A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Mature B-Cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Mature B-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Glofitamab
Drug: Rituximab
Drug: Ifosfamide
Drug: Carboplatin
Drug: Etoposide
Drug: Tocilizumab

First Posted Date: 2022-09-09

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 65

Registration Number: NCT05533775

Locations: 🇧🇷
Graacc-Grupo de Apoio ao adolescente e a crianca com cancer, Sao Paulo, São Paulo, Brazil
🇩🇰
Rigshospitalet, København Ø, Denmark
🇫🇷
Hôpital Pellegrin, Bordeaux, France

and more 21 locations

A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden

Phase 2

Active, not recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Copanlisib
Drug: Obinutuzumab

First Posted Date: 2022-05-24

Last Posted Date: 2024-03-12

Lead Sponsor: Ludwig-Maximilians - University of Munich

Target Recruit Count: 98

Registration Number: NCT05387616

Locations: 🇩🇪
Carl-Thiem-Klinikum Cottbus gGmbH, Cottbus, Germany
🇩🇪
Universitätsklinikum Jena, Jena, Germany
🇩🇪
Charité Campus Benjamin Franklin, Berlin, Germany

and more 37 locations

PR3-AAV Resilient Remission or PRRR

Phase 2

Terminated

Conditions: Granulomatosis With Polyangiitis
ANCA Associated Vasculitis
Microscopic Polyangiitis

Interventions: Drug: Obinutuzumab
Drug: Rituximab

First Posted Date: 2022-05-17

Last Posted Date: 2024-07-31

Lead Sponsor: Mayo Clinic

Target Recruit Count: 6

Registration Number: NCT05376319

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic Rochester, Rochester, Minnesota, United States
🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions: Drug: Glofitamab
Drug: Obinutuzumab
Drug: Tocilizumab
Drug: Rituximab
Drug: Ifosfamide
Drug: Carboplatin
Drug: Etoposide

First Posted Date: 2022-05-06

Last Posted Date: 2025-03-18

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 43

Registration Number: NCT05364424

Locations: 🇺🇸
Tulane Medical Center, New Orleans, Louisiana, United States
🇺🇸
Chao Family Comprehensive Cancer Center UCI, Orange, California, United States
🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 6 locations

Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Acalabrutinib
Biological: Obinutuzumab
Drug: Venetoclax

First Posted Date: 2022-04-20

Last Posted Date: 2024-03-15

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Target Recruit Count: 52

Registration Number: NCT05336812

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Zanubrutinib in Patients With Waldenström's Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma and Follicular Lymphoma

Recruiting

Conditions: Marginal Zone Lymphoma
Waldenström's Macroglobulinemia
Follicular Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Drug: Zanubrutinib
Drug: Obinutuzumab

First Posted Date: 2022-04-13

Last Posted Date: 2024-10-01

Lead Sponsor: iOMEDICO AG

Target Recruit Count: 605

Registration Number: NCT05326308

Locations: 🇩🇪
Lübecker Onkologische Schwerpunktpraxis, Lübeck, Schleswig-Holstein, Germany
🇦🇹
Universitätsklinikum Salzburg, Klinik für Innere Medizin III, Salzburg, Austria

Orelabrutinib and Obinutuzumab Plus FC Regimen in Treating Newly Diagnosed CLL/SLL

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions: Drug: Orelabrutinib
Drug: Obinutuzumab
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2022-04-12

Last Posted Date: 2022-04-19

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 25

Registration Number: NCT05322733

Locations: 🇨🇳
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjin, Jiangsu, China

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Phase 1

Terminated

Conditions: Lymphoma, Non-Hodgkin

Interventions: Drug: RO7443904
Drug: Glofitamab
Drug: Obinutuzumab
Drug: Tocilizumab

First Posted Date: 2022-02-02

Last Posted Date: 2024-08-23

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 53

Registration Number: NCT05219513

Locations: 🇫🇷
CHRU Lille - Hôpital Claude Huriez; Service des Maladies du Sang, Lille, France
🇮🇹
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
🇮🇹
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy

and more 6 locations

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