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

Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Biological: Obinutuzumab
Biological: Glofitamab
Drug: Pirtobrutinib
Procedure: Tumor Imaging
Procedure: Biospecimen Collection
Device: ClonoSeq Assay
Procedure: Bone Marrow Biopsy

First Posted Date: 2024-02-12

Last Posted Date: 2025-05-07

Lead Sponsor: C. Babis Andreadis

Target Recruit Count: 30

Registration Number: NCT06252675

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

A Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

Phase 2

Recruiting

Conditions: B Cell Lymphoma

Interventions: Drug: Glofitamab
Drug: Obinutuzumab
Drug: Axi-cel

First Posted Date: 2024-01-19

Last Posted Date: 2025-02-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT06213311

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

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Phase 3

Recruiting

Conditions: Follicular Lymphoma (FL)

Interventions: Drug: Epcoritamab
Drug: Prednisone
Drug: Rituximab
Drug: Lenalidomide
Drug: Doxorubicin
Drug: Vincristine
Drug: Bendamustine
Drug: Cyclophosphamide
Drug: Obinutuzumab

First Posted Date: 2024-01-05

Last Posted Date: 2025-04-30

Lead Sponsor: Genmab

Target Recruit Count: 1095

Registration Number: NCT06191744

Locations: 🇫🇷
Hôpital Saint-Louis /ID# 260509, Paris, France
🇫🇷
Clinique Sainte-Anne /ID# 261528, Strasbourg, France
🇨🇳
Zhujiang Hospital of Southern Medical University /ID# 260558, Guangzhou, Guangdong, China

and more 217 locations

A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma

Phase 1

Recruiting

Conditions: Mantle Cell Lymphoma
MCL

Interventions: Drug: Glofitamab
Drug: Obinutuzumab
Drug: Lenalidomide

First Posted Date: 2024-01-05

Last Posted Date: 2025-05-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 39

Registration Number: NCT06192888

Locations: 🇺🇸
Dana Farber Cancer Institute (Data Collection and Specimen Analysis), Boston, Massachusetts, United States
🇺🇸
Mayo Clinic (Data Collection Only), Rochester, Minnesota, United States
🇺🇸
Washington University (Data Collection Only), Saint Louis, Missouri, United States

and more 7 locations

Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

Phase 2

Recruiting

Conditions: Primary Central Nervous System Lymphoma

Interventions: Procedure: Cognitive Assessment
Biological: Obinutuzumab
Other: Quality of Life Assessment

First Posted Date: 2023-12-18

Last Posted Date: 2025-04-15

Lead Sponsor: Providence Health & Services

Target Recruit Count: 28

Registration Number: NCT06175000

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Providence Health & Services; Providence Neurological Specialties, Portland, Oregon, United States

and more 4 locations

REmission in Membranous Nephropathy International Trial (REMIT)

Phase 3

Not yet recruiting

Conditions: Primary Membranous Nephropathy

Interventions: Drug: Oral prednisolone and cyclophosphamide
Drug: Obinutuzumab

First Posted Date: 2023-11-07

Last Posted Date: 2023-11-07

Lead Sponsor: The University of Queensland

Target Recruit Count: 224

Registration Number: NCT06120673

Locations: 🇦🇺
Royal Brisbane and Women's Hospital, Brisbane, Queensland, Australia
🇦🇺
Cairns Hospital, Cairns, Queensland, Australia
🇦🇺
Fiona Stanley Hospital, Murdoch, Western Australia, Australia

and more 10 locations

Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma

Phase 2

Recruiting

Conditions: Follicular Lymphoma
Tumor

Interventions: Drug: Obinutuzumab
Drug: CC-99282

First Posted Date: 2023-10-30

Last Posted Date: 2025-04-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 36

Registration Number: NCT06108232

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

A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Pediatric Primary Immune Thrombocytopenia (ITP)

Phase 2

Recruiting

Conditions: Treatment
Immune Thrombocytopenia

Interventions: Drug: Obinutuzumab Injection [Gazyva]

First Posted Date: 2023-10-23

Last Posted Date: 2025-02-24

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

Target Recruit Count: 60

Registration Number: NCT06094881

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

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

Phase 3

Recruiting

Conditions: Lymphoma

Interventions: Drug: Rituximab
Drug: Obinutuzumab
Drug: Glofitamab
Drug: Bendamustine
Drug: Tocilizumab
Drug: Lenalidomide

First Posted Date: 2023-10-16

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 182

Registration Number: NCT06084936

Locations: 🇫🇷
CHU NANTES - Hôtel Dieu, Nantes, France
🇧🇷
ICTR Curitiba, Curitiba, Paraná, Brazil
🇨🇳
Chongqing Cancer Hospital, Chongqing, China

and more 71 locations

A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma

Phase 2

Recruiting

Conditions: Large B-cell Lymphoma

Interventions: Drug: Glofitamab
Drug: Polatuzumab vedotin
Drug: Obinutuzumab

First Posted Date: 2023-10-10

Last Posted Date: 2024-12-24

Lead Sponsor: University College, London

Target Recruit Count: 99

Registration Number: NCT06071871

Locations: 🇬🇧
Kings College Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧
University College London Hospitals NHS Foundation Trust, London, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, United Kingdom

and more 2 locations

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