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 Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

Phase 2

Not yet recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Obinutuzumab
Drug: Glofitamab
Drug: Bortezomib
Drug: Orelabrutinib

First Posted Date: 2024-10-24

Last Posted Date: 2024-11-19

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 29

Registration Number: NCT06656221

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

Phase 2

Not yet recruiting

Conditions: Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Refractory Diffuse Large B-Cell Lymphoma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Ibrutinib
Drug: Lenalidomide
Procedure: Magnetic Resonance Imaging
Biological: Obinutuzumab
Procedure: Positron Emission Tomography
Drug: Prednisone
Drug: Venetoclax

First Posted Date: 2024-10-21

Last Posted Date: 2025-05-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 120

Registration Number: NCT06649812

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Phase 1

Recruiting

Conditions: B-cell Malignancy
Relapsed Cancer
Refractory Cancer
B-cell Lymphoma

Interventions: Drug: BGB-16673
Drug: Sonrotoclax
Drug: Zanubrutinib
Drug: Mosunetuzumab
Drug: Glofitamab
Drug: Obinutuzumab

First Posted Date: 2024-10-10

Last Posted Date: 2025-05-09

Lead Sponsor: BeiGene

Target Recruit Count: 80

Registration Number: NCT06634589

Locations: 🇮🇹
Centroricerche Cliniche Di Verona Srl, Verona, Italy
🇺🇸
Mayo Clinic Phoenix, Phoenix, Arizona, United States
🇺🇸
University of Southern Californianorris Comprehensive, Los Angeles, California, United States

and more 42 locations

A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Recruiting

Conditions: Lymphoma

Interventions: Drug: Glofitamab
Drug: Tocilizumab
Drug: Obinutuzumab
Drug: Gemcitabine
Drug: Oxaliplatin

First Posted Date: 2024-10-02

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 50

Registration Number: NCT06624085

Locations: 🇺🇸
University of California Los Angeles (UCLA) - Cancer Care - Santa Monica, Santa Monica, California, United States
🇺🇸
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 5 locations

CAR T-cell Therapy in Combination With Glofitamab for Relapsed/Refractory Large B-Cell Lymphoma With High-Risk Prognostic Factors

Phase 2

Not yet recruiting

Conditions: Large B-cell Lymphoma

Interventions: Biological: CAR T-cell therapy
Drug: Glofitamab
Drug: Obinutuzumab

First Posted Date: 2024-08-22

Last Posted Date: 2024-08-22

Lead Sponsor: Ruijin Hospital

Target Recruit Count: 45

Registration Number: NCT06567366

Locations: 🇨🇳
Shanghai Ruijin Hospital, Shanghai, China

Oxygen Study-Orelabrutinib Combined With Obinutuzumab(O2) for First-Line Treatment of Marginal Zone Lymphoma

Phase 2

Recruiting

Conditions: Marginal Zone Lymphoma

Interventions: Drug: Orelabrutinib, obinutuzumab

First Posted Date: 2024-08-22

Last Posted Date: 2024-08-22

Lead Sponsor: Huai'an First People's Hospital

Target Recruit Count: 51

Registration Number: NCT06566807

Locations: 🇨🇳
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University#Huai'an First People's Hospital#, Huai'an,, Jiangsu, China

A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People with Hairy Cell Leukemia (HCL)

Phase 2

Recruiting

Conditions: Hairy Cell Leukemia

Interventions: Drug: Vemurafenib
Drug: Cladribine
Drug: Obinutuzumab
Drug: Rituximab

First Posted Date: 2024-08-20

Last Posted Date: 2024-10-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 86

Registration Number: NCT06561360

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
🇺🇸
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 7 locations

A Phase II Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma

Phase 2

Recruiting

Conditions: Lymphoma, Mantle-Cell

Interventions: Drug: Obinutuzumab
Drug: Glofitamab
Drug: Venetoclax Oral Product
Drug: Zanubrutinib Oral Capsule

First Posted Date: 2024-08-16

Last Posted Date: 2025-01-27

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 100

Registration Number: NCT06558604

Locations: 🇧🇪
Az Sint-Jan Brugge - Oostende Av, Brugge, Belgium
🇧🇪
Institut Jules Bordet, Brussel, Belgium
🇧🇪
Chu de Liege, Liège, Belgium

and more 14 locations

Zanubrutinib With Obinutuzumab in Untreated Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Zanubrutinib Oral Product
Drug: Obinutuzumab

First Posted Date: 2024-08-09

Last Posted Date: 2024-10-24

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 106

Registration Number: NCT06544785

Locations: 🇪🇸
H. Vall d'Hebron, Barcelona, Spain

Zanubrutinib, Obinutuzumab and Lenalidomide in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Phase 1

Active, not recruiting

Conditions: Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia
Newly Diagnosed

Interventions: Drug: Zanubrutinib
Drug: Lenalidomide
Drug: Obinutuzumab

First Posted Date: 2024-08-09

Last Posted Date: 2024-08-09

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

Target Recruit Count: 30

Registration Number: NCT06547944

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

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