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 Le...

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
-

A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

First Posted Date
2015-11-09
Last Posted Date
2023-12-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
114
Registration Number
NCT02600897
Locations
🇬🇧

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, United Kingdom

🇬🇧

Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone, United Kingdom

🇬🇧

Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital, Romford, United Kingdom

and more 25 locations

A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)

First Posted Date
2015-11-04
Last Posted Date
2021-05-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
91
Registration Number
NCT02596971
Locations
🇦🇺

Concord Repatriation General Hospital; Haematology, Sydney, New South Wales, Australia

🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute, Springfield, Oregon, United States

and more 18 locations

A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation

First Posted Date
2015-10-26
Last Posted Date
2020-01-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
24
Registration Number
NCT02586051
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

UCSF, San Francisco, California, United States

🇺🇸

Mayo Clinic - Minnesota, Rochester, Minnesota, United States

and more 6 locations

BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies

First Posted Date
2015-10-06
Last Posted Date
2024-10-26
Lead Sponsor
BeiGene
Target Recruit Count
119
Registration Number
NCT02569476
Locations
🇺🇸

Florida Cancer Specialists Fort Myers, Fort Myers, Florida, United States

🇺🇸

Florida Cancer Specialists East, West Palm Beach, Florida, United States

🇺🇸

Tennessee Oncology, Nashville, Tennessee, United States

and more 11 locations

A Study to Evaluate the Safety and Efficacy of Obinutuzumab Compared With Placebo in Participants With Lupus Nephritis (LN)

First Posted Date
2015-09-15
Last Posted Date
2024-08-27
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
126
Registration Number
NCT02550652
Locations
🇺🇸

Emory Uni ; Division of Rheumatology, Atlanta, Georgia, United States

🇺🇸

Univ of California, San Diego, La Jolla, California, United States

🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

and more 43 locations

A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2015-09-01
Last Posted Date
2024-07-30
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
54
Registration Number
NCT02537613
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

First Posted Date
2015-08-20
Last Posted Date
2022-11-03
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
59
Registration Number
NCT02529852
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL

First Posted Date
2015-06-19
Last Posted Date
2024-12-19
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
535
Registration Number
NCT02475681
Locations
🇬🇧

Research Site, Wolverhampton, United Kingdom

Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

First Posted Date
2015-05-29
Last Posted Date
2024-10-11
Lead Sponsor
Gilead Sciences
Target Recruit Count
203
Registration Number
NCT02457598
Locations
🇬🇧

Cardiff and Vale Health Board, Clinical Research Facility, Cardiff, United Kingdom

🇺🇸

Indiana University Health Goshen Center for Cancer Care, Goshen, Indiana, United States

🇺🇸

Georgetown University Medical Center, Washington, District of Columbia, United States

and more 12 locations

A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2015-05-25
Last Posted Date
2019-08-29
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
66
Registration Number
NCT02453087
Locations
🇺🇸

Stanford Cancer Center, Stanford, California, United States

🇺🇸

New York University Cancer Cen, New York, New York, United States

🇺🇸

Medical Center of Aurora; Rocky Mountain Cancer Centers, Aurora, Colorado, United States

and more 4 locations
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