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
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2015-06-19
- Last Posted Date
- 2025-03-11
- 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
- Conditions
- B-cell Malignancies
- Interventions
- 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
A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- 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
Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)
- Conditions
- Chronic Lymphocytic Leucemia
- Interventions
- First Posted Date
- 2015-05-15
- Last Posted Date
- 2024-05-09
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 48
- Registration Number
- NCT02445131
- Locations
- 🇩🇪
German CLL Study Group, Cologne, Germany
A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
- Conditions
- Lymphoma, Large B-Cell, DiffuseLymphoma, Non-Hodgkin
- Interventions
- First Posted Date
- 2015-04-15
- Last Posted Date
- 2023-10-23
- Lead Sponsor
- Celgene
- Target Recruit Count
- 75
- Registration Number
- NCT02417285
- Locations
- 🇳🇱
Local Institution - 201, Amsterdam, Netherlands
🇳🇱Local Institution - 202, Rotterdam, Netherlands
🇫🇷Local Institution - 105, Borddeaux Cedex, France
A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- First Posted Date
- 2015-04-02
- Last Posted Date
- 2021-09-20
- Lead Sponsor
- Celgene
- Target Recruit Count
- 47
- Registration Number
- NCT02406742
- Locations
- 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇦🇹University Hospital of Salzburg St Johanns Spital, Salzburg, Austria
🇺🇸The West Clinic, Memphis, Tennessee, United States
Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)
- Conditions
- Chronic Lymphocytic Leucemia
- Interventions
- First Posted Date
- 2015-03-27
- Last Posted Date
- 2024-12-30
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 66
- Registration Number
- NCT02401503
- Locations
- 🇩🇪
German CLL Study Group, Cologne, Germany
Obinutuzumab and ICE Chemotherapy in Refractory/Recurrent CD20+ Mature NHL
- Conditions
- Non-Hodgkin LymphomaBurkitt LymphomaDiffuse Large B-Cell LymphomaPrimary Mediastinal B-cell LymphomaCD20+ Lymphoblastic LymphomaFollicular Lymphoma, Grade III
- Interventions
- First Posted Date
- 2015-03-19
- Last Posted Date
- 2023-10-26
- Lead Sponsor
- New York Medical College
- Target Recruit Count
- 25
- Registration Number
- NCT02393157
- Locations
- 🇺🇸
New York Medical College, Valhalla, New York, United States
A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)
- Conditions
- CD20+ Follicular Lymphoma
- Interventions
- First Posted Date
- 2015-03-18
- Last Posted Date
- 2023-09-28
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 55
- Registration Number
- NCT02391545
Lenalidomide and Obinutuzumab for Previously Untreated CLL
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2015-02-25
- Last Posted Date
- 2018-02-23
- Lead Sponsor
- University of California, San Diego
- Registration Number
- NCT02371590
- Locations
- 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
Drug Development Updates
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