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
Obinutuzumab in Combination With GDP Chemotherapy in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- Conditions
- Lymphoma, Non-Hodgkin's
- Interventions
- First Posted Date
- 2016-04-25
- Last Posted Date
- 2021-04-13
- Lead Sponsor
- University Health Network, Toronto
- Target Recruit Count
- 30
- Registration Number
- NCT02750670
- Locations
- 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
A Study Evaluating Safety and Efficacy of Obinutuzumab, Polatuzumab Vedotin (Pola), and Atezolizumab (Atezo) in Participants With Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab, Atezo, and Pola in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Lymphoma
- Interventions
- First Posted Date
- 2016-04-06
- Last Posted Date
- 2020-12-23
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 36
- Registration Number
- NCT02729896
- Locations
- 🇵🇱
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw, Poland
🇺🇸UCLA, Los Angeles, California, United States
🇺🇸University Miami, Miami, Florida, United States
Combination of PCI-32765 With Obinutuzumab in Untreated Follicular Lymphoma
- First Posted Date
- 2016-02-24
- Last Posted Date
- 2021-05-07
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Target Recruit Count
- 98
- Registration Number
- NCT02689869
- Locations
- 🇩🇪
Klinikum der Universität München, München, Bavaria, Germany
Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.
- First Posted Date
- 2016-02-01
- Last Posted Date
- 2017-03-20
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Target Recruit Count
- 1
- Registration Number
- NCT02670317
- Locations
- 🇮🇹
IRCCS Napoli Pascale, Napoli, Italy
🇮🇹Ospedale San Gerardo, Monza, Italy
🇮🇹Ospedale Maggiore della Carità, Novara, Italy
Phase II Trial GA101 Inbrutinib B CLL
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- First Posted Date
- 2016-01-28
- Last Posted Date
- 2025-03-18
- Lead Sponsor
- French Innovative Leukemia Organisation
- Target Recruit Count
- 135
- Registration Number
- NCT02666898
- Locations
- 🇫🇷
Sponsor FILO, Tours, France
A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
- Conditions
- Lymphoma, Follicular
- Interventions
- First Posted Date
- 2015-12-16
- Last Posted Date
- 2022-04-13
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 38
- Registration Number
- NCT02631577
- Locations
- 🇺🇸
University Miami, Miami, Florida, United States
🇫🇷Hopital du Bocage, Dijon, France
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
Ibrutinib, Fludarabine Phosphate, Cyclophosphamide, and Obinutuzumab in Treating Patients With Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- First Posted Date
- 2015-12-14
- Last Posted Date
- 2025-03-19
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 81
- Registration Number
- NCT02629809
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- First Posted Date
- 2015-12-09
- Last Posted Date
- 2020-05-18
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 25
- Registration Number
- NCT02624986
- Locations
- 🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States
🇩🇪Charité Research Organisation GmbH Campus-Virchow-Klinikum, Berlin, Germany
🇰🇷Samsung Medical Center, Seoul, Korea, Republic of
Obinutuzumab With High-dose Ibrutinib for the Treatment of Patients With Chronic Lymphocytic Leukemia With Progressive Disease on Single Agent Ibrutinib.
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2015-11-23
- Last Posted Date
- 2019-01-25
- Lead Sponsor
- Michael Choi
- Registration Number
- NCT02611908
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2015-11-23
- Last Posted Date
- 2024-12-13
- Lead Sponsor
- TG Therapeutics, Inc.
- Target Recruit Count
- 603
- Registration Number
- NCT02612311
- Locations
- 🇬🇧
TG Therapeutics Investigational Trial Site, Wolverhampton, United Kingdom
Drug Development Updates
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