Ofatumumab
- Generic Name
- Ofatumumab
- Brand Names
- Arzerra, Kesimpta
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 679818-59-8
- Unique Ingredient Identifier
- M95KG522R0
- Background
Ofatumumab is a novel anti-CD20 monoclonal antibody that targets B-cells. It is an IgG1κ human monoclonal antibody produced from a recombinant murine cell line (NS0) via transgenic mouse and hybridoma technology. Ofatumumab works by recognizing antigens that are expressed on the tumour cells in certain cancers; however, the antigen is not tumour-specific and...
- Indication
Ofatumumab is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
...
- Associated Conditions
- Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia (CLL) - Refractory, Clinically Isolated Syndrome (CIS), Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS), Progressive Chronic Lymphocytic Leukaemia (CLL), Recurrent Chronic Lymphocytic Leukaemia (CLL)
- Associated Therapies
- -
A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)
- Conditions
- Interventions
- First Posted Date
- 2012-04-18
- Last Posted Date
- 2017-02-23
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 44
- Registration Number
- NCT01580228
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2012-04-17
- Last Posted Date
- 2019-12-18
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 391
- Registration Number
- NCT01578707
- Locations
- 🇺🇸
Site # 059, New Brunswick, New Jersey, United States
🇦🇺Site # 501, Fitzroy, Victoria, Australia
🇺🇸Site #408, La Jolla, California, United States
Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2012-03-15
- Last Posted Date
- 2022-06-29
- Lead Sponsor
- C. Babis Andreadis
- Target Recruit Count
- 19
- Registration Number
- NCT01555541
- Locations
- 🇺🇸
University of California, San Francisco, San Francisco, California, United States
Ofatumumab/Methylprednisolone and Ofatumumab/Lenalidomide for Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Conditions
- Interventions
- First Posted Date
- 2011-12-22
- Last Posted Date
- 2021-04-27
- Target Recruit Count
- 29
- Registration Number
- NCT01497496
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Ofatumumab, High Dose Methylprednisolone, Ofatumumab and Lenalidomide Consolidative Therapy for Untreated CLL/SLL
- Conditions
- Interventions
- First Posted Date
- 2011-12-22
- Last Posted Date
- 2024-11-29
- Target Recruit Count
- 45
- Registration Number
- NCT01496976
- Locations
- 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Ofatumumab With IVAC Salvage Chemotherapy in Diffuse Large B Cell Lymphoma Patients
- First Posted Date
- 2011-11-29
- Last Posted Date
- 2021-12-27
- Lead Sponsor
- Polish Lymphoma Research Group
- Target Recruit Count
- 77
- Registration Number
- NCT01481272
- Locations
- 🇵🇱
Instytut Hematologii i Transfuzjologii, Warszawa, Mazowieckie, Poland
🇵🇱Dolnośląskie Centrum Transplantacji Komórkowych, Wrocław, Dolnośląskie, Poland
🇵🇱Uniwersyteckie Cenrum Medyczne, Gdańsk, Pomorskie, Poland
Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL
- Conditions
- Interventions
- First Posted Date
- 2011-11-04
- Last Posted Date
- 2023-08-29
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 30
- Registration Number
- NCT01465334
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Phase I/II Study of Bendamustine in Combination With Ofatumumab, Carboplatin and Etoposide
- First Posted Date
- 2011-10-24
- Last Posted Date
- 2023-12-19
- Target Recruit Count
- 38
- Registration Number
- NCT01458366
- Locations
- 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Ofatumumab as Part of Reduced Intensity Conditioning (RIC) Regimen for Patients With High Risk Chronic Lymphocytic Leukemia (CLL) Undergoing Allogeneic Hematopoietic Cell Transplantation
- First Posted Date
- 2011-10-19
- Last Posted Date
- 2022-05-06
- Target Recruit Count
- 25
- Registration Number
- NCT01455051
- Locations
- 🇪🇸
Hospital de la Santa Creu Sant Pau, Barcelona, Spain
🇪🇸Hospital Germans Trias i Pujol, Badalona, Spain
🇪🇸Hospital La Princesa, Madrid, Spain
Phase IV Observational Study in Chronic Lymphocytic Leukemia
- First Posted Date
- 2011-10-17
- Last Posted Date
- 2014-07-08
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1
- Registration Number
- NCT01453062
Drug Development Updates
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