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
- -
Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia
- Conditions
- Interventions
- Biological: BlinatumomabDrug: CyclophosphamideDrug: CytarabineDrug: DexamethasoneDrug: Doxorubicin HydrochlorideBiological: Inotuzumab OzogamicinOther: Laboratory Biomarker AnalysisDrug: MercaptopurineDrug: MethotrexateBiological: OfatumumabDrug: PrednisoneBiological: RituximabDrug: Vincristine Sulfate
- First Posted Date
- 2016-08-24
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 80
- Registration Number
- NCT02877303
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
"MIRO" Molecularly Oriented Immuno-radio-therapy
- Conditions
- Interventions
- First Posted Date
- 2016-03-17
- Last Posted Date
- 2022-06-21
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- Target Recruit Count
- 110
- Registration Number
- NCT02710643
- Locations
- 🇮🇹
Ospedale SS. Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy
🇮🇹Area Vasta Romagna e IRST, Meldola (FC), Italy
🇮🇹Ematologia Azienda Ospedaliera Policlinico, Bari, BA, Italy
Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)
- Conditions
- Interventions
- First Posted Date
- 2016-02-23
- Last Posted Date
- 2020-06-11
- Lead Sponsor
- German CLL Study Group
- Target Recruit Count
- 66
- Registration Number
- NCT02689141
- Locations
- 🇩🇪
German CLL Study Group, Cologne, Germany
Long-Term Extension Study of Ofatumumab in Subjects With Pemphigus Vulgaris
- Conditions
- Interventions
- First Posted Date
- 2015-11-25
- Last Posted Date
- 2017-06-14
- Lead Sponsor
- GlaxoSmithKline
- Target Recruit Count
- 1
- Registration Number
- NCT02613910
- Locations
- 🇺🇸
GSK Investigational Site, Ann Arbor, Michigan, United States
Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2015-04-17
- Last Posted Date
- 2018-06-11
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 1
- Registration Number
- NCT02419469
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Ofatumumab in Children With Drug Resistant Idiopathic Nephrotic Syndrome
- First Posted Date
- 2015-03-20
- Last Posted Date
- 2020-07-29
- Lead Sponsor
- Istituto Giannina Gaslini
- Target Recruit Count
- 13
- Registration Number
- NCT02394106
- Locations
- 🇮🇹
IRCCS Istituto Giannina Gaslini, Genoa, Italy/GE, Italy
Ofatumumab Versus Rituximab in Children With Steroid and Calcineurin Inhibitor Dependent Idiopathic Nephrotic Syndrome
- First Posted Date
- 2015-03-20
- Last Posted Date
- 2020-07-30
- Lead Sponsor
- Istituto Giannina Gaslini
- Target Recruit Count
- 140
- Registration Number
- NCT02394119
- Locations
- 🇮🇹
IRCCS Istituto Giannina Gaslini, Genoa, Italy/GE, Italy
A Study of Idelalisib (GS1101, CAL101) + Ofatumumab in Previously Untreated CLL/SLL
- Conditions
- Interventions
- First Posted Date
- 2014-05-09
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 27
- Registration Number
- NCT02135133
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07
- Conditions
- Interventions
- First Posted Date
- 2014-01-30
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 99
- Registration Number
- NCT02049515
A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
- Conditions
- Interventions
- First Posted Date
- 2013-12-09
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 319
- Registration Number
- NCT02004522
Drug Development Updates
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