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
-

Rapid Infusion of Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-05-07
Last Posted Date
2017-06-06
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
34
Registration Number
NCT01848145
Locations
🇺🇸

Colorado Blood Cancer Institute, Denver, Colorado, United States

🇺🇸

Florida Cancer Specialists-North, Saint Petersburg, Florida, United States

🇺🇸

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

and more 3 locations

Ofatumumab Induction and Maintenance in Elderly Patients With Poor Risk CLL in the Context of Allogeneic Transplantation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2013-03-13
Last Posted Date
2016-09-19
Lead Sponsor
Technische Universität Dresden
Target Recruit Count
20
Registration Number
NCT01809847
Locations
🇩🇪

Universitätsklinikum Dresden, Dresden, Sachsen, Germany

🇩🇪

Klinikum der Johannes Gutenberg Universität, Mainz, Rheinland-Pfalz, Germany

🇩🇪

Klinikum der Universität zu Köln, Köln, Nordrhein-Westfalen, Germany

and more 8 locations

Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.

First Posted Date
2013-01-07
Last Posted Date
2020-10-14
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
80
Registration Number
NCT01762202
Locations
🇮🇹

RCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente, Genova, Italy

🇮🇹

Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone", Palermo, Italy

🇮🇹

Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli", Reggio Calabria, Italy

and more 19 locations

Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-09-25
Last Posted Date
2018-02-28
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
30
Registration Number
NCT01691807
Locations
🇺🇸

Novartis Investigative Site, Morgantown, West Virginia, United States

Trial of Pentostatin Plus Cyclophosphamide With Ofatumumab (PCO) in Older Patients With Chronic Lymphocytic Leukemia

First Posted Date
2012-09-10
Last Posted Date
2016-12-28
Lead Sponsor
Niguarda Hospital
Target Recruit Count
47
Registration Number
NCT01681563
Locations
🇮🇹

IRCCS Policlinico San Matteo Pavia Istituto di Ematologia, Pavia, Italy

🇮🇹

Presidi Ospedalieri Spedali Civili di Brescia Divisione di Ematologia, Brescia, Italy

🇮🇹

Azienda Ospedaliera San Gerardo di Monza U.O. Ematologia, Monza, MB, Italy

and more 9 locations

Ofatumumab as Primary Therapy of Chronic Graft Versus Host Disease

Phase 1
Completed
Conditions
Interventions
First Posted Date
2012-09-07
Last Posted Date
2022-10-06
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
44
Registration Number
NCT01680965
Locations
🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

Mayo Clinic Cancer Center, Phoenix, Arizona, United States

and more 1 locations

A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment

First Posted Date
2012-09-05
Last Posted Date
2012-10-15
Lead Sponsor
University of Liverpool
Target Recruit Count
670
Registration Number
NCT01678430
Locations
🇬🇧

Derriford Hospital, Plymouth, Devon, United Kingdom

🇬🇧

Torbay Hospital, Torquay, Devon, United Kingdom

🇬🇧

Dorset County Hospital, Dorchester, Dorset, United Kingdom

and more 23 locations

Efficacy and Safety of Idelalisib in Combination With Ofatumumab for Previously Treated Chronic Lymphocytic Leukemia

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2012-08-07
Last Posted Date
2019-08-14
Lead Sponsor
Gilead Sciences
Target Recruit Count
261
Registration Number
NCT01659021
Locations
🇺🇸

Saint Mary's Regional Cancer Center, Grand Junction, Colorado, United States

🇺🇸

Northwest Medical Specialties, Tacoma, Washington, United States

🇺🇸

City of Hope, Duarte, California, United States

and more 75 locations

Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

First Posted Date
2012-06-22
Last Posted Date
2017-11-22
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
22
Registration Number
NCT01626352
Locations
🇺🇸

Woodlands Medical Specialists, Pensacola, Florida, United States

🇺🇸

Florida Cancer Specialists North, Saint Petersburg, Florida, United States

🇺🇸

Space Coast Cancer Center, Titusville, Florida, United States

and more 8 locations

Study of OFATUMUMAB as Part of the Scheme of Reduced Intensity Conditioning in High Risk Non-Hodgkin Lymphoma B Patients

Phase 2
Completed
Conditions
Interventions
First Posted Date
2012-06-07
Last Posted Date
2021-05-26
Lead Sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Target Recruit Count
33
Registration Number
NCT01613300
Locations
🇪🇸

H. Morales Meseguer., Murcia, Spain

🇪🇸

Hospital Vall d'Hebron, Barcelona, Spain

🇪🇸

H.U. La Paz, Madrid, Spain

and more 7 locations
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