Rituximab

Generic Name
Rituximab
Brand Names
MabThera, Riabni, Rituxan, Rituxan Hycela, Ruxience, Truxima, Blitzima, Rixathon, Riximyo
Drug Type
Biotech
Chemical Formula
-
CAS Number
174722-31-7
Unique Ingredient Identifier
4F4X42SYQ6
Background

Rituximab is a genetically engineered chimeric murine/human monoclonal antibody directed against the CD20 antigen found on the surface of normal and malignant B lymphocytes. The antibody is an IgG1 kappa immunoglobulin containing murine light and heavy-chain variable region sequences and human constant region sequences , . It was originally approved by the U.S. FDA in 1997 as a single agent to treat patients with B-cell Non-Hodgkin's Lymphoma (NHL) , however, has now been approved for a variety of conditions . On November 28, 2018, the US FDA approved Truxima, the first biosimilar to Rituxan (Rituximab) .

Indication

Rituximab is indicated for the treatment of adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s Lymphoma (NHL) as a single agent. Also, it is indicated for the treatment of adult patients with previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Additionally, rituximab is indicated for the treatment of adult patients with non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; and previously untreated diffuse large B-cell, CD20-positive NHL in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens.

Rituximab, in combination with fludarabine and cyclophosphamide (FC), is indicated for the treatment of adult patients with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL). In combination with methotrexate, rituximab is indicated for the treatment of adult patients with moderately-to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies. Additionally, rituximab, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA).

RITUXAN (rituximab injection for intravenous use) is indicated for the treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy; as well as the treatment of adult patients with moderate to severe pemphigus vulgaris. These indications for RITUXAN are not included in the labels of rituximab biosimilar products (rituximab-arrx, rituximab-abbs, rituximab-pvvr). The combination product RITUXAN HYCELA (rituximab and hyaluronidase human injection, for subcutaneous use) is not indicated for the treatment of non-malignant conditions.

Associated Conditions
Active, Moderate to Severe Rheumatoid Arthritis, Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Non-Hodgkin's Lymphoma, Granulomatosis With Polyangiitis, Microscopic Polyangiitis (MPA), Advanced Burkitt Lymphoma (BL), Advanced Burkitt-like lymphoma, Advanced Diffuse Large B-Cell Lymphoma (DLBCL), Advanced Mature B-cell type acute leukaemia, Moderate Pemphigus Vulgaris (PV), Non-progressive Low Grade Non-Hodgkin's Lymphoma (NHL), Refractory Low Grade Non-Hodgkin's Lymphoma (NHL), Refractory follicular B-cell non-Hodgkin's lymphoma, Relapsed Low Grade Non-Hodgkin's Lymphoma (NHL), Relapsed follicular B-cell non-Hodgkin's lymphoma, Severe Pemphigus Vulgaris (PV)
Associated Therapies
-

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

First Posted Date
2006-01-25
Last Posted Date
2013-09-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
817
Registration Number
NCT00281918
Locations
🇩🇪

Praxis Fur Hamatologie und Onkologie Ahaus, Ahaus, Germany

🇩🇪

Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg, Augsburg, Germany

🇩🇪

Onkologische Schwerpunktpraxis Bielefeld, Bielefeld, Germany

and more 157 locations

Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma

Phase 2
Completed
Conditions
First Posted Date
2006-01-24
Last Posted Date
2016-01-15
Lead Sponsor
Bayside Health
Target Recruit Count
12
Registration Number
NCT00280878
Locations
🇦🇺

Frankston Hospital, Melbourne, Victoria, Australia

🇦🇺

The Alfred Hospital, Melbourne, Victoria, Australia

Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia

First Posted Date
2006-01-20
Last Posted Date
2016-02-04
Lead Sponsor
University of Pittsburgh
Target Recruit Count
65
Registration Number
NCT00280241
Locations
🇺🇸

Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases

First Posted Date
2006-01-18
Last Posted Date
2018-08-06
Lead Sponsor
Northwestern University
Target Recruit Count
7
Registration Number
NCT00278564
Locations
🇺🇸

Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States

Pilot Study of Rituximab for Membranoproliferative Glomerulonephritis

Phase 1
Completed
Conditions
Interventions
First Posted Date
2006-01-12
Last Posted Date
2013-01-16
Lead Sponsor
Mayo Clinic
Target Recruit Count
10
Registration Number
NCT00275613
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma

First Posted Date
2005-12-21
Last Posted Date
2020-06-01
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
12
Registration Number
NCT00267865
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Immunopharmacological Effects of Rituximab in Atopic Dermatitis

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2005-12-21
Last Posted Date
2008-06-17
Lead Sponsor
University of Bern
Target Recruit Count
6
Registration Number
NCT00267826
Locations
🇨🇭

University of Bern, Department of Dermatology, Bern, Switzerland

A Study of Retreatment With Rituximab in Patients With Rheumatoid Arthritis Receiving Background Methotrexate

First Posted Date
2005-12-16
Last Posted Date
2013-10-25
Lead Sponsor
Genentech, Inc.
Target Recruit Count
559
Registration Number
NCT00266227

Bortezomib and Rituximab in Treating Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Phase 2
Terminated
Conditions
First Posted Date
2005-12-15
Last Posted Date
2008-01-28
Lead Sponsor
University of Virginia
Target Recruit Count
46
Registration Number
NCT00265928
Locations
🇺🇸

University of Virginia Cancer Center at UV Health System, Charlottesville, Virginia, United States

Bortezomib, Rituximab and Dexamethasone (BORID) for Relapsed/Refractory Mantle Cell Lymphoma

Phase 2
Conditions
First Posted Date
2005-12-05
Last Posted Date
2006-10-18
Lead Sponsor
Medical University of Vienna
Target Recruit Count
16
Registration Number
NCT00261612
Locations
🇦🇹

Medical University Vienna, Dept. of Medicine I, Clinical Division of Oncology, Vienna, Austria

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