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
-

Rituximab and Fludarabine Followed by CAMPATH-1H in Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2010-12-30
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
40
Registration Number
NCT00193466

Rituximab and Chemotherapy Followed by Ibritumomab Tiuxetan as Treatment for Low Grade Follicular Non-Hodgkin's Lymphoma

Phase 2
Completed
Conditions
First Posted Date
2005-09-19
Last Posted Date
2010-12-30
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
40
Registration Number
NCT00193440

Combination Chemotherapy and Rituximab With Pegfilgrastim Followed by Rituximab, in Large B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2005-09-19
Last Posted Date
2022-03-03
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
51
Registration Number
NCT00193479
Locations
🇺🇸

Tennessee Oncology, Nashville, Tennessee, United States

🇺🇸

Florida Cancer Specialists, Fort Myers, Florida, United States

A Study of Rituximab and Bevacizumab in Patients With Follicular Non-Hodgkin's Lymphoma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2005-09-19
Last Posted Date
2015-01-05
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
60
Registration Number
NCT00193492
Locations
🇺🇸

Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States

🇺🇸

Chattanooga Oncology Hematology Associates, Chattanooga, Tennessee, United States

🇺🇸

Oncology Hematology Care, Cincinnati, Ohio, United States

and more 19 locations

LMBA02 Protocol for Patients With a Burkitt Lymphoma

Phase 3
Conditions
First Posted Date
2005-09-16
Last Posted Date
2006-09-11
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
260
Registration Number
NCT00180882
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, France

Rituximab in Children and Adolescents With Relapsed and Refractory B-Cell NHL/L3ALL

Phase 2
Terminated
Conditions
First Posted Date
2005-09-16
Last Posted Date
2006-09-11
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Target Recruit Count
40
Registration Number
NCT00180895
Locations
🇫🇷

Institut Gustave Roussy, Villejuif, France

Treatment of Relapsed Low-Grade or Follicular Lymphoma With Rituximab (Also Known as Rituxan, IDEC-C2B8, IDEC-102)

First Posted Date
2005-09-15
Last Posted Date
2005-09-15
Lead Sponsor
Biogen
Target Recruit Count
150
Registration Number
NCT00168740
Locations
🇺🇸

Hoag Hospital, Newport Beach, California, United States

🇺🇸

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

🇺🇸

Robert H. Lurie Cancer Center, Northwestern University, Chicago, Illinois, United States

and more 28 locations

Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

Phase 3
Terminated
Conditions
First Posted Date
2005-09-15
Last Posted Date
2005-09-15
Lead Sponsor
Lymphoma Study Association
Target Recruit Count
430
Registration Number
NCT00169169
Locations
🇫🇷

Hôpital Henri Mondor, Créteil, France

🇫🇷

Hôpital Saint Louis, Paris, France

🇫🇷

Service d'Hématologie - Centre Hospitalier Lyon-Sud, Pierre-Bénite cedex, France

and more 2 locations

Fludarabine, Mitoxantrone and Rituximab in Relapsed or Primary Failing Advanced Follicular Non-Hodgkin's Lymphoma

First Posted Date
2005-09-15
Last Posted Date
2019-08-28
Lead Sponsor
Lymphoma Study Association
Target Recruit Count
50
Registration Number
NCT00169208
Locations
🇫🇷

Service d'Hématologie Hôpital St Louis, Paris, France

🇫🇷

Service de médecine D - Maladies du Sang CHU Angers, Angers, France

🇫🇷

Service d'hématologie Institut Paoli Calmette, Marseille, France

and more 13 locations
© Copyright 2024. All Rights Reserved by MedPath