MedPath

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 in Eosinophilic Granulomatosis With Polyangiitis

Phase 3
Completed
Conditions
Eosinophilic Granulomatosis With Polyangiitis (EGPA)
Interventions
Drug: Placebo-rituximab
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Placebo-cyclophosphamide
First Posted Date
2016-06-21
Last Posted Date
2021-04-14
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Target Recruit Count
107
Registration Number
NCT02807103
Locations
🇫🇷

Hôpital Cochin, Paris, France

Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation

Phase 2
Active, not recruiting
Conditions
Myeloid Sarcoma
Chronic Myeloid Leukemia (CML)
Myelodysplastic Syndrome (MDS)
Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemia (AML)
Non-Hodgkin Lymphoma (NHL)
Juvenile Myelomonocytic Leukemia (JMML)
Interventions
First Posted Date
2016-06-06
Last Posted Date
2024-10-09
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
170
Registration Number
NCT02790515
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Clinical Study to Compare the Efficacy and Safety of Rituximab Biosimilar HLX01 and Rituximab in Combination With CHOP, in Previously Untreated Subjects With CD20+ DLBCL

Phase 3
Completed
Conditions
B-cell Non Hodgkin's Lymphoma
Interventions
Drug: HLX01
Drug: Rituximab
Drug: CHOP
First Posted Date
2016-06-01
Last Posted Date
2022-05-09
Lead Sponsor
Shanghai Henlius Biotech
Target Recruit Count
407
Registration Number
NCT02787239
Locations
🇨🇳

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

First Posted Date
2016-05-10
Last Posted Date
2019-01-03
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
258
Registration Number
NCT02767674
Locations
🇨🇳

Shandong Province Hospital, Jinan, Shandong, China

🇨🇳

Tongji Medical College of HUST, Wuhan, Hubei, China

🇨🇳

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital), NanJing, Jiangsu, China

and more 3 locations

CyBeR Association in Relapsed/Refractory DLBCL

Phase 2
Conditions
Diffuse Large B Cell Lymphoma
Interventions
First Posted Date
2016-05-03
Last Posted Date
2016-05-04
Lead Sponsor
University Hospital, Caen
Target Recruit Count
78
Registration Number
NCT02758925

Chidamide Plus R-CHOP in Elderly DLBCL

First Posted Date
2016-04-28
Last Posted Date
2017-11-14
Lead Sponsor
Ruijin Hospital
Target Recruit Count
49
Registration Number
NCT02753647
Locations
🇨🇳

Shanghai Ruijin Hospital, Shanghai, Shanghai, China

Reduced Chemotherapy in Low Risk DLBCL

Phase 4
Active, not recruiting
Conditions
Diffuse Large B-cell Lymphoma
Interventions
First Posted Date
2016-04-27
Last Posted Date
2022-12-05
Lead Sponsor
Ruijin Hospital
Target Recruit Count
290
Registration Number
NCT02752815
Locations
🇨🇳

Shanghai Ruijin Hospital, Shanghai, Shanghai, China

An Evaluation AZD2014 Alone and in Combination With Rituximab in Relapsed/Refractory Diffuse Large B Cell Lymphoma

Phase 2
Completed
Conditions
Diffuse Large B-Cell Lymphoma
Interventions
Drug: AZD 2014
Drug: Rituximab
First Posted Date
2016-04-26
Last Posted Date
2020-11-05
Lead Sponsor
University of Birmingham
Target Recruit Count
36
Registration Number
NCT02752204
Locations
🇬🇧

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

🇬🇧

University College London Hospitals, London, United Kingdom

🇬🇧

Guys Hospital, London, United Kingdom

and more 6 locations

Maintenance of ANCA Vasculitis Remission by Intermittent Rituximab Dosing

Phase 4
Terminated
Conditions
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Interventions
First Posted Date
2016-04-22
Last Posted Date
2023-07-27
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
115
Registration Number
NCT02749292
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

Phase 3
Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2016-04-21
Last Posted Date
2021-10-12
Lead Sponsor
Anders Svenningsson
Target Recruit Count
200
Registration Number
NCT02746744
Locations
🇸🇪

Fredrik Piehl, Stockholm, Sweden

🇸🇪

South Älvsborg Hospital, Borås, Sweden

🇸🇪

Falun Hospital, Falun, Sweden

and more 14 locations
© Copyright 2025. All Rights Reserved by MedPath