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
-

A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2023-01-13
Last Posted Date
2024-12-13
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT05683171
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Prognostic Model of Rituximab in the Treatment of MN

Not yet recruiting
Conditions
Interventions
First Posted Date
2022-12-29
Last Posted Date
2023-03-17
Lead Sponsor
Qianfoshan Hospital
Target Recruit Count
50
Registration Number
NCT05667909

Telitacicept Followed With Rituximab Therapy on APS Secondary to SLE

First Posted Date
2022-12-09
Last Posted Date
2022-12-09
Lead Sponsor
Qilu Hospital of Shandong University
Target Recruit Count
80
Registration Number
NCT05644210
Locations
🇨🇳

Qilu Hospital, Jinan, Shandong, China

Zanubrutinib Plus Rituximab for Patients with Indolent Mantle Cell Lymphoma

Phase 2
Recruiting
Conditions
Interventions
First Posted Date
2022-12-02
Last Posted Date
2024-12-06
Lead Sponsor
University College, London
Target Recruit Count
50
Registration Number
NCT05635162
Locations
🇬🇧

Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

🇬🇧

Guy's Hospital, London, United Kingdom

🇬🇧

Derriford Hospital, Plymouth, United Kingdom

and more 5 locations

A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)

First Posted Date
2022-11-22
Last Posted Date
2024-12-05
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
300
Registration Number
NCT05624554
Locations
🇺🇸

Highlands Oncology Group ( Site 5205), Springdale, Arkansas, United States

🇺🇸

Clermont Oncology Center ( Site 5224), Clermont, Florida, United States

🇺🇸

Hattiesburg Clinic Hematology/Oncology ( Site 5216), Hattiesburg, Mississippi, United States

and more 94 locations

A Randomized Controlled Trial With Rituximab for Psychotic Disorder in Adults

First Posted Date
2022-11-18
Last Posted Date
2024-12-18
Lead Sponsor
Region Örebro County
Target Recruit Count
120
Registration Number
NCT05622201
Locations
🇸🇪

Örebro university hospital, Örebro, Sweden

Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

First Posted Date
2022-11-16
Last Posted Date
2024-08-20
Lead Sponsor
ImmunityBio, Inc.
Target Recruit Count
20
Registration Number
NCT05618925
Locations
🇺🇸

Hoag Memorial Hospital, Newport Beach, California, United States

A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2022-11-14
Last Posted Date
2024-12-19
Lead Sponsor
LaNova Medicines Limited
Target Recruit Count
139
Registration Number
NCT05615974
Locations
🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

🇨🇳

Linyi Cancer Hospital, Linyi, Shandong, China

and more 2 locations

Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

First Posted Date
2022-11-04
Last Posted Date
2024-12-06
Lead Sponsor
Kite, A Gilead Company
Target Recruit Count
300
Registration Number
NCT05605899
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Mayo Clinic, Phoenix, Arizona, United States

🇺🇸

University of California Los Angeles (UCLA), Los Angeles, California, United States

and more 84 locations
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