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
-

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

First Posted Date
2022-06-16
Last Posted Date
2024-06-17
Lead Sponsor
Li Zhiming
Target Recruit Count
50
Registration Number
NCT05422066
Locations
🇨🇳

Henan Cancer Hospital, Zhengzhou, Henan, China

🇨🇳

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

🇨🇳

Hubei Cancer Hospital, Wuhan, Hubei, China

and more 3 locations

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

First Posted Date
2022-06-08
Last Posted Date
2024-12-04
Lead Sponsor
Genmab
Target Recruit Count
500
Registration Number
NCT05409066
Locations
🇺🇸

University of Arkansas for Medical Sciences /ID# 227198, Little Rock, Arkansas, United States

🇺🇸

Beverly Hills Cancer Center /ID# 231535, Beverly Hills, California, United States

🇺🇸

Valkyrie Clinical Trials /ID# 268502, Los Angeles, California, United States

and more 270 locations

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Cyclophosphamide, Doxorubicin, and Prednisone Plus Rituximab or Rituximab Biosimilar (Truxima) (R-CHP) in Participants With Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-007)

First Posted Date
2022-06-06
Last Posted Date
2024-10-14
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
60
Registration Number
NCT05406401
Locations
🇰🇷

Seoul National University Hospital ( Site 0201), Seoul, Korea, Republic of

🇰🇷

Samsung Medical Center ( Site 0200), Seoul, Korea, Republic of

🇨🇦

BC Cancer Victoria-Clinical Trials Unit ( Site 0105), Victoria, British Columbia, Canada

and more 19 locations

Pomalidomide and Dose-Adjusted EPOCH +/- Rituximab for HIV-Associated Lymphomas

First Posted Date
2022-05-25
Last Posted Date
2024-11-27
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT05389423
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL

First Posted Date
2022-05-25
Last Posted Date
2022-05-25
Lead Sponsor
Peking Union Medical College Hospital
Target Recruit Count
50
Registration Number
NCT05390749
Locations
🇨🇳

Peking Union Medical College Hospital, Beijing, Beijing, China

🇨🇳

Sanbo Brain Hospital Capital Medical University, Beijing, Beijing, China

🇨🇳

Beijing TianTan Hospital, Beijing, Beijing, China

Natural Killer (NK) Cell Therapy for B-Cell Malignancies

First Posted Date
2022-05-18
Last Posted Date
2022-05-18
Lead Sponsor
Zhejiang University
Target Recruit Count
24
Registration Number
NCT05379647
Locations
🇨🇳

The First Affiliated Hospital of Medical College of Zhejiang University, Hangzhou, Zhejiang, China

PR3-AAV Resilient Remission or PRRR

First Posted Date
2022-05-17
Last Posted Date
2024-07-31
Lead Sponsor
Mayo Clinic
Target Recruit Count
6
Registration Number
NCT05376319
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Mayo Clinic Rochester, Rochester, Minnesota, United States

🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

First Posted Date
2022-05-12
Last Posted Date
2024-11-22
Lead Sponsor
Kite, A Gilead Company
Target Recruit Count
230
Registration Number
NCT05371093
Locations
🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

🇺🇸

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte, California, United States

🇺🇸

UC Irvine Health, Orange, California, United States

and more 65 locations

A Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Participants With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

First Posted Date
2022-05-06
Last Posted Date
2024-12-19
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
40
Registration Number
NCT05364424
Locations
🇺🇸

Chao Family Comprehensive Cancer Center UCI, Orange, California, United States

🇺🇸

Memorial Cancer Institute at Memorial West, Pembroke Pines, Florida, United States

🇺🇸

The University of Chicago, Chicago, Illinois, United States

and more 6 locations
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