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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
-

Autologous Transplant To End NMO Spectrum Disorder

Phase 2
Withdrawn
Conditions
Neuromyelitis Optica
Devic's Disease
NMO Spectrum Disorder
Interventions
First Posted Date
2019-02-04
Last Posted Date
2019-11-20
Lead Sponsor
Northwestern University
Registration Number
NCT03829566
Locations
🇺🇸

Northwestern University, Chicago, Illinois, United States

🇺🇸

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

Personalized Medicine for Membranous Nephropathy

Phase 2
Conditions
Idiopathic Membranous Nephropathy
Interventions
First Posted Date
2019-01-15
Last Posted Date
2020-02-11
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
64
Registration Number
NCT03804359
Locations
🇫🇷

CHU D'amiens Hôpital Sud, Amiens, France

🇫🇷

CHU Gabriel Montpied, Clermont-Ferrand, France

🇫🇷

CHU Carémeau, Nîmes, France

and more 16 locations

The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide

Phase 2
Active, not recruiting
Conditions
Large-B-cell Diffuse Lymphoma
Chronic Lymphoid Leukemia
Interventions
First Posted Date
2019-01-15
Last Posted Date
2024-10-22
Lead Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Target Recruit Count
5
Registration Number
NCT03804372
Locations
🇮🇹

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia, Roma, (rm), Italy

🇮🇹

Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia, Alessandria, Italy

🇮🇹

Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica, Ancona, Italy

and more 28 locations

Lenalidomide, Rituximab, Gemcitabine, Oxaliplatin and Dexamethasone in Relapse and Refractory DLBCL

Phase 1
Conditions
Diffuse Large B-cell Lymphoma Recurrent
Diffuse Large B Cell Lymphoma Refractory
Interventions
First Posted Date
2019-01-07
Last Posted Date
2019-02-15
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
12
Registration Number
NCT03795571
Locations
🇨🇳

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

Multicenter Registry of Pediatric Lupus Nephritis in China

Recruiting
Conditions
Lupus Nephritis
Children
Steroid
Immunosuppressive Treatment
Interventions
First Posted Date
2019-01-03
Last Posted Date
2019-04-05
Lead Sponsor
Xiqiang Dang
Target Recruit Count
1200
Registration Number
NCT03791827
Locations
🇨🇳

The Second Xiangya Hospital, Central South University, Changsha, Hunan, China

Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the "RITUXIMAB 3" Trial

Phase 3
Conditions
Autoimmune Diseases
Interventions
Drug: corticosteroids'therapy
Drug: Rituximab
First Posted Date
2018-12-31
Last Posted Date
2018-12-31
Lead Sponsor
University Hospital, Rouen
Target Recruit Count
90
Registration Number
NCT03790293

Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma

Phase 2
Active, not recruiting
Conditions
Follicular Lymphoma
Non-Hodgkin's Lymphoma
NHL
Interventions
First Posted Date
2018-12-28
Last Posted Date
2024-12-17
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
22
Registration Number
NCT03789240
Locations
🇺🇸

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

Acalabrutinib and High Frequency Low Dose Subcutaneous Rituximab in Patients With Previously Untreated Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma

Phase 2
Active, not recruiting
Conditions
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Interventions
First Posted Date
2018-12-27
Last Posted Date
2024-03-07
Lead Sponsor
University of Rochester
Target Recruit Count
39
Registration Number
NCT03788291
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

A Study of CC-95251, a Monoclonal Antibody Directed Against SIRPα, in Participants With Advanced Solid and Hematologic Cancers

Phase 1
Active, not recruiting
Conditions
Neoplasms
Interventions
First Posted Date
2018-12-21
Last Posted Date
2024-08-09
Lead Sponsor
Celgene
Target Recruit Count
230
Registration Number
NCT03783403
Locations
🇺🇸

Local Institution - 107, Pittsburgh, Pennsylvania, United States

🇺🇸

Local Institution - 108, Houston, Texas, United States

🇺🇸

Local Institution - 103, San Antonio, Texas, United States

and more 28 locations

MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin

Phase 1
Conditions
Relapsed Non Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Interventions
Drug: Rituximab
Drug: Fludarabine
Drug: Cyclophosphamide
Biological: MG4101(allogeneic Natural Killer cell)
Drug: Interleukin-2
First Posted Date
2018-12-19
Last Posted Date
2020-07-28
Lead Sponsor
GC Cell Corporation
Target Recruit Count
9
Registration Number
NCT03778619
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

🇰🇷

Seoul National Univ. Hospital, Seoul, Korea, Republic of

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