CLINICAL TRIALS PROFILE FOR RITUXAN

Biosimilar Clinical Trials for RITUXAN

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05065554 ↗	ACALA-R In Anti-MAG Neuropathy Mediated Neuropathy	Not yet recruiting	AstraZeneca	Phase 2	2021-11-01	In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: - Acalabrutinib - Rituximab or similar CD20 antibody
NCT05065554 ↗	ACALA-R In Anti-MAG Neuropathy Mediated Neuropathy	Not yet recruiting	Jorge J. Castillo, MD	Phase 2	2021-11-01	In this research study, is combining a new treatment acalabrutinib with a standard treatment, rituximab or other CD20 antibody, to determine whether this combination is safe and effective for participants with Immunoglobulin (Ig) M monoclonal gammopathy of undetermined significance ( IgM MGUS) or Waldenström macroglobulinemia WM related neuropathies. The names of the study drugs involved in this study are/is: - Acalabrutinib - Rituximab or similar CD20 antibody
NCT04555811 ↗	FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL	Recruiting	Masonic Cancer Center, University of Minnesota	Phase 1	2020-09-22	This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.
NCT04323956 ↗	Parsaclisib Plus the Standard Drug Therapy in Patients With Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma	Recruiting	Mayo Clinic	Phase 1	2020-06-15	This phase I/Ib trial studies the side effects and best dose of parsaclisib plus the standard drug therapy (rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone [R-CHOP]) and to see how well they work compared with R-CHOP alone in treating patients with newly diagnosed, high risk diffuse large B-cell lymphoma. Parsaclisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and vincristine sulfate, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. It is not yet known if giving parsaclisib and R-CHOP together works better than R-CHOP alone in treating patients with high risk diffuse large B-cell lymphoma.

All Clinical Trials for RITUXAN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003820 ↗	Rituximab in Treating Patients With Hodgkin's Lymphoma	Completed	Genentech, Inc.	Phase 2	1999-01-01	Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
NCT00003820 ↗	Rituximab in Treating Patients With Hodgkin's Lymphoma	Completed	Ranjana Advani	Phase 2	1999-01-01	Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.
NCT00003554 ↗	Rituximab in Treating Patients With Multiple Myeloma	Completed	The Cleveland Clinic	Phase 2	1998-11-01	RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them. PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab in treating patients with multiple myeloma that is newly diagnosed.
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland Greenebaum Cancer Center	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003397 ↗	Peripheral Stem Cell Transplantation Plus Combination Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma	Completed	University of Maryland, Baltimore	Phase 2	1998-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus combination chemotherapy and rituximab in treating patients with non-Hodgkin's lymphoma.
NCT00003204 ↗	Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Low-Grade Non-Hodgkin's Lymphoma	Completed	National Cancer Institute (NCI)	Phase 3	1998-03-01	Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by rituximab or observation in treating patients who have stage III or stage IV low-grade non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known which regimen of combination chemotherapy, with or without rituximab, is more effective for non-Hodgkin's lymphoma

Clinical Trial Conditions for RITUXAN

Condition Name

Condition Name for RITUXAN
Intervention	Trials
Lymphoma	117
Leukemia	59
Chronic Lymphocytic Leukemia	53
Mantle Cell Lymphoma	39

Condition MeSH

Condition MeSH for RITUXAN
Intervention	Trials
Lymphoma	383
Lymphoma, Non-Hodgkin	167
Leukemia	149
Lymphoma, B-Cell	141

Clinical Trial Locations for RITUXAN

Trials by Country

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Trials by Country for RITUXAN
Location	Trials
Australia	66
France	57
Germany	42
Poland	38
United Kingdom	32

Trials by US State

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−

Trials by US State for RITUXAN
Location	Trials
Texas	194
New York	130
California	128
Ohio	105
Massachusetts	84

Clinical Trial Progress for RITUXAN

Clinical Trial Phase

Clinical Trial Phase for RITUXAN
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	64
Phase 2/Phase 3	15

Clinical Trial Status

Clinical Trial Status for RITUXAN
Clinical Trial Phase	Trials
Completed	298
Recruiting	102
Terminated	94

Clinical Trial Sponsors for RITUXAN

Sponsor Name

Sponsor Name for RITUXAN
Sponsor	Trials
National Cancer Institute (NCI)	183
M.D. Anderson Cancer Center	125
Genentech, Inc.	79

Sponsor Type

Sponsor Type for RITUXAN
Sponsor	Trials
Other	636
Industry	421
NIH	217

RITUXAN (Rituximab): Clinical Trials, Market Analysis, and Projections

Introduction to RITUXAN (Rituximab)

RITUXAN, or rituximab, is a monoclonal antibody used in the treatment of various conditions, including rheumatoid arthritis (RA), non-Hodgkin's lymphoma, and certain autoimmune diseases. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials: Efficacy and Safety

REFLEX Trial for Rheumatoid Arthritis

One of the pivotal clinical trials for RITUXAN in the context of rheumatoid arthritis is the REFLEX trial. This 24-week study enrolled 520 patients with active RA who had an inadequate response to at least one tumor necrosis factor inhibitor (TNFi) therapy. Patients were randomized to receive either RITUXAN plus methotrexate (MTX) or placebo plus MTX. The primary endpoint was the American College of Rheumatology 20% response criteria (ACR20) at 6 months.

• Key Findings: The REFLEX trial showed that 51% of patients treated with RITUXAN plus MTX achieved an ACR20 response at 6 months, compared to those receiving placebo plus MTX. Additionally, RITUXAN plus MTX slowed joint damage in 60% of patients during the first year, compared to 46% in the placebo group[1][4].

Combination Therapy in Lymphoma

Recent clinical trials have also explored the efficacy of RITUXAN in combination with other therapies. For instance, a Phase 2 clinical trial evaluating ZYNLONTA (loncastuximab tesirine-lpyl) in combination with RITUXAN in patients with relapsed or refractory follicular lymphoma showed promising results. The trial, conducted at the Sylvester Comprehensive Cancer Center, reported a high response rate among the 27 evaluable patients, indicating a potential new treatment option for this high-risk population[3].

Market Analysis

Current Market Size

The global market for RITUXAN (rituximab) is substantial and growing. As of 2023, the market size was estimated to be around $4.125 billion[2].

Forecasted Market Size

• 2024-2030: The market is forecasted to grow to $5.3067 million by 2030, with a compound annual growth rate (CAGR) of 3.5% during the forecast period[2].
• 2025-2037: A more extended forecast predicts the market to reach $27.13 billion by 2037, with a CAGR of over 15.8% during this period[5].

Key Players

The main players in the RITUXAN market include Roche, Teva, Pfizer, and Amgen. These companies play a significant role in the production, distribution, and marketing of the drug[2].

Distribution Channels

Hospital pharmacies are expected to dominate the distribution channel segment, accounting for a significant market share due to the increasing use of RITUXAN in cancer therapy within hospital settings. Retail and online pharmacies also contribute to the market, but hospital pharmacies are anticipated to maintain the largest revenue share by 2037[5].

Growth Drivers

Increasing Incidence of Non-Hodgkin’s Lymphoma

The rising incidence of non-Hodgkin’s lymphoma (NHL) is a major driver for the growth of the RITUXAN market. According to the American Cancer Society, NHL is one of the most common cancers in the USA, with around 77,200 cases registered in 2020. This trend is expected to continue, boosting the demand for RITUXAN[5].

Prevalence of Autoimmune Diseases

Autoimmune diseases, such as rheumatoid arthritis, granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), are also driving the market growth. Approximately 22 million people are affected by autoimmune diseases annually, which is likely to accelerate the demand for RITUXAN[5].

Challenges and Side Effects

Serious Side Effects

RITUXAN can cause serious side effects, including tumor lysis syndrome (TLS), which can occur within 12 to 24 hours after infusion. Other severe side effects include infections, infusion reactions, and cardiac complications. These risks necessitate careful monitoring and management by healthcare providers[4].

Regulatory and Economic Challenges

The market also faces regulatory challenges, such as stringent approval processes and patent expirations, which can impact the market dynamics. Economic factors, including healthcare spending and reimbursement policies, also influence the market growth[5].

Applications of RITUXAN

Rheumatoid Arthritis

RITUXAN is used in combination with methotrexate to treat moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to one or more TNFi therapies[4].

Blood Cancers

RITUXAN is indicated for the treatment of non-Hodgkin’s lymphoma and other blood cancers. Its efficacy in combination with other therapies, as seen in recent clinical trials, makes it a versatile treatment option[3].

Autoimmune Diseases

In addition to RA, RITUXAN is used to treat GPA, MPA, and pemphigus vulgaris. Its ability to target and deplete B cells makes it effective in managing these autoimmune conditions[4].

Future Projections

Expanding Clinical Trials

Future clinical trials, such as the planned multicenter trial evaluating ZYNLONTA in combination with RITUXAN, are expected to expand the treatment options for patients with relapsed or refractory follicular lymphoma. These trials aim to decrease the length of therapy and improve patient outcomes[3].

Market Expansion

The projected growth of the RITUXAN market to $27.13 billion by 2037 indicates a strong future for this drug. Increasing healthcare spending, growing awareness among patients, and the availability of superior hospital infrastructure are expected to drive this growth[5].

Key Takeaways

• Clinical Efficacy: RITUXAN has shown significant efficacy in clinical trials, particularly in the REFLEX trial for rheumatoid arthritis and in combination therapies for lymphoma.
• Market Growth: The global market for RITUXAN is forecasted to grow substantially, driven by increasing incidences of non-Hodgkin’s lymphoma and autoimmune diseases.
• Applications: RITUXAN is used in treating rheumatoid arthritis, blood cancers, and certain autoimmune diseases.
• Challenges: Despite its efficacy, RITUXAN can cause serious side effects and faces regulatory and economic challenges.

FAQs

What is the primary use of RITUXAN in rheumatoid arthritis?

RITUXAN is used in combination with methotrexate to treat moderate to severe active rheumatoid arthritis in patients who have had an inadequate response to one or more TNFi therapies[4].

What are the serious side effects associated with RITUXAN?

RITUXAN can cause serious side effects, including tumor lysis syndrome (TLS), infections, infusion reactions, and cardiac complications[4].

What is the forecasted market size of RITUXAN by 2037?

The market for RITUXAN is expected to reach $27.13 billion by 2037, with a CAGR of over 15.8% during the forecast period[5].

Which companies are the main players in the RITUXAN market?

The main players in the RITUXAN market include Roche, Teva, Pfizer, and Amgen[2].

What are the key drivers for the growth of the RITUXAN market?

The increasing incidence of non-Hodgkin’s lymphoma and the prevalence of autoimmune diseases are major drivers for the growth of the RITUXAN market[5].

Sources

1. RITUXAN-HCP: REFLEX Clinical Trial of RITUXAN® (rituximab) in Rheumatoid Arthritis.
2. Valuates Reports: Rituxan (rituximab) Drug - Market Size.
3. ADC Therapeutics: Initial Results from Investigator-Initiated Phase 2 Clinical Trial Evaluating ZYNLONTA in Combination with Rituximab.
4. RITUXAN: Efficacy and Safety in RA Clinical Trials.
5. Research Nester: Rituximab Market Size & Share, Global Forecast Report 2037.