CLINICAL TRIALS PROFILE FOR CELLCEPT

All Clinical Trials for CELLCEPT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003954 ↗	Melphalan and Stem Cell Transplant Before Total-Body Irradiation and Donor Stem Cell Transplant in Treating Patients With Stage I-III Multiple Myeloma	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	1999-03-01	In this study donor bone marrow transplantation is divided into a two step process to try to significantly reduce the side effects of the procedure yet still provide patients with multiple myeloma the benefits of this procedure
NCT00003196 ↗	Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma	Completed	National Cancer Institute (NCI)	N/A	1997-09-01	This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood stem cell transplant followed by donor lymphocyte infusion in treatment patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
NCT00003196 ↗	Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	1997-09-01	This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood stem cell transplant followed by donor lymphocyte infusion in treatment patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
NCT00003196 ↗	Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma	Completed	Fred Hutchinson Cancer Research Center	N/A	1997-09-01	This pilot clinical trial studies low-dose total body irradiation and donor peripheral blood stem cell transplant followed by donor lymphocyte infusion in treatment patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, or multiple myeloma. Giving total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
NCT00003145 ↗	Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	1997-08-01	This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older patients with chronic myeloid leukemia. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
NCT00003145 ↗	Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia	Completed	Fred Hutchinson Cancer Research Center	Phase 2	1997-08-01	This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older patients with chronic myeloid leukemia. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.

Clinical Trial Conditions for CELLCEPT

Condition Name

Condition Name for CELLCEPT
Intervention	Trials
Kidney Transplantation	40
Acute Myeloid Leukemia	29
Refractory Chronic Lymphocytic Leukemia	28
Recurrent Small Lymphocytic Lymphoma	28

Condition MeSH

Condition MeSH for CELLCEPT
Intervention	Trials
Leukemia	97
Myelodysplastic Syndromes	78
Preleukemia	75
Leukemia, Myeloid, Acute	73

Clinical Trial Locations for CELLCEPT

Trials by Country

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Trials by Country for CELLCEPT
Location	Trials
United States	799
Canada	75
Germany	36
China	27
Italy	24

Trials by US State

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−

Trials by US State for CELLCEPT
Location	Trials
Washington	80
California	72
Texas	54
Pennsylvania	46
New York	37

Clinical Trial Progress for CELLCEPT

Clinical Trial Phase

Clinical Trial Phase for CELLCEPT
Clinical Trial Phase	Trials
Phase 4	77
Phase 3	51
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for CELLCEPT
Clinical Trial Phase	Trials
Completed	222
Terminated	56
Recruiting	48

Clinical Trial Sponsors for CELLCEPT

Sponsor Name

Sponsor Name for CELLCEPT
Sponsor	Trials
National Cancer Institute (NCI)	107
Fred Hutchinson Cancer Research Center	66
Hoffmann-La Roche	42

Sponsor Type

Sponsor Type for CELLCEPT
Sponsor	Trials
Other	422
Industry	175
NIH	158

CELLCEPT (Mycophenolate Mofetil): Clinical Trials, Market Analysis, and Projections

Introduction

CELLCEPT, known generically as mycophenolate mofetil (MMF), is a potent immunosuppressive drug widely used in the prevention of organ rejection in transplant patients and the treatment of various autoimmune diseases. Here, we will delve into recent clinical trials, market analysis, and future projections for this crucial medication.

Clinical Trials Update

Systemic Lupus Erythematosus (SLE)

A recent randomized clinical trial published in JAMA Network Open highlighted the efficacy of MMF in patients with newly diagnosed SLE. The study, conducted in three hospitals across China, involved 130 participants and found that MMF, in addition to oral prednisone and hydroxychloroquine sulfate, significantly decreased severe flares. The primary outcome was the proportion of patients presenting with flares according to the SELENA-SLEDAI Flare Index, showing a favorable outcome for the MMF-treated group[1].

Pediatric Lupus Nephritis

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study is an ongoing clinical trial that aims to evaluate the efficacy of MMF in pediatric patients with lupus nephritis. This 1-year, two-part, double-blinded placebo-controlled trial assesses the clinical remission of lupus nephritis using different dosing regimens of MMF. The study is crucial for understanding the optimal treatment strategies for pediatric patients with this condition[4].

Market Analysis

Current Market Size and Growth

The global mycophenolate mofetil market was valued at USD 18 billion in 2023 and is projected to reach USD 24.63 billion by 2031, growing at a compound annual growth rate (CAGR) of 5.3% from 2024 to 2031. This growth is driven by the drug's effectiveness in controlling autoimmune disorders and preventing organ rejection in transplant patients[2][5].

Market Segmentation

The market is segmented based on application (tablets, oral suspensions, capsules) and product (organ transplantation, autoimmune diseases). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. The Asia-Pacific region is expected to be a significant contributor to the market growth due to the increasing healthcare infrastructure and rising rates of organ transplants[2][5].

Key Drivers

The market expansion is fueled by several factors:

• Effectiveness in Autoimmune Disorders: MMF's ability to specifically block the development of antibodies and lymphocytes makes it a preferred choice for managing autoimmune diseases.
• Rising Organ Transplant Rates: Increasing numbers of kidney, liver, and heart transplants globally drive the demand for MMF.
• Healthcare Infrastructure Development: Improvements in healthcare infrastructure in developing nations make MMF therapy more accessible.
• Strategic Partnerships: Collaborations between pharmaceutical companies and healthcare institutions enhance drug availability and affordability[2].

Market Projections

Future Growth

The global mycophenolate mofetil market is expected to continue its upward trajectory, driven by the increasing prevalence of autoimmune diseases and the growing need for effective immunosuppressive therapies. The market's CAGR of 5.3% from 2024 to 2031 indicates a steady and significant growth period[2].

Regional Expansion

The Asia-Pacific region is anticipated to be one of the fastest-growing segments due to its large patient population and advancing healthcare systems. North America and Europe will also remain key markets due to their well-established healthcare infrastructures and high adoption rates of MMF[2][5].

Competitive Landscape

The market is competitive, with key players such as Roche, Novartis, Pfizer, Teva, Mylan, AbbVie, Johnson & Johnson, Merck, GSK, and Sanofi. These companies are involved in various strategies including new product launches, collaborations, and acquisitions to maintain their market share and stay ahead in the competition[2].

Key Takeaways

• Clinical Efficacy: MMF has shown significant efficacy in reducing severe flares in SLE patients and is being studied for its effectiveness in pediatric lupus nephritis.
• Market Growth: The global MMF market is projected to grow from USD 18 billion in 2023 to USD 24.63 billion by 2031, driven by its effectiveness in autoimmune diseases and organ transplantation.
• Regional Expansion: The Asia-Pacific region is expected to be a major contributor to market growth due to its expanding healthcare infrastructure.
• Competitive Landscape: The market is highly competitive, with major pharmaceutical companies engaging in various strategies to maintain their market share.

FAQs

What is the primary use of mycophenolate mofetil (MMF)?

MMF is primarily used to prevent organ rejection in transplant patients and to treat various autoimmune diseases such as systemic lupus erythematosus (SLE).

What are the key drivers of the MMF market growth?

The key drivers include the drug's effectiveness in controlling autoimmune disorders, rising rates of organ transplants, development of healthcare infrastructure, and strategic partnerships between pharmaceutical companies and healthcare institutions.

Which regions are expected to contribute significantly to the MMF market growth?

The Asia-Pacific region, along with North America and Europe, is expected to be a significant contributor to the market growth due to their large patient populations and advancing healthcare systems.

What is the projected CAGR of the global MMF market from 2024 to 2031?

The global MMF market is expected to grow at a CAGR of 5.3% from 2024 to 2031.

Who are the key players in the MMF market?

Key players include Roche, Novartis, Pfizer, Teva, Mylan, AbbVie, Johnson & Johnson, Merck, GSK, and Sanofi.

Sources

1. JAMA Network Open: Mycophenolate Mofetil and New-Onset Systemic Lupus Erythematosus.
2. Market Research Intellect: Mycophenolate Mofetil Market Size, Share, Growth Drivers, and Forecast.
3. Biospace: 10 Promising IgA Nephropathy Drugs in Line to Get Approval.
4. ClinicalTrials.ucsf.edu: Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study.
5. Cognitive Market Research: Global Mycophenolate Mofetil Market Report 2024 Edition.