MedPath

FN-1501

Generic Name
FN-1501
Brand Names
Cellcept, Myfenax, CellCept, Mycophenolate mofetil Teva, Myclausen
Drug Type
Small Molecule
Chemical Formula
C22H25N9O
CAS Number
1429515-59-2
Unique Ingredient Identifier
6MC966B505
Background

Mycophenolate mofetil, also known as MMF or CellCept, is a prodrug of mycophenolic acid, and classified as a reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). This drug is an immunosuppressant combined with drugs such as Cyclosporine and corticosteroids to prevent organ rejection after hepatic, renal, and cardiac transplants. It is marketed by Roche Pharmaceuticals and was granted FDA approval for the prophylaxis of transplant rejection in 1995. In addition to the above uses, mycophenolate mofetil has also been studied for the treatment of nephritis and other complications of autoimmune diseases. Unlike another immunosuppressant class, the calcineurin inhibitors, MMF generally does not cause nephrotoxicity or fibrosis.

Previously, mycophenolic acid (MPA) was administered to individuals with autoimmune diseases beginning in the 1970s, but was discontinued due to gastrointestinal effects and concerns over carcinogenicity. The new semi-synthetic 2-morpholinoethyl ester of MPA was synthesized to avoid the gastrointestinal effects associated with the administration of MPA. It demonstrates an increased bioavailability, a higher efficacy, and reduced gastrointestinal effects when compared to MPA.

Indication

Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old. Mycophenolate mofetil may also be used off-label as a second-line treatment for autoimmune hepatitis that has not responded adequately to first-line therapy. Other off-label uses of this drug include lupus-associated nephritis and dermatitis in children.

Associated Conditions
Transplanted Organ Rejection
Associated Therapies
-

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 1
Completed
Conditions
Refractory Multiple Myeloma
Interventions
Drug: fludarabine phosphate
Drug: melphalan
Radiation: total-body irradiation
Drug: mycophenolate mofetil
Drug: cyclosporine
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Other: laboratory biomarker analysis
First Posted Date
2003-02-06
Last Posted Date
2017-10-16
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
16
Registration Number
NCT00054353
Locations
🇮🇹

University of Torino, Torino, Italy

🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders

Phase 2
Completed
Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Chronic Myeloproliferative Disorders
Fanconi Anemia
Aplastic Anemia
Leukemia
Lymphoma
Interventions
Biological: anti-thymocyte globulin
Biological: graft-versus-tumor induction therapy
Biological: sargramostim
Biological: therapeutic allogeneic lymphocytes
Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: methylprednisolone
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
First Posted Date
2003-02-06
Last Posted Date
2020-02-10
Lead Sponsor
Roswell Park Cancer Institute
Target Recruit Count
41
Registration Number
NCT00053989
Locations
🇺🇸

Roswell Park Cancer Institute, Buffalo, New York, United States

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Cancer

Phase 2
Completed
Conditions
Leukemia
Lymphoma
Multiple Myeloma
Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myeloproliferative Neoplasms
Interventions
Biological: anti-thymocyte globulin
Biological: G-CSF
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic cell transplantation
Drug: allopurinol
First Posted Date
2003-01-28
Last Posted Date
2016-07-01
Lead Sponsor
Alliance for Clinical Trials in Oncology
Target Recruit Count
82
Registration Number
NCT00053196
Locations
🇺🇸

Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, United States

🇺🇸

Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

🇺🇸

Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Voorhees, New Jersey, United States

and more 9 locations

S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

Phase 2
Terminated
Conditions
Leukemia
Interventions
Biological: therapeutic allogeneic lymphocytes
Drug: cyclosporine
Drug: fludarabine
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
First Posted Date
2003-01-28
Last Posted Date
2015-03-25
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
5
Registration Number
NCT00053014
Locations
🇺🇸

CCOP - Atlanta Regional, Atlanta, Georgia, United States

🇺🇸

University of Mississippi Medical Center, Jackson, Mississippi, United States

🇺🇸

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States

and more 80 locations

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

Phase 2
Completed
Conditions
Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Disease
Accelerated Phase of Disease
Chronic Phase of Disease
Interventions
Drug: Fludarabine Phosphate
Radiation: Total-Body Irradiation
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Drug: Cyclosporine
Drug: Mycophenolate Mofetil
Biological: Therapeutic Allogeneic Lymphocytes
Other: Laboratory Biomarker Analysis
First Posted Date
2003-01-27
Last Posted Date
2020-01-10
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
18
Registration Number
NCT00003145
Locations
🇺🇸

Baylor University Medical Center, Dallas, Texas, United States

🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Stanford University Hospitals and Clinics, Stanford, California, United States

and more 5 locations

Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Kidney Cancer

Phase 2
Withdrawn
Conditions
Kidney Cancer
First Posted Date
2003-01-27
Last Posted Date
2013-07-11
Lead Sponsor
Fox Chase Cancer Center
Registration Number
NCT00025519

Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Phase 2
Completed
Conditions
Multiple Myeloma and Plasma Cell Neoplasm
Leukemia
Myelodysplastic Syndromes
Lymphoma
Myelodysplastic/Myeloproliferative Diseases
First Posted Date
2003-01-27
Last Posted Date
2019-09-17
Lead Sponsor
University of Texas Southwestern Medical Center
Registration Number
NCT00044954
Locations
🇺🇸

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, United States

🇺🇸

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States

🇺🇸

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States

and more 11 locations

Fludarabine Phosphate and Total-Body Radiation Followed by Donor Peripheral Blood Stem Cell Transplant and Immunosuppression in Treating Patients With Hematologic Malignancies

Not Applicable
Completed
Conditions
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Childhood Myelodysplastic Syndromes
Childhood Nasal Type Extranodal NK/T-cell Lymphoma
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Adult Nasal Type Extranodal NK/T-cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Acute Undifferentiated Leukemia
Interventions
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2020-01-21
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
160
Registration Number
NCT00014235
Locations
🇺🇸

University of Arizona Health Sciences Center, Tucson, Arizona, United States

🇺🇸

Baylor University Medical Center, Dallas, Texas, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

and more 8 locations

Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission

Phase 2
Completed
Conditions
Adult Acute Lymphoblastic Leukemia in Remission
Childhood Acute Lymphoblastic Leukemia in Remission
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Interventions
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Biological: donor lymphocytes
Drug: cyclosporine
Radiation: total-body irradiation
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis
Procedure: peripheral blood stem cell transplantation
First Posted Date
2003-01-27
Last Posted Date
2012-12-07
Lead Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Target Recruit Count
30
Registration Number
NCT00031655
Locations
🇺🇸

Veterans Affairs Puget Sound Healthcare System, Seattle, Washington, United States

🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Oregon Health and Sciences University, Portland, Oregon, United States

Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Stage IV Kidney Cancer

Phase 1
Completed
Conditions
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Biological: therapeutic allogeneic lymphocytes
Other: laboratory biomarker analysis
First Posted Date
2003-01-27
Last Posted Date
2019-07-24
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
11
Registration Number
NCT00005851
Locations
🇺🇸

Rocky Mountain Cancer Centers-Aurora, Aurora, Colorado, United States

🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

🇺🇸

Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

and more 3 locations
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