FN-1501

Generic Name: FN-1501

Brand Names: Cellcept, Myfenax, CellCept, Mycophenolate mofetil Teva, Myclausen

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₅N_₉O

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

Clinical Trials

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

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

Combination Chemotherapy Followed by Donor Bone Marrow Transplant or Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer or Genetic Disorders

Phase 2

Conditions: Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes

First Posted Date: 2003-01-27

Last Posted Date: 2014-01-06

Lead Sponsor: Herbert Irving Comprehensive Cancer Center

Target Recruit Count: 52

Registration Number: NCT00008307

Locations: 🇺🇸
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States

Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

Phase 2

Terminated

Conditions: Leukemia
Lymphoma

First Posted Date: 2003-01-27

Last Posted Date: 2020-04-10

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 10

Registration Number: NCT00041288

Locations: 🇺🇸
Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
🇺🇸
Simmons Cancer Center - Dallas, Dallas, Texas, United States
🇺🇸
University of Missouri Kansas City School of Medicine, Kansas City, Missouri, United States

and more 20 locations

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

Phase 2

Completed

Conditions: Recurrent Adult Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Blastic Phase
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Disease
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Phase of Disease

Interventions: Drug: Cyclosporine
Drug: Dasatinib
Drug: Fludarabine Phosphate
Drug: Imatinib Mesylate
Drug: Mycophenolate Mofetil
Drug: Nilotinib
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Radiation: Total-Body Irradiation

First Posted Date: 2003-01-27

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 28

Registration Number: NCT00036738

Locations: 🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States

Reduced Intensity Donor Peripheral Blood Stem Cell Transplant in Treating Patients With De Novo or Secondary Acute Myeloid Leukemia in Remission

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Secondary Acute Myeloid Leukemia
Adult Acute Myeloblastic Leukemia Without Maturation (M1)

Interventions: Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Drug: fludarabine phosphate
Radiation: total-body irradiation
Drug: cyclosporine
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation

First Posted Date: 2003-01-27

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 17

Registration Number: NCT00045435

Locations: 🇺🇸
OHSU Cancer Institute, Portland, Oregon, United States
🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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

Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

Phase 2

Completed

Conditions: Cervical Cancer
Vaginal Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2010-04-02

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT00005941

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

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