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 markete...

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-l...

Associated Conditions: Transplanted Organ Rejection

Associated Therapies: -

Clinical Trials

Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

Not Applicable

Terminated

Conditions: Cardiac Transplantation

First Posted Date: 2005-09-14

Last Posted Date: 2013-11-21

Lead Sponsor: Emory University

Target Recruit Count: 30

Registration Number: NCT00166153

Locations: 🇺🇸
Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens

Phase 3

Completed

Conditions: Heart Diseases
Heart Transplantation

Interventions: Drug: Tacrolimus
Drug: Cyclosporine
Drug: Mycophenolate mofetil
Drug: Methylprednisolone
Drug: Prednisone

First Posted Date: 2005-09-12

Last Posted Date: 2017-06-05

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 111

Registration Number: NCT00157014

Reduction of Tacrolimus Dose in Association With Mycophenolate Mofetil After Liver Transplantation

Phase 3

Terminated

Conditions: Evidence of Liver Transplantation

Interventions: Drug: Mycophenolate mofetil
Drug: Tacrolimus

First Posted Date: 2005-09-09

Last Posted Date: 2012-07-04

Lead Sponsor: Rennes University Hospital

Target Recruit Count: 195

Registration Number: NCT00151632

Locations: 🇫🇷
Service de Chirurgie Digestive - Hôpital de la Côte de Nacre, Caen, France
🇫🇷
Service d'Hépatogastroentérologie - Hôpital Beaujon, Clichy, France
🇫🇷
Service d'Hépatogastroentérologie - Hôpital Henri Mondor, Créteil, France

and more 5 locations

Th1, Th2 and Monokine Responses as Risk Factors of Renal Transplant Rejection

Completed

Conditions: Renal Failure, Chronic

First Posted Date: 2005-09-08

Last Posted Date: 2007-05-10

Lead Sponsor: University of Giessen

Target Recruit Count: 84

Registration Number: NCT00150891

Locations: 🇩🇪
Department of Internal Medicine, University of Giessen, Giessen, Germany

Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)

Phase 2

Completed

Conditions: Graft Vs Host Disease

Interventions: Drug: Prochymal® - 2 Million cells/kg
Drug: Prochymal®- 8 Million cells/kg
Drug: Methylprednisolone
Drug: Prednisone
Drug: Cyclosporine
Drug: Tacrolimus
Drug: Mycophenolate Mofetil

First Posted Date: 2005-08-29

Last Posted Date: 2022-01-31

Lead Sponsor: Mesoblast, Inc.

Target Recruit Count: 32

Registration Number: NCT00136903

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
St. Francis Hospital, Indianapolis, Indiana, United States
🇺🇸
New York Medical College, Valhalla, New York, United States

and more 6 locations

Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer

Phase 2

Completed

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

Interventions: Drug: cyclophosphamide
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Drug: tacrolimus
Procedure: allogeneic bone marrow transplantation
Radiation: radiation therapy

First Posted Date: 2005-08-24

Last Posted Date: 2015-10-06

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 210

Registration Number: NCT00134004

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
🇺🇸
Blood and Marrow Transplant Program at Northside Hospital, Atlanta, Georgia, United States
🇺🇸
Hahnemann University Hospital, Philadelphia, Pennsylvania, United States

Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Phase 4

Terminated

Conditions: Kidney Transplantation

Interventions: Drug: Tacrolimus
Drug: mycophenolate mofetil
Drug: Prednisone

First Posted Date: 2005-08-23

Last Posted Date: 2014-09-08

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 85

Registration Number: NCT00133172

Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 2

Terminated

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Chronic Myelomonocytic Leukemia
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts in Transformation
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Childhood Myelodysplastic Syndromes
Recurrent Childhood Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)

Interventions: Radiation: iodine I 131 monoclonal antibody BC8
Drug: fludarabine phosphate
Radiation: total-body irradiation
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Drug: cyclosporine
Drug: mycophenolate mofetil
Other: laboratory biomarker analysis

First Posted Date: 2005-07-13

Last Posted Date: 2022-12-12

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 18

Registration Number: NCT00119366

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

Yttrium Y 90 Ibritumomab Tiuxetan, Fludarabine, Radiation Therapy, and Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Recurrent Mantle Cell Lymphoma
B-cell Chronic Lymphocytic Leukemia
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma

Interventions: Biological: rituximab
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Radiation: yttrium Y 90 ibritumomab tiuxetan
Procedure: peripheral blood stem cell transplantation
Procedure: allogeneic hematopoietic stem cell transplantation
Radiation: total-body irradiation

First Posted Date: 2005-07-13

Last Posted Date: 2018-06-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 42

Registration Number: NCT00119392

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

Fludarabine, Total-Body Irradiation, and Donor Stem Cell Transplant Followed By Cyclosporine and Mycophenolate Mofetil in Treating Patients With Chronic Myelogenous Leukemia

Phase 1

Completed

Conditions: Leukemia

First Posted Date: 2005-07-13

Last Posted Date: 2010-09-21

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 75

Registration Number: NCT00119340

Locations: 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States

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