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

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

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

Total-Body Irradiation and Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Phase 1

Completed

Conditions: Adult Acute Myeloid Leukemia in Remission
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood Acute Myeloid Leukemia in Remission
Childhood Myelodysplastic Syndrome
Childhood Renal Cell Carcinoma
Chronic Myelomonocytic Leukemia
Clear Cell Renal Cell Carcinoma
de Novo Myelodysplastic Syndrome
Metastatic Renal Cell Cancer
Previously Treated Myelodysplastic Syndrome

Interventions: Drug: Fludarabine Phosphate
Radiation: Total-Body Irradiation
Procedure: Peripheral Blood Stem Cell Transplantation
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclosporine
Drug: Mycophenolate Mofetil

First Posted Date: 2003-01-27

Last Posted Date: 2019-12-20

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 106

Registration Number: NCT00027820

Locations: 🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States
🇺🇸
University of Arizona Health Sciences Center, Tucson, Arizona, United States
🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States

and more 7 locations

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