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Cyclosporine

Generic Name
Cyclosporine
Brand Names
Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis
Drug Type
Small Molecule
Chemical Formula
C62H111N11O12
CAS Number
59865-13-3
Unique Ingredient Identifier
83HN0GTJ6D
Background

Cyclosporine is a calcineurin inhibitor known for its immunomodulatory properties that prevent organ transplant rejection and treat various inflammatory and autoimmune conditions. It is isolated from the fungus Beauveria nivea. Initially manufactured by Sandoz and approved for use by the FDA in 1983, cyclosporine is now available in various products by Novartis (previously known as Sandoz).

Indication

Cyclosporine is approved for a variety of conditions. Firstly, it is approved for the prophylaxis of organ rejection in allogeneic kidney, liver, and heart transplants. It is also used to prevent bone marrow transplant rejection. For the above indications, cyclosporine can be used in conjunction with azathioprine and corticosteroids. Finally, cyclosporine can be used in patients who have chronic transplant rejection and have received previous immunosuppressive therapy and to prevent or treat graft-versus-host disease (GVHD).

Secondly, cyclosporine is used for the treatment of patients with severe active rheumatoid arthritis (RA) when they no longer respond to methotrexate alone. It can be used for the treatment of adult non-immunocompromised patients with severe, recalcitrant, plaque psoriasis that have failed to respond to at least one systemic therapy or when systemic therapies are not tolerated or contraindicated. The ophthalmic solution of cyclosporine is indicated to increase tear production in patients suffering from keratoconjunctivitis sicca. In addition, cyclosporine is approved for the treatment of steroid dependent and steroid-resistant nephrotic syndrome due to glomerular diseases which may include minimal change nephropathy, focal and segmental glomerulosclerosis or membranous glomerulonephritis.

A cyclosporine ophthalmic emulsion is indicated in the treatment of vernal keratoconjunctivitis in adults and children.

Off-label, cyclosporine is commonly used for the treatment of various autoimmune and inflammatory conditions such as atopic dermatitis, blistering disorders, ulcerative colitis, juvenile rheumatoid arthritis, uveitis, connective tissue diseases, as well as idiopathic thrombocytopenic purpura.

Associated Conditions
Atopic Dermatitis, Bone Marrow Transplant Rejection, Chronic transplant rejection, Connective Tissue Disorders, Dry Eyes, Graft-versus-host Disease (GVHD), Heart Transplant Rejection, Immune Thrombocytopenia (ITP), Interstitial Cystitis, Juvenile Idiopathic Arthritis (JIA), Kidney Transplant Rejection, Liver Transplant Rejection, Lupus Nephritis, Nephrotic Syndrome, Ocular Rosacea, Rheumatoid Arthritis, Severe Ulcerative Colitis, Steroid Dependent Nephrotic Syndrome, Steroid Resistant Nephrotic Syndrome, Uveitis, Vernal Keratoconjunctivitis, Blistering disorder, Refractory Ulcerative colitis, Severe Psoriasis, Severe, active Rheumatoid arthritis, Severe, recalcitrant Plaque psoriasis, Suppressed tear production
Associated Therapies
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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

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

Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow

Phase 2
Completed
Conditions
Myelodysplastic Syndrome
Myeloproliferative Disorders
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Interventions
Procedure: T-cell replete PBPC allograft
Drug: G-CSF
Drug: Methotrexate
Drug: Cyclosporine
First Posted Date
2003-01-27
Last Posted Date
2023-09-21
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Target Recruit Count
202
Registration Number
NCT00003838
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Melphalan, Fludarabine, and Alemtuzumab Followed by Peripheral Stem Cell Transplant in Treating Patients With Hematologic Cancer

Phase 2
Completed
Conditions
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Interventions
Biological: alemtuzumab
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: melphalan
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
First Posted Date
2003-01-27
Last Posted Date
2013-01-07
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
51
Registration Number
NCT00027560
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Myeloproliferative Disorder

Phase 1
Completed
Conditions
Chronic Myeloproliferative Disorders
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
First Posted Date
2003-01-27
Last Posted Date
2010-09-16
Lead Sponsor
Fred Hutchinson Cancer Center
Target Recruit Count
30
Registration Number
NCT00049634
Locations
🇺🇸

Fred Hutchinson Cancer Research Center, Seattle, Washington, United States

🇺🇸

Seattle Cancer Care Alliance, Seattle, Washington, 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

Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

Phase 2
Completed
Conditions
Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
First Posted Date
2003-01-27
Last Posted Date
2012-03-15
Lead Sponsor
Case Comprehensive Cancer Center
Target Recruit Count
44
Registration Number
NCT00003335
Locations
🇺🇸

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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