Cyclosporine

Generic Name: Cyclosporine

Brand Names: Cequa, Gengraf, Neoral, Restasis, Sandimmune, Verkazia, Vevye, Ikervis

Drug Type: Small Molecule

Chemical Formula: C_₆₂H_₁₁₁N_₁₁O_₁₂

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

Clinical Trials

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

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

Monoclonal Antibody Therapy, Cyclosporine, and Paclitaxel in Treating Patients With Recurrent or Refractory Metastatic Breast Cancer

Phase 1

Conditions: Breast Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-20

Lead Sponsor: University of California, Davis

Registration Number: NCT00009763

Locations: 🇺🇸
University of California Davis Cancer Center, Sacramento, California, United States

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Phase 2

Completed

Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma
Contiguous Stage II Small Lymphocytic Lymphoma
Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma
Peripheral T-cell Lymphoma
Recurrent Adult Acute Myeloid Leukemia
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Lymphoblastic Lymphoma

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

First Posted Date: 2003-01-27

Last Posted Date: 2020-01-29

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 60

Registration Number: NCT00040846

Locations: 🇮🇹
University of Torino, Torino, Italy
🇺🇸
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

and more 4 locations

S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Leukemia
Myelodysplastic Syndromes

First Posted Date: 2003-01-27

Last Posted Date: 2015-03-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 130

Registration Number: NCT00016419

Locations: 🇺🇸
MBCCOP - Gulf Coast, Mobile, Alabama, United States
🇺🇸
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States

and more 91 locations

Autologous Stem Cell Transplant Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Lymphoma

Phase 1

Completed

Conditions: Recurrent Adult Hodgkin Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Recurrent Childhood Non-Hodgkin Lymphoma
Refractory Childhood Hodgkin Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
T-Cell Chronic Lymphocytic Leukemia
T-Cell Prolymphocytic Leukemia
Recurrent Childhood Hodgkin Lymphoma

Interventions: Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Drug: Cyclophosphamide
Drug: Cyclosporine
Drug: Cytarabine
Drug: Etoposide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Drug: Mycophenolate Mofetil
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Autologous 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: 76

Registration Number: NCT00005803

Locations: 🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
🇺🇸
LDS Hospital, Salt Lake City, Utah, United States
🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States

and more 2 locations

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

First Posted Date: 2003-01-27

Last Posted Date: 2023-06-22

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00014508

Locations: 🇺🇸
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
🇺🇸
Baptist Cancer Institute - Jacksonville, Jacksonville, Florida, United States

and more 9 locations