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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR SANDIMMUNE

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Clinical Trials for Sandimmune

Trial ID Title Status Sponsor Phase Summary
NCT00000936 A Study To Test An Anti-Rejection Therapy After Kidney Transplantation Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 Kidney transplantation is often successful. However, despite aggressive anti-rejection drug therapy, some patients will reject their new kidney. This study is designed to test two anti-rejection approaches. Two medications in this study are currently used in children, but there is no information regarding which drug is safer or more effective. Survival rates in renal transplantation are unacceptably low. Therefore, there is a need for an improved post-transplant treatment, such as the induction therapy used in this study.
NCT00428064 Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus versus induction with CsA and sirolimus followed by CsA elimination and concentration-controlled sirolimus.
NCT00520468 Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS Completed M.D. Anderson Cancer Center Phase 2 Objectives: Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk myelodysplastic syndromes (MDS). Secondary: To evaluate response duration, survival and side effects of the treatment.
NCT00840827 Study of the Efficacy and Safety of Lenalidomide in Combination With Cyclosporine A in Patients With Myelodysplastic Syndromes Completed Celgene Corporation Phase 2 Lenalidomide has shown significant efficacy in the treatment of anemia associated with both 5q- and non 5q- MDS patients. The mechanism(s) of action of lenalidomide in MDS is still to be determined, but given the differences in response rates seen, it is probable that the mechanism is different for patients with 5q- disease compared to non 5q- patients. T-cell mediated activation of intramedullary apoptosis in patients with early MDS leading to impaired hematopoiesis has been well described. Immunomodulation with agents such as ATG, cyclosporine and thalidomide have demonstrated clear activity in some patients with MDS. Lenalidomide, among its many effects, is a potent immunomodulator, which may contribute to its ability to improve red blood cell counts in patients with MDS. It is possible that this effect could be augmented with the addition of cyclosporine A (CSA), in a similar manner to CSA effects in patients with other bone marrow failure syndromes such as aplastic anemia. Subjects will be treated with lenalidomide 10 mg PO daily days 1-28 of a 28-day cycle. Cyclosporine A will be started on day 1 of cycle 2 (day 29) at a dose of 5 mg/kg per day given orally in 2 divided doses. Cyclosporine A levels will be assessed weekly and doses will be adjusted to maintain a serum trough level between 100-450 mg/ml. Patients will continue on therapy for minimum of 16 weeks unless toxicity occurs which precludes continuation on therapy, disease progression and/or patient withdrawal of consent. Patients not achieving response after completing 16 weeks of therapy will discontinue treatment. Patients achieving response will continue therapy until disease progression, unacceptable toxicity or loss of response.
NCT00840827 Study of the Efficacy and Safety of Lenalidomide in Combination With Cyclosporine A in Patients With Myelodysplastic Syndromes Completed Weill Medical College of Cornell University Phase 2 Lenalidomide has shown significant efficacy in the treatment of anemia associated with both 5q- and non 5q- MDS patients. The mechanism(s) of action of lenalidomide in MDS is still to be determined, but given the differences in response rates seen, it is probable that the mechanism is different for patients with 5q- disease compared to non 5q- patients. T-cell mediated activation of intramedullary apoptosis in patients with early MDS leading to impaired hematopoiesis has been well described. Immunomodulation with agents such as ATG, cyclosporine and thalidomide have demonstrated clear activity in some patients with MDS. Lenalidomide, among its many effects, is a potent immunomodulator, which may contribute to its ability to improve red blood cell counts in patients with MDS. It is possible that this effect could be augmented with the addition of cyclosporine A (CSA), in a similar manner to CSA effects in patients with other bone marrow failure syndromes such as aplastic anemia. Subjects will be treated with lenalidomide 10 mg PO daily days 1-28 of a 28-day cycle. Cyclosporine A will be started on day 1 of cycle 2 (day 29) at a dose of 5 mg/kg per day given orally in 2 divided doses. Cyclosporine A levels will be assessed weekly and doses will be adjusted to maintain a serum trough level between 100-450 mg/ml. Patients will continue on therapy for minimum of 16 weeks unless toxicity occurs which precludes continuation on therapy, disease progression and/or patient withdrawal of consent. Patients not achieving response after completing 16 weeks of therapy will discontinue treatment. Patients achieving response will continue therapy until disease progression, unacceptable toxicity or loss of response.
NCT01659606 Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita Recruiting Boston Children’s Hospital Phase 2 Dyskeratosis congenita is a disease that affects numerous parts of the body, most typically causing failure of the blood system. Lung disease and a predisposition to cancer are also frequent causes of illness and death. Bone marrow transplantation (BMT) can cure the blood system but can make the lung disease and cancer predisposition worse, because of agents such as alkylators and radiation that are typically used in the procedure. Based on the biology of DC, we hypothesize that it may be possible to avoid these agents in patients with DC, and still have a successful BMT. In this protocol we will test whether a regimen that avoids alkylators and radiation can permit successful BMT without compromising survival in patients with DC.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sandimmune

Condition Name

Condition Name for Sandimmune
Intervention Trials
Myelodysplastic Syndrome 4
Recurrent Hodgkin Lymphoma 3
Acute Lymphoblastic Leukemia 2
Chronic Myelomonocytic Leukemia 2
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Condition MeSH

Condition MeSH for Sandimmune
Intervention Trials
Preleukemia 6
Myelodysplastic Syndromes 6
Syndrome 6
Leukemia, Myeloid, Acute 4
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Clinical Trial Locations for Sandimmune

Trials by Country

Trials by Country for Sandimmune
Location Trials
United States 10
Italy 1
Czech Republic 1
Austria 1
China 1
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Trials by US State

Trials by US State for Sandimmune
Location Trials
Washington 3
New York 3
California 1
Massachusetts 1
Texas 1
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Clinical Trial Progress for Sandimmune

Clinical Trial Phase

Clinical Trial Phase for Sandimmune
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 8
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Clinical Trial Status

Clinical Trial Status for Sandimmune
Clinical Trial Phase Trials
Completed 6
Recruiting 6
Not yet recruiting 4
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Clinical Trial Sponsors for Sandimmune

Sponsor Name

Sponsor Name for Sandimmune
Sponsor Trials
National Cancer Institute (NCI) 4
Fred Hutchinson Cancer Research Center 3
Brooke Army Medical Center 1
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Sponsor Type

Sponsor Type for Sandimmune
Sponsor Trials
Other 17
NIH 5
Industry 4
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