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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR SIROLIMUS

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Clinical Trials for Sirolimus

Trial ID Title Status Sponsor Phase Summary
NCT00001984 Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits the NFkB pathway thus preventing monocyte and macrophage activation. Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H prior to transplantation to insure that peripheral depletion is achieved at the time of graft reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third and fifth days after the transplant to deplete passenger donor leukocytes and residual recipient cells that mobilize in response to the allograft. In addition, patients will be treated with DSG for 14 days beginning on the day prior to surgery. This trial expands on pilot studies at the NIH of 15 patients in which Campath was given alone at the time of transplantation. In those studies, excellent peripheral depletion occurred after just one dose of Campath though central depletion required additional dosing. This allowed for greatly reduced immunosuppression to be used to prevent rejection, but to date, all patients have required some immunosuppressive medication. It is hoped that the addition of DSG will eliminate the need for long-term immunosuppression. Patients will be followed closely in the post transplant period. If patients experience rejection, they will be treated with methylprednisolone and have immunosuppression added using sirolimus as the predominant immunosuppressive agent. In the previous phase of this study without DSG, this maneuver has in all cases been successful in returning the allograft to normal function. In addition to evaluating graft function following transplantation, this protocol will also characterize and evaluate the function of the immune system and the composition of the T cell repertoire following the administration of Campath-1H and DSG, and during immune system recovery after transplantation.
NCT00002790 Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant Withdrawn National Cancer Institute (NCI) Phase 1/Phase 2 RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate, and cyclosporine may prevent this from happening. PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant.
NCT00002790 Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant Withdrawn Fred Hutchinson Cancer Research Center Phase 1/Phase 2 RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate, and cyclosporine may prevent this from happening. PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Sirolimus

Condition Name

Condition Name for Sirolimus
Intervention Trials
Kidney Transplantation 43
Leukemia 22
Lymphoma 18
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Condition MeSH

Condition MeSH for Sirolimus
Intervention Trials
Graft vs Host Disease 53
Leukemia 48
Preleukemia 31
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Clinical Trial Locations for Sirolimus

Trials by Country

Trials by Country for Sirolimus
Location Trials
United States 836
Canada 46
Germany 29
Spain 28
Belgium 26
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Trials by US State

Trials by US State for Sirolimus
Location Trials
Maryland 68
California 66
Florida 49
Massachusetts 48
Pennsylvania 46
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Clinical Trial Progress for Sirolimus

Clinical Trial Phase

Clinical Trial Phase for Sirolimus
Clinical Trial Phase Trials
Phase 4 95
Phase 3 50
Phase 2/Phase 3 16
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Clinical Trial Status

Clinical Trial Status for Sirolimus
Clinical Trial Phase Trials
Completed 212
Recruiting 113
Active, not recruiting 46
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Clinical Trial Sponsors for Sirolimus

Sponsor Name

Sponsor Name for Sirolimus
Sponsor Trials
National Cancer Institute (NCI) 74
Wyeth is now a wholly owned subsidiary of Pfizer 43
National Institute of Allergy and Infectious Diseases (NIAID) 21
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Sponsor Type

Sponsor Type for Sirolimus
Sponsor Trials
Other 542
Industry 178
NIH 151
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Boehringer Ingelheim
McKesson
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UBS
Cipla

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