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Last Updated: December 26, 2024

CLINICAL TRIALS PROFILE FOR SIMULECT


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Biosimilar Clinical Trials for SIMULECT

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT04871607 ↗ Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma Recruiting National Cancer Institute (NCI) Phase 2 2021-11-01 This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
NCT04871607 ↗ Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma Recruiting City of Hope Medical Center Phase 2 2021-11-01 This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for SIMULECT

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00023244 ↗ Steroid Withdrawal in Pediatric Kidney Transplant Recipients Terminated Cooperative Clinical Trials in Pediatric Transplantation Phase 2 2001-01-01 The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
NCT00023244 ↗ Steroid Withdrawal in Pediatric Kidney Transplant Recipients Terminated National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2001-01-01 The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
NCT00101738 ↗ Freedom Study: Myfortic in Kidney Transplant Patients Completed Novartis Pharmaceuticals Phase 3 2003-03-01 The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
NCT00113269 ↗ Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients Completed Astellas Pharma Inc Phase 4 2005-05-01 The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
NCT00154284 ↗ Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients Completed Novartis Phase 3 2005-07-01 The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.
NCT00188825 ↗ Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant Completed Novartis Phase 3 2004-05-01 The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
NCT00188825 ↗ Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant Completed University Health Network, Toronto Phase 3 2004-05-01 The study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SIMULECT

Condition Name

Condition Name for SIMULECT
Intervention Trials
Kidney Transplantation 12
Renal Transplantation 4
Liver Transplantation 3
Renal Transplant Rejection 2
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Condition MeSH

Condition MeSH for SIMULECT
Intervention Trials
Kidney Failure, Chronic 5
Leukemia 3
Hodgkin Disease 3
Leukemia, Myeloid, Acute 3
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Clinical Trial Locations for SIMULECT

Trials by Country

Trials by Country for SIMULECT
Location Trials
United States 140
Canada 15
United Kingdom 13
Germany 11
France 9
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Trials by US State

Trials by US State for SIMULECT
Location Trials
California 12
Pennsylvania 9
Illinois 8
Texas 8
Ohio 8
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Clinical Trial Progress for SIMULECT

Clinical Trial Phase

Clinical Trial Phase for SIMULECT
Clinical Trial Phase Trials
Phase 4 23
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for SIMULECT
Clinical Trial Phase Trials
Completed 36
Terminated 7
Unknown status 4
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Clinical Trial Sponsors for SIMULECT

Sponsor Name

Sponsor Name for SIMULECT
Sponsor Trials
Novartis Pharmaceuticals 10
Novartis 8
Astellas Pharma Inc 6
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Sponsor Type

Sponsor Type for SIMULECT
Sponsor Trials
Other 57
Industry 39
NIH 10
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