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Last Updated: December 5, 2019

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CLINICAL TRIALS PROFILE FOR BOSULIF

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All Clinical Trials for Bosulif

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02228382 Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors Recruiting Developmental Therapeutics Consortium Phase 4 2014-11-01 The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).
NCT02228382 Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors Recruiting Pfizer Phase 4 2014-11-01 The purpose of this study is to fulfill the post-authorization commitment made by Pfizer to the European Medicines Agency in providing additional safety and efficacy data in approximately 150 Philadelphia Chromosome Positive Chronic Myeloid Leukemia patients with high unmet medical need, including 75 Chronic Phase, Accelerated Phase or Blast Phase patients in the fourth or later line treatment setting (i.e., after treatment with at least 3 other Tyrosine Kinase Inhibitors).
NCT02501330 Safety And Efficacy Of Bosutinib Active, not recruiting Pfizer N/A 2015-07-01 The objective of this surveillance is to collect information about 1. adverse drug reaction not expected from the LPD (unknown adverse drug reaction) 2. the incidence of adverse drug reactions in this surveillance 3. factors considered to affect the safety and/or efficacy of this drug.
NCT02546375 A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands Active, not recruiting pH Associates N/A 2015-07-01 The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
NCT02546375 A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands Active, not recruiting Pfizer N/A 2015-07-01 The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
NCT02638467 Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy Recruiting IRCCS San Raffaele Phase 2 2015-11-01 Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias that limit TKI adequate administration. Although rare, this event happens in a proportion of 4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant procedure is therefore intended in providing a sustained hematopoiesis that will allow an early treatment with an adequate dosing of TKI. The transplant procedure planned in our study is built on all available evidences to provide the lowest incidence of acute and chronic GvHD (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will be used according to standard current experience in the field of family and unrelated donors. The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as post-transplant therapy is justified by the lack of Kit inhibition that distinguishes bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against the transplanted normal bone marrow.
NCT02638467 Allogeneic Stem Cell Transplantation in Chronic Myeloid Leukemia Failing TKIs Therapy Recruiting University of Milano Bicocca Phase 2 2015-11-01 Patients newly diagnosed with chronic phase chronic myeloid leukemia undergo treatment with TK inhibitors (TKI). A possible cause of TK failure is represented by the insufficient recovery of normal Ph- hematopoiesis during TKI treatment, with consequent severe cytopenias that limit TKI adequate administration. Although rare, this event happens in a proportion of 4-5% of CML patients. Our hypothesis is to circumvent this peculiar condition by providing a normal hematopoiesis from a HLA-matched donor (Human Leukocyte Antigen). The transplant procedure is therefore intended in providing a sustained hematopoiesis that will allow an early treatment with an adequate dosing of TKI. The transplant procedure planned in our study is built on all available evidences to provide the lowest incidence of acute and chronic GvHD (Graft-versus-host disease). Therefore, a bone marrow will be the preferential source and a GvHD prophylaxis based on Anti-thrombocyte globulin (ATG) and Cyclosporine/Methotrexate will be used according to standard current experience in the field of family and unrelated donors. The pre-transplant TKI will be continued until aplasia will develop, in order to decrease the tumor load as much as possible.The use of TKIs shortly after transplant carries the risk of inhibiting the newly transplanted hematopoietic cells, as Kit, an important kinase in normal bone marrow cells, is frequently blocked by Abl inhibitors. The use of bosutinib as post-transplant therapy is justified by the lack of Kit inhibition that distinguishes bosutinib from all other TKIs, and which could allow a minimal inhibitory activity against the transplanted normal bone marrow.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Bosulif

Condition Name

Condition Name for Bosulif
Intervention Trials
Lymphoma, Non-Hodgkin 1
Chronic Myelogenous Leukemia 1
Leukemia 1
Previously Treated PH + CML 1
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Condition MeSH

Condition MeSH for Bosulif
Intervention Trials
Leukemia, Myeloid 4
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 4
Dementia 2
Leukemia 2
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Clinical Trial Locations for Bosulif

Trials by Country

Trials by Country for Bosulif
Location Trials
United States 22
Italy 11
Spain 3
Austria 2
United Kingdom 2
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Trials by US State

Trials by US State for Bosulif
Location Trials
Washington 2
California 2
District of Columbia 2
Michigan 2
Indiana 1
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Clinical Trial Progress for Bosulif

Clinical Trial Phase

Clinical Trial Phase for Bosulif
Clinical Trial Phase Trials
Phase 4 1
Phase 2 3
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Bosulif
Clinical Trial Phase Trials
Recruiting 4
Active, not recruiting 2
Not yet recruiting 1
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Clinical Trial Sponsors for Bosulif

Sponsor Name

Sponsor Name for Bosulif
Sponsor Trials
Pfizer 6
Georgetown University 2
pH Associates 1
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Sponsor Type

Sponsor Type for Bosulif
Sponsor Trials
Industry 12
Other 9
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