Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
NCT ID: NCT02228382
Last Updated: 2021-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
163 participants
INTERVENTIONAL
2014-11-07
2020-10-13
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
TREATMENT
NONE
Study Groups
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Bosutinib
Bosutinib
100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Interventions
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Bosutinib
100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior treatment with 1 or more tyrosine kinase inhibitor drugs (imatinib, dasatinib and/or nilotinib) for Philadelphia Chromosome positive Chronic Myeloid Leukemia (CML).
* Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
Exclusion Criteria
* Prior treatment with bosutinib.
* Prior treatment with ponatinib.
* Known T315I or V299L mutation.
18 Years
ALL
No
Sponsors
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Developmental Therapeutics Consortium
OTHER
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Keck Hospital of USC
Los Angeles, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sylvester Deerfield Beach
Deerfield Beach, Florida, United States
University of Miami Hospital & Clinics
Miami, Florida, United States
Indiana Blood and Marrow Transplantation-Clinic
Indianapolis, Indiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Weill Cornell Medical College - New York-Presbyterian Hospital
New York, New York, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Ordensklinikum Linz Gmbh Barmherzige Schwestern
Linz, , Austria
Institut Bergonie
Bordeaux, , France
Centre Hospitalier de Versailles (CHV)-Hopital Andre Mignot Service d'Hematologie Clinique- Oncology
Le Chesnay, , France
Centre Regional De Lutte Contre Le Cancer
Marseille, , France
Hopital Archet I
Nice, , France
Institut Universitaire du Cancer Toulouse - Oncopole
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
RWTH Uniklinik Aachen Klinik fur Onkologie, Hamatologie und Stammzelltransplantation
Aachen, , Germany
Charite - Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)
Berlin, , Germany
Universitaetsklinikum Koeln (AoeR)
Cologne, , Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Klinik fur Innere Medizin II
Jena, , Germany
III. Medizinische Klinik Universitaetsmedizin Mannheim
Mannheim, , Germany
AOU Policlinico Consorziale di Bari - UO Ematologia con Trapianto
Bari, BA, Italy
A.O.U. Policlinico S. Orsola-Malpighi
Bologna, BO, Italy
Azienda Socio Sanitaria Territoriale - ASST Monza
Monza, MB, Italy
Ospedale S. Eugenio - UOC Ematologia
Rome, RM, Italy
AOU San Luigi Gonzaga SCDU Medicina Interna II ad indirizzo Ematologico
Orbassano, TO, Italy
AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico
Catania, , Italy
SOD Ematologia
Florence, , Italy
A.O. Ospedale Niguarda Ca Granda - SC Ematologia
Milan, , Italy
Haukeland Universitetssjukehus
Bergen, , Norway
St Olav Hospital
Trondheim, , Norway
Hospital Universitario Quiron Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d' Hebron
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic De Barcelona
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Hospital de dia Quiron Zaragoza
Zaragoza, , Spain
Hematologiskt centrum
Stockholm, , Sweden
Akademiska Sjukhuset
Uppsala, , Sweden
Countries
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References
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Gambacorti-Passerini C, Brummendorf TH, Abruzzese E, Kelly KR, Oehler VG, Garcia-Gutierrez V, Hjorth-Hansen H, Ernst T, Leip E, Purcell S, Luscan G, Viqueira A, Giles FJ, Hochhaus A. Efficacy and safety of bosutinib in previously treated patients with chronic myeloid leukemia: final results from the BYOND trial. Leukemia. 2024 Oct;38(10):2162-2170. doi: 10.1038/s41375-024-02372-x. Epub 2024 Aug 20.
Smith BD, Brummendorf TH, Roboz GJ, Gambacorti-Passerini C, Charbonnier A, Viqueira A, Leip E, Purcell S, Goldman EH, Giles F, Ernst T, Hochhaus A, Rosti G. Efficacy and safety of bosutinib in patients treated with prior imatinib and/or dasatinib and/or nilotinib: Subgroup analyses from the phase 4 BYOND study. Leuk Res. 2024 Apr;139:107481. doi: 10.1016/j.leukres.2024.107481. Epub 2024 Mar 11.
Rosti G, Brummendorf TH, Gjertsen BT, Giraldo-Castellano P, Castagnetti F, Gambacorti-Passerini C, Ernst T, Zhao H, Kuttschreuter L, Purcell S, Giles FJ, Hochhaus A. Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study. Leukemia. 2024 Jan;38(1):126-135. doi: 10.1038/s41375-023-02080-y. Epub 2023 Nov 25.
Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.
Hochhaus A, Gambacorti-Passerini C, Abboud C, Gjertsen BT, Brummendorf TH, Smith BD, Ernst T, Giraldo-Castellano P, Olsson-Stromberg U, Saussele S, Bardy-Bouxin N, Viqueira A, Leip E, Russell-Smith TA, Leone J, Rosti G, Watts J, Giles FJ; BYOND Study Investigators. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study. Leukemia. 2020 Aug;34(8):2125-2137. doi: 10.1038/s41375-020-0915-9. Epub 2020 Jun 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-003250-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BYOND
Identifier Type: OTHER
Identifier Source: secondary_id
B1871039
Identifier Type: -
Identifier Source: org_study_id