Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors

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NCT02228382

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Study Location
Keck Hospital of USC
Los Angeles, California, 90033, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Previously Treated PH + CML
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Participation in any other clinical studies involving investigational drug(s) within
14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to
the first dose of bosutinib.


- Prior treatment with bosutinib.


- Prior treatment with ponatinib.


- Known T315I or V299L mutation.

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Previously Treated PH + CMLSafety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
NCT02228382
  1. Los Angeles, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Deerfield Beach, Florida
  5. Miami, Florida
  6. Indianapolis, Indiana
  7. Baltimore, Maryland
  8. Creve Coeur, Missouri
  9. Saint Louis, Missouri
  10. Saint Louis, Missouri
  11. Saint Louis, Missouri
  12. New York, New York
  13. Seattle, Washington
  14. Innsbruck,
  15. Linz,
  16. Bordeaux Cedex 09,
  17. Le Chesnay Cedex,
  18. Marseille,
  19. Nice Cedex 3,
  20. Toulouse Cedex 9,
  21. Vandoeuvre-les-Nancy cedex,
  22. Aachen,
  23. Berlin,
  24. Hamburg,
  25. Jena,
  26. Koeln,
  27. Mannheim,
  28. Bari, BA
  29. Bologna, BO
  30. Monza, MB
  31. Rome, RM
  32. Orbassano, TO
  33. Catania,
  34. Firenze,
  35. Milano,
  36. Bergen,
  37. Trondheim,
  38. Pozuelo de Alarcon, Madrid
  39. Barcelona,
  40. Barcelona,
  41. Madrid,
  42. Madrid,
  43. Salamanca,
  44. Valencia,
  45. Zaragoza,
  46. Stockholm,
  47. Uppsala,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Study Of Bosutinib In Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia Previously Treated With One Or More Tyrosine Kinase Inhibitors
Official Title  ICMJE A PHASE 4 SAFETY AND EFFICACY STUDY OF BOSUTINIB (BOSULIF (REGISTERED)) IN PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA PREVIOUSLY TREATED WITH ONE OR MORE TYROSINE KINASE INHIBITORS
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Previously Treated PH + CML
Intervention  ICMJE Drug: Bosutinib
100 mg and 500 mg tablets, once daily dosage up to 4 years duration
Other Name: BOSULIF
Study Arms  ICMJE Experimental: Bosutinib
Intervention: Drug: Bosutinib
Publications * Hochhaus A, Gambacorti-Passerini C, Abboud C, Gjertsen BT, Brümmendorf TH, Smith BD, Ernst T, Giraldo-Castellano P, Olsson-Strömberg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2020)		162
Original Estimated Enrollment  ICMJE
 (submitted: August 27, 2014)		165
Actual Study Completion Date  ICMJE October 13, 2020
Actual Primary Completion Date October 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
  • 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:

  • Participation in any other clinical studies involving investigational drug(s) within 14 days or within 3 half-lives of drug levels in blood (whichever is longer) prior to the first dose of bosutinib.
  • Prior treatment with bosutinib.
  • Prior treatment with ponatinib.
  • Known T315I or V299L mutation.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Italy,   Norway,   Spain,   Sweden,   United States
Removed Location Countries Belgium,   Finland,   Netherlands
 
Administrative Information
NCT Number  ICMJE NCT02228382
Other Study ID Numbers  ICMJE B1871039
2013-003250-25 ( EudraCT Number )
BYOND ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Developmental Therapeutics Consortium
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP