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Trial record 8 of 51 for:    bosutinib

A Study To Describe The Real World Use Of Bosutinib In The UK And Netherlands

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ClinicalTrials.gov Identifier: NCT02546375
Recruitment Status : Completed
First Posted : September 10, 2015
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
pH Associates
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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

Condition or disease Intervention/treatment
Chronic Myeloid Leukaemia Drug: Bosutinib

Study Type : Observational
Actual Enrollment : 87 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Retrospective Observational Research Study To Describe The Real World Use Of Bosutinib In The Uk And Netherlands
Actual Study Start Date : July 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017


Group/Cohort Intervention/treatment
Chronic Myeloid Leukaemia
Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib
Drug: Bosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
Other Name: Bosulif




Primary Outcome Measures :
  1. Percentage of Participants With Cumulative Complete Haematological Response (CHR) [ Time Frame: Baseline up to 5.5 years ]
    Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (<) 450*10^9 per liter, white blood cells count <10*10^9 per liter, no immature granulocytes and <5 percent (%) basophils on differential and a non-palpable spleen.

  2. Percentage of Participants With Cumulative Partial Haematological Response (PHR) [ Time Frame: Baseline up to 5.5 years ]
    Haematological response used blood sample of the participants to evaluate response to treatment for CML.

  3. Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) [ Time Frame: Baseline up to 5.5 years ]
    Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei.

  4. Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) [ Time Frame: Baseline up to 5.5 years ]
    CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases.

  5. Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) [ Time Frame: Baseline up to 5.5 years ]
    CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases.

  6. Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) [ Time Frame: Baseline up to 5.5 years ]
    CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases.

  7. Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) [ Time Frame: Baseline up to 5.5 years ]
    Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with <0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.

  8. Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) [ Time Frame: Baseline up to 5.5 years ]
    Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with <0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with >32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.

  9. Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) [ Time Frame: Baseline up to 5.5 years ]
    Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (<=) 0.1% on the IS.


Secondary Outcome Measures :
  1. Percentage of Participants With Treatment Related Adverse Events (AEs) [ Time Frame: Baseline up to 5.5 years ]
    Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator.

  2. Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 [ Time Frame: Baseline up to 5.5 years ]
    Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.

  3. Progression-free Survival (PFS) [ Time Frame: Year 1, 2, 3 ]
    PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection.

  4. Overall Survival (OS) [ Time Frame: From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3 ]
    OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively.

  5. Percentage of Participants With Disease Progression [ Time Frame: Year 1, 2, 3 ]
    Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with <10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes >30%, with blasts <30% in blood or bone marrow, platelet count <100*10^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow >=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy.

  6. Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy [ Time Frame: Baseline up to 5.5 years ]
  7. Cross-Intolerance Between Bosutinib and Previous Therapy [ Time Frame: Baseline up to 5.5 years ]
    Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib).

  8. Mean Dose of Bosutinib at Initiation of Treatment [ Time Frame: Baseline up to 5.5 years ]
  9. Relative Bosutinib Dose Intensity [ Time Frame: Baseline up to 5.5 years ]
    Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug.

  10. Duration of Bosutinib Therapy [ Time Frame: Baseline up to 5.5 years ]
    The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CML out-patient clinics
Criteria

Inclusion Criteria:

  • Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation.
  • Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 OR via the compassionate use programme prior to marketing authorization.
  • Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Prescribed bosutinib as part of an interventional clinical trial programme.
  • Initiated on bosutinib less than 3 months prior to data collection taking place.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546375


Locations
United Kingdom
Royal Liverpool Hospital
Liverpool, Merseyside, United Kingdom, L7 8XP
Hammersmith Hospital
London, United Kingdom, W12 0HS
Nottingham University Hospital
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Pfizer
pH Associates
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02546375     History of Changes
Other Study ID Numbers: B1871052
First Posted: September 10, 2015    Key Record Dates
Results First Posted: September 13, 2018
Last Update Posted: September 13, 2018
Last Verified: December 2017

Keywords provided by Pfizer:
Bosutinib
chronic myeloid leukaemia
retrospective
observational

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases