NCT02546375

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

1.5 years

First QC Date

August 26, 2015

Results QC Date

December 15, 2017

Last Update Submit

September 29, 2023

Conditions

Chronic Myeloid Leukaemia

Keywords

Bosutinibchronic myeloid leukaemiaretrospectiveobservational

Outcome Measures

Primary Outcomes (9)

  • Percentage of Participants With Cumulative Complete Haematological Response (CHR)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Partial Haematological Response (PHR)

    Haematological response used blood sample of the participants to evaluate response to treatment for CML.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)

    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.

    Baseline up to 5.5 years

  • Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)

    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.

    Baseline up to 5.5 years

Secondary Outcomes (10)

  • Percentage of Participants With Treatment Related Adverse Events (AEs)

    Baseline up to 5.5 years

  • Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3

    Baseline up to 5.5 years

  • Progression-free Survival (PFS)

    Year 1, 2, 3

  • Overall Survival (OS)

    From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3

  • Percentage of Participants With Disease Progression

    Year 1, 2, 3

  • +5 more secondary outcomes

Study Arms (1)

Chronic Myeloid Leukaemia

Patients diagnosed with chronic myeloid leukaemia treated with Bosutinib

Drug: Bosutinib

Interventions

BosutinibDRUG

Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)

Also known as: Bosulif
Chronic Myeloid Leukaemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CML out-patient clinics

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Liverpool Hospital

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG5 1PB, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

bosutinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 10, 2015

Study Start

July 15, 2015

Primary Completion

January 16, 2017

Study Completion

January 16, 2017

Last Updated

October 3, 2023

Results First Posted

September 13, 2018

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

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/data\_requests.

Locations

GB(3)