Leukemia - CML, Leukemia - ALL

CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey

Incyte Study ID:
INCB 84344-401
CT.gov ID:
NCT03647215
View Results Summary
Eudra ID:
N/A
Sponsor:
Incyte Biosciences UK
Collaborator:
N/A
Study Contact Information:
+800 00027423 or [email protected]
Study Complete
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Clinical Study Purpose

A multicenter, prospective cohort study of the mutation status of patients with chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who are being treated with first or subsequent tyrosine kinase inhibitor (TKI) therapy in the UK, Ireland, or France.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Leukemia - CML
  • Leukemia - ALL
    • PRODUCT
    COLLABORATORS
    N/A
    DATE
    Dec 2017 - Mar 2021
    TYPE
    Observational
    PHASE
    N/A
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    University Hospital Waterford
    Waterford, Ireland, X91 ER8E
    Name
    Limerick University Hospital
    Limerick, Dooradoyle, Ireland, V94 F858
    Name
    Monklands Hospital
    Airdrie, United Kingdom, ML6 0JS
    Name
    Bristol Haematology and Oncology Centre
    Bristol, United Kingdom, BS2 8ED
    Name
    Addenbrooke’s Hospital
    Cambridge, United Kingdom, CB2 0QQ
    Name
    University Hospital Wales
    Cardiff, United Kingdom, CF14 4XW

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Adult patients (age ≥ 18 years) with CML (in all phases of disease) or Ph+ ALL with detectable BCR-ABL levels who are being treated with a first or subsequent TKI.
    • Patients with CML must meet the warning or failure criteria as per the ELN guidelines for first second and subsequent treatment line, including:

    Exclusion Criteria

    • Patients without detectable BCR-ABL and patients who have switched TKI due to intolerance but who have met the criteria for optimal response (CP-CML, ELN 2013 guidelines).

    Protocol Summary

    Incyte Study ID:
    INCB 84344-401
    Primary Purpose:
    N/A
    Allocation:
    N/A
    Study Design:
    N/A
    Masking:
    N/A
    Interventions:
    N/A
    Enrollment:
    427
    Primary Outcome
    Open

    Percentage of participants with any mutation

    Timeframe: Up to approximately 1 month per individual participant.

    Frequency of all specific mutations

    Timeframe: Up to approximately 1 month per individual participant.

    Secondary Outcome
    Open

    Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML

    Timeframe: Up to approximately 1 month per individual participant.

    Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML

    Timeframe: Up to approximately 1 month per individual participant.

    Percentage of participants with individual mutations in Ph+ ALL

    Timeframe: Up to approximately 1 month per individual participant.

    Frequency of individual mutations in Ph+ ALL

    Timeframe: Up to approximately 1 month per individual participant.

    Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI

    Timeframe: Up to approximately 1 month per individual participant.

    Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI

    Timeframe: Up to approximately 1 month per individual participant.

    Percentage of participants with individual mutations by BCR-ABL level

    Timeframe: Up to approximately 1 month per individual participant.

    Frequency of individual mutations by BCR-ABL level

    Timeframe: Up to approximately 1 month per individual participant.