Clincosm LogoSign in Get a demo

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

Sponsor
Incyte Biosciences UK (Industry)
Overall Status
Completed
CT.gov ID
NCT03647215
Collaborator
(none)
427
Enrollment
33
Locations
42.4
Actual Duration (Months)
12.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    427 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Cohort Study To Establish the Prevalence of Mutations in Patients With CML Who Meet the ELN Criteria for Warning or Failure and Patients With Ph+ ALL With Detectable BCR-ABL Currently Being Treated With First or Subsequent TKI Therapy in the UK, Ireland, or France Using Next-Generation Sequencing
    Actual Study Start Date :
    Dec 18, 2017
    Actual Primary Completion Date :
    Mar 31, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    All Participants

    Participants with CML and Ph+ALL who are being treated with their first or subsequent TKI therapy. CML patients must meet the ELN criteria for warning and failure ) or have high SOKAL score (>0.8) or presence of additional chromosomal abnormalities (ACAs) and have detectable BCR-ABL levels. Ph+ALL patients need detectable BCR-ABL levels only.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with any mutation [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    2. Frequency of all specific mutations [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    Secondary Outcome Measures

    1. Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [Up to approximately 1 month per individual participant.]

      Participants in all phases of CML (CP, AP, and BP) will be enrolled.

    2. Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [Up to approximately 1 month per individual participant.]

      Participants in all phases of CML (CP, AP, and BP) will be enrolled.

    3. Percentage of participants with individual mutations in Ph+ ALL [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    4. Frequency of individual mutations in Ph+ ALL [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    5. Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    6. Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS.

    7. Percentage of participants with individual mutations by BCR-ABL level [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS. BCR-ABL levels defined as > 0.1% to 1% international scale (IS), > 1% to 10% IS, > 10% IS.

    8. Frequency of individual mutations by BCR-ABL level [Up to approximately 1 month per individual participant.]

      All samples will be processed by NGS. BCR-ABL levels defined as > 0.1% to 1% international scale (IS), > 1% to 10% IS, > 10% IS.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    • BCR-ABL/ABL IS transcripts > 10% at 3 months

    • BCR-ABL/ABL IS transcripts > 1% at 6 months

    • BCR-ABL/ABL IS transcripts > 0.1% at 12 months or later

    • Patients with CML must not currently be in MMR (ie, have disease with BCR-ABL1/ABL1 transcripts > 0.1% IS).

    OR

    • Patients with Ph+ ALL with any level of BCR-ABL/ABL IS transcripts. Patients with Ph+ ALL should have BCR-ABL1/ABL1 transcript levels > 0.1% and should not be currently enrolled in UKALL14 but may have relapsed during or after participation in UKALL14.

    • Patients with an intermediate or high Sokal score (> 0.8) can be recruited into the study from 3 months after diagnosis, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months.

    • Patients with additional chromosomal abnormalities at diagnosis and patients with AP-CML may be recruited into the study, irrespective of BCR-ABL1/ABL1 transcript levels at 3 months and beyond provided BCR-ABL1/ABL1 transcript levels are > 0.1% IS. It is recommended that these patients have mutational analysis performed every 3 months irrespective of BCR-ABL1/ABL1 transcript levels until they reach MR3/MMR (BCR-ABL1/ABL1 < 0.1% IS).

    • Any patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results.

    • Patients who have the ability to understand the requirements of the study and provide written informed consent.

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Limerick University Hospital Limerick Dooradoyle Ireland V94 F858
    2 University Hospital Waterford Waterford Ireland X91 ER8E
    3 Royal Cornwall Hospital Truro Cornwall United Kingdom TR1 3LQ
    4 Royal Devon & Exeter Hospital Exeter Devon United Kingdom EX2 5DW
    5 Derriford Hospital Plymouth Devon United Kingdom PL6 8DH
    6 Broomfield Hospital Chelmsford Chelmsford Essex United Kingdom CM1 7ET
    7 Queen's Hospital Romford Essex United Kingdom RM7 0AG
    8 Aberdeen Royal Infirmary Aberdeen Foresterhill United Kingdom AB25 2ZN
    9 Queen Alexandra Hospital Portsmouth Hampshire United Kingdom PO6 3LY
    10 Medway Maritime Hospital Gillingham Kent United Kingdom ME75NY
    11 Blackpool Victoria Hospital Blackpool Lancashire United Kingdom FY3 8NR
    12 Royal Oldham Hospital Manchester Lancashire United Kingdom OL1 2JH
    13 Queens Medical Centre Nottingham Nottinghamshire United Kingdom NG7 2UH
    14 Ipswich Hospital Ipswich Suffolk United Kingdom IP4 5PD
    15 Heart of England NHS Foundation Trust Birmingham West Midlands United Kingdom B9 5SS
    16 Russells Hall Hospital Dudley West Midlands United Kingdom DY1 2HQ
    17 St Bartholomew's Hospital London West Smithfield United Kingdom EC1A 7BE
    18 Bradford Royal Infirmary Bradford West Yorkshire United Kingdom BD9 6RJ
    19 St James's University Hospital Leeds West Yorkshire United Kingdom LS9 7TF
    20 Monklands Hospital Airdrie United Kingdom ML6 0JS
    21 Bristol Haematology and Oncology Centre Bristol United Kingdom BS2 8ED
    22 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    23 University Hospital Wales Cardiff United Kingdom CF14 4XW
    24 Croydon University Hospital, Croydon Health Services NHS Trust Croydon United Kingdom CR7 7YE
    25 Western General Hospital Edinburgh United Kingdom EH4 2XU
    26 Beatson West of Scotland Cancer Centre Glasgow United Kingdom G12 0YN
    27 Guy's Hospital London United Kingdom SE1 9RT
    28 King's College Hospital London United Kingdom SE5 9RS
    29 The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust Middlesbrough United Kingdom TS4 3BW
    30 Oxford University Hospitals NHS Foundation Trust Oxford United Kingdom OX4 2PG
    31 Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS FT Sheffield United Kingdom S10 2JF
    32 Royal Stoke University Hospital, Cancer Centre, University Hospitals of North Midlands NHS Trust Stoke-on-Trent United Kingdom ST4 6QG
    33 Singleton Hospital Swansea United Kingdom SA2 8QA

    Sponsors and Collaborators

    • Incyte Biosciences UK

    Investigators

    • Study Director: Michael Thompson, MD, Incyte Biosciences UK

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Biosciences UK
    ClinicalTrials.gov Identifier:
    NCT03647215
    Other Study ID Numbers:
    • INCB 84344-401
    First Posted:
    Aug 27, 2018
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Biosciences UK
    Chronic myeloid leukemia
    chronic phase
    accelerated phase
    blast phase
    Philadelphia chromosome-positive acute lymphoblastic leukemia
    tyrosine kinase inhibitor
    Additional relevant MeSH terms:
    Leukemia
    Precursor Cell Lymphoblastic Leukemia-Lymphoma
    Leukemia, Lymphoid
    Leukemia, Myeloid
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Leukemia, Myeloid, Chronic-Phase
    Blast Crisis
    Leukemia, Myeloid, Accelerated Phase
    Philadelphia Chromosome

    Study Results

    No Results Posted as of Aug 16, 2021