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

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ClinicalTrials.gov Identifier: NCT03647215
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences UK )

Tracking Information
First Submitted Date August 23, 2018
First Posted Date August 27, 2018
Last Update Posted Date April 18, 2019
Actual Study Start Date December 18, 2017
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 23, 2018)
  • Percentage of participants with any mutation [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
  • Frequency of all specific mutations [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03647215 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 23, 2018)
  • Percentage of participants with individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [ Time Frame: Up to approximately 1 month per individual participant. ]
    Participants in all phases of CML (CP, AP, and BP) will be enrolled.
  • Frequency of individual mutations in chronic phase (CP)-CML, accelerated phase (AP)-CML, and blast phase (BP)-CML [ Time Frame: Up to approximately 1 month per individual participant. ]
    Participants in all phases of CML (CP, AP, and BP) will be enrolled.
  • Percentage of participants with individual mutations in Ph+ ALL [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
  • Frequency of individual mutations in Ph+ ALL [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
  • Percentage of participants with individual mutations by whether a participant is intolerant or resistant to their previous TKI [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
  • Frequency of individual mutations by whether a patient is intolerant or resistant to their previous TKI [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.
  • Percentage of participants with individual mutations by BCR-ABL level [ Time Frame: 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.
  • Frequency of individual mutations by BCR-ABL level [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Approximately 50 centers in the UK, Ireland and France that treat adult patients with CML and Ph+ ALL will be selected for participation in the study. The sites selected will be a mixture of hospital and academic centers.

The target study population will include adult patients with CML who meet the ELN criteria for warning or failure or have high SOKAL score > 0.8 or presence of additional chromosomal abnormalities (ACAs), all with detectable BCR-ABL levels. Ph+ ALL patients must have detectable BCR-ABL levels. Patients will be taking their first or subsequent TKI.

Consecutive patients within each prescriber's practice who meet the enrollment criteria and provide informed consent will be invited to enroll into the study.

Repeat NGS KD mutation testing is permitted under the protocol as deemed part of the standard management of patients.

Condition
  • Chronic Phase Chronic Myelogenous Leukemia
  • Accelerated Phase Chronic Myelogenous Leukemia
  • Blastic Phase Chronic Myelogenous Leukemia
  • Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 23, 2018)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility 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:

    • 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).

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03647215
Other Study ID Numbers INCB 84344-401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: Blood samples will be identifiable by a code consisting of numbers and initials. Samples may be stored and tested for up to 5 years after the completion of the study.
Responsible Party Incyte Corporation ( Incyte Biosciences UK )
Study Sponsor Incyte Biosciences UK
Collaborators Not Provided
Investigators
Study Director: Michael Thompson, MD Incyte Biosciences UK
PRS Account Incyte Corporation
Verification Date April 2019