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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 31, 2021

Arms, Groups and 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Incyte Biosciences UK
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael Thompson, MD, Study Director, Incyte Biosciences UK

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