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Trial record 1 of 1 for:    INCB 84344-401
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CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey

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ClinicalTrials.gov Identifier: NCT03647215
Recruitment Status : Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( Incyte Biosciences UK )

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
Chronic Phase Chronic Myelogenous Leukemia Accelerated Phase Chronic Myelogenous Leukemia Blastic Phase Chronic Myelogenous Leukemia Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia

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Study Type : Observational
Estimated Enrollment : 400 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 : December 18, 2017
Actual Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021


Group/Cohort
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.



Primary Outcome Measures :
  1. Percentage of participants with any mutation [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.

  2. Frequency of all specific mutations [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to approximately 1 month per individual participant. ]
    All samples will be processed by NGS.

  4. Frequency of individual mutations in Ph+ ALL [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647215


Locations
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Sponsors and Collaborators
Incyte Biosciences UK
Investigators
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Study Director: Michael Thompson, MD Incyte Biosciences UK
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Responsible Party: Incyte Biosciences UK
ClinicalTrials.gov Identifier: NCT03647215    
Other Study ID Numbers: INCB 84344-401
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation ( 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:
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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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes