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.
Leukemia - CML, Leukemia - ALL
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
Incyte Study ID:
INCB 84344-401
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Biosciences UK
Collaborator:
N/A
Study Contact Information:
Study Complete
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)
PRODUCT
COLLABORATORS
N/A
DATE
Dec 2017 - Mar 2021
TYPE
Observational
PHASE
N/A
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
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).
Clinical Study Locations
Location
Status
Location
University Hospital Waterford
Waterford, Ireland, X91 ER8E
Status
Completed
Location
Limerick University Hospital
Limerick, Dooradoyle, Ireland, V94 F858
Status
Completed
Location
Monklands Hospital
Airdrie, United Kingdom, ML6 0JS
Status
Completed
Location
Bristol Haematology and Oncology Centre
Bristol, United Kingdom, BS2 8ED
Status
Completed
Location
Addenbrooke’s Hospital
Cambridge, United Kingdom, CB2 0QQ
Status
Completed
Location
University Hospital Wales
Cardiff, United Kingdom, CF14 4XW
Status
Completed
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
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.