CALLS (INCB 84344-401)

About this trial

The purpose of this observational study is to evaluate the prevalence of mutations in patients with Chronic Myeloid Leukaemia (CML) who meet the European Leukaemia Net (ELN) criteria for warning or failure and patients with Philadelphia-positive Acute Lymphoid Leukaemia (Ph+ ALL) with detectable BCR-ABL currently being treated with first or subsequent Tyrosine Kinase Inhibitor (TKI) therapy in the UK, Ireland, or France using Next-Generation Sequencing.

A clinically routine blood sample will be sent to Kings Laboratory in London for analysis after which patients physicians will be notified of the presence or absence of mutations.

CML patients must meet the European Leukaemia Net (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.

Patient Profile

Participants with Chronic Myeloid Leukaemia (CML) and Philadelphia-positive Acute Lymphoid Leukaemia (Ph+ALL) who are being treated with their first or subsequent tyrosine kinase inhibitor (TKI) therapy.

Where’s this trial being run?

University Hospital Waterford

Can I join this study / trial?

The first thing you do is to talk to your doctor and/or the cancer trials research team in your hospital. The contact details for the cancer trials research units in Ireland is here.

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For more detailed information


Here’s a list of questions you may have for your doctor or local cancer research team.

Summary Data

Name: CALLS (INCB 84344-401)
Number: 18-48
Full 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

Principal Investigator: Dr El Hassadi (University Hospital Waterford)
Type: Industry Sponsored

Incyte Biosciences UK

Recruitment Started: Global: December 2017
Ireland: September 2019
Global Recruitment Target: 400
Ireland Recruitment Target: Not specified