CALLS = CML and ALL Low Level Mutation Study in the UK [UK]

Study title

CALLS Study = CML and ALL Low Level Mutation Study

Scientific 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-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing. (ClinicalTrials.gov no NCT03647215)

Indication and most important 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 tyrosin kinase inhibitor (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 OR
Ph+ve ALL patients with any level of BCR-ABL/ABL IS transcripts who are not eligible for UKALL 14 or are not currently enrolled in UKALL 14

Short description of intervention

This is an observational 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.

Type of study

Other trials

Current status

Recruiting

Study sponsor

Incyte Biosciences UK

Scientific lead / contact

Study Director: Michael Thompson, MD Incyte Biosciences UK

Principal investigator

Hugues de Lavallade

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study description on the NHS website

Study centers / principal investigators

UK

Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ

Royal Devon & Exeter Hospital
Exeter, Devon, EX2 5DW

Derriford Hospital
Plymouth, Devon, PL6 8DH

Queen's Hospital
Romford, Essex, RM7 0AG

Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY

Medway Maritime Hospital
Gillingham, Kent, ME75NY

Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR

Royal Oldham Hospital
Manchester, Lancashire, OL1 2JH

Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH

Ipswich Hospital
Ipswich, Suffolk, IP4 5PD

Heart of England NHS Foundation Trust
Birmingham, West Midlands, B9 5SS

Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ

King's College Hospital
London, SE5 9RS

 


 
   
 

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