CALLS - CML and ALL Low Level Mutation Study
Research type
Research Study
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-ABL1 Currently Being Treated With First or Subsequent TKI Therapy in the UK Using Next Generation Sequencing
IRAS ID
225694
Contact name
Hugues de Lavallade
Contact email
Sponsor organisation
Incyte Corporation
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
Patients diagnosed with Chronic Myeloid Leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ALL)can have genetic mutations in the DNA of their disease cells which affects the effectiveness of drugs called tyrosine kinase inhibitors which can successfully treat CML and Ph+ALL for long periods. There are over one hundred mutations that affect the effectiveness of TKIs and some patients may have more than one mutation present.
The current technique for identifying mutations can pick up those present in more than 20% of disease cells, but a new technique called Next Generation Sequencing (NGS) is more sensitive and can identify mutations present in more than 3% of disease cells.
This study is measuring the proportion of patients in the UK who have genetic mutations present in >3% of their disease cells using NGS. At present this information is unknown. The results may benefit this patient population in the future by affecting how patients are managed.
When mutations are identified during the study, the patient's treating physician will be informed and he/she will discuss the results with the patient and may make changes to the patient's treatment. This study is non-interventional and any changes to treatment are at the treating physician's discretion.
The study will be conducted in 40 sites (400 patients) around the UK in Haematology Departments who care for patients with CML and Ph+ALL. Each patient will provide written informed consent and will then provide a blood sample, and a form detailing demographics, diagnosis and treatment history will be completed to send with the blood sample. In some cases a repeat blood sample will be required.
Selected anonymous blood samples will be shared with one of the study investigators based at the University of Wales who will use them to validate another more sensitive technique for measuring a specific mutation.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1167
Date of REC Opinion
8 Aug 2017
REC opinion
Further Information Favourable Opinion