CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
Ireland, United Kingdom427 participantsStarted 2017-12-18
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
What they're measuring
1
Percentage of participants with any mutation
Timeframe: Up to approximately 1 month per individual participant.
2
Frequency of all specific mutations
Timeframe: Up to approximately 1 month per individual participant.