Clinical trial · Observational
CALLS: CML and Ph+ALL Low Level Mutation Prevalence Survey
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
NCT03647215CI-TRIAL-00053296completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Chronic Phase Chronic Myelogenous Leukemia | Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- description
- Participants with CML and Ph+ALL who are being treated with their first or subsequent TKI therapy. CML patients must meet the 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.
Primary outcomes (2)
- measure
- Percentage of participants with any mutation
- timeFrame
- Up to approximately 1 month per individual participant.
- description
- All samples will be processed by NGS.
- measure
- Frequency of all specific mutations
- timeFrame
- Up to approximately 1 month per individual participant.
- description
- All samples will be processed by NGS.
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 patients who have previously undergone testing for KD mutations, irrespective of KD mutational analysis test results. * Patients who have the ability to understand the requirements of the study and provide written informed consent. 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).
References
Publications (0)
Data not yet available
No reference posted for this study.