Registry for patients with Chronic Myeloid Leukemia who stop treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to collect and analyze data from Italian patients with Philadelphia-positive chronic phase Chronic Myeloid Leukemia (CP-CML) who have discontinued Tyrosine Kinase Inhibitors (TKIs). The study includes both retrospective and prospective cohorts, gathering clinical data from existing medical records as well as new data from patients who stop TKI therapy. The goal is to assess the feasibility and safety of treatment-free remission in this patient population. Participants will not undergo any additional procedures outside of standard clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with CP-CML, treated with TKI monotherapy or TKI in association with other drugs (such as interferon, BCR-ABL1 peptidic vaccine and others)
* Treatment with TKI discontinued for any reason
* Deep Molecular Response (DMR), defined as MR4 (BCR-ABL1 ratio ≤ 0.01% with at least 10,000 ABL1 copies), or MR4.5 (BCR-ABL1 ratio ≤ 0.0032% with at least 32,000 ABL1 copies), or MR5 (BCR-ABL1 ratio ≤ 0.001% with at least 100,000 ABL1 copies), confirmed at least three times before TKI discontinuation. In patients who discontinued TKIs before the establishment of molecular standardization, DMR will be defined as a level of BCR-ABL1 transcript undetectable by qPCR or by qualitative PCR, confirmed in at least two controls.
* Participant is willing and able to give informed consent for participation in the study Data regarding patients discontinuing in less than DMR (as defined above) will be collected and analysed separately.

Exclusion Criteria:

* Patients who were diagnosed with accelerated or blastic phase CML will be excluded

Where it's running

• Division of Hematology-AO Mauriziano Hospital, University of Turin
  Turin, Italy Recruiting

Study contacts

• Study coordinator: Carmen Fava, MD, PhD
• Email: carmen.fava@unito.it
• Phone: 0115085523

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.