Tyrosine kinase inhibitors and erectile dysfunction in men with chronic myeloid leukemia

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 is a national, multicenter observational study with retrospective and prospective parts that follows adult men with chronic‑phase Philadelphia chromosome–positive CML who started frontline TKI therapy between January 1, 2015 and January 31, 2022. Retrospective data will be collected from medical records on ED onset, cardiac tests, lab results, and BCR-ABL levels, and participants will be followed prospectively for up to 24 months to monitor new ED, cardiovascular events, and resolution after stopping therapy. The study compares incidence across TKIs (imatinib, dasatinib, nilotinib, bosutinib, ponatinib) and explores links between ED and cardiovascular toxicity as well as reversibility in patients who reach treatment‑free remission. No extra tests beyond routine clinical care are required, and about 350 patients are expected to be enrolled.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with chronic phase Philadelphia chromosome-positive (Ph+) and/or BCR-ABL-positive CML.
* Patients starting frontline treatment with TKIs between 01st January 2015 and 31st January 2022.
* Age greater than or equal to 18 years and not exceeding 75 years at the time of starting therapy.
* Male sex.
* Exposure to Hydroxyurea or Anagrelide before the initiation of TKI therapy is allowed
* Ability to provide informed consent, as demonstrated by a clear understanding of the study's objectives and procedures and the ability to make an informed and voluntary decision to participate
* Signed written informed consent according to ICH/EU/GCP and national and local laws.

Exclusion Criteria:

* Patients with advanced phases (accelerated or blastic phase) Ph+ and/or BCR-ABL+ CML
* Patients who experienced ED before TKI initiation

Where it's running

• Azienda USL IRCCS di Reggio Emilia
  Reggio Emilia, Re, Italy Recruiting

Study contacts

• Principal investigator: Isabella Capodanno, MD — Azienda USL Reggio Emilia - IRCCS
• Study coordinator: Isabella Capodanno, MD
• Email: isabella.capodanno@ausl.re.it
• Phone: 0522295511

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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.