A Potential Relationship Between Treatment With Tyrosine Kinase Inhibitors and Erectile Dy
Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome, resulting in the constitutive activation of the BCR-ABL1 tyrosine kinase. The advent of tyrosine kinase inhibitors (TKIs) has revolutionized the management of CML, trasforming it from a fatal di
| Condition(s) | Chronic Myelocytic Leukemia, Erectile Dysfunctions, CVD - Cardiovascular Disease, Tyrosine Kinase Inhibitor |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm characterized by the presence of the Philadelphia chromosome, resulting in the constitutive activation of the BCR-ABL1 tyrosine kinase. The advent of tyrosine kinase inhibitors (TKIs) has revolutionized the management of CML, trasforming it from a fatal disease to a chronic condition with excellent long-term outcomes for the majority of patients. The introduction of tyrosine kinase inhibitor (TKI) based treatment for CML has revolutionized the management of this previously fatal disease, achieving sustained disease-control in more than 90% of patients. However, as patients with CML are often required to undergo lifelong TKI therapy to maintain disease control, concerns regarding the long-term safety and tolerability of these a |
| Who can participate | 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/ |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Lead sponsor | Azienda USL Reggio Emilia - IRCCS |
| Locations | Reggio Emilia, RE, Italy |
| Start date | 2025-07-01 |
| NCT ID | NCT07061145 |
| Official listing | https://clinicaltrials.gov/study/NCT07061145 |