Distribution of NIlotinib in semen in men treated for chronic Myeloid leukaemiA
Recruiting
- Conditions
- cancer of the white bloodcellsChronic Myeloid leukaemie10024324
- Registration Number
- NL-OMON47098
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Inclusion Criteria
male patients
aged >18 years
use of nilotinib for a minimal period of 1 month in chronic phase of chronic myeloid leukaemia
willing and capable of donating a semen sample for pharmacological analysis
Exclusion Criteria
Refractory chronic myeloid leukaemia with persistent leukocytosis
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the percentage of nilotinib present in<br /><br>seminal fluid in relation to the plasma concentration. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoint is the calculated maximal concentration nilotinib<br /><br>absorbed by the partner, using the volume of distribution of the tyrosine<br /><br>kinase inhibitors and the percentage in seminal fluid found in this study.</p><br>