No registrations found.
ID
Source
Brief title
Health condition
CML
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of nilotinib present in seminal fluid in relation to the plasma concentration.
Secondary outcome
Calculated maximal concentration nilotinib absorbed by the partner, using the volume of distribution of the tyrosine kinase inhibitors and the percentage in seminal fluid found in this study.
Background summary
CML requires life-long treatment with nilotinib in most patients. As at least 25% of patients is below 40 years and life expectancy seems normal in well responding patients, sexualrelated issues are of major importance. Currently, use of condoms is advised for any male patient, in order to protect their sexual partners against TKI exposure. If this study shows very low and acceptable TKI levels in seminal fluid, condoms may no longer be required in cases where contraception is not needed.
The patients burden consists of two extra blood samples by Dried Blood Spot (DBS) and the effort of collecting and delivery of seminal fluid at two different time points. Patients may feel embarrassment with participation in the study.
Study objective
To determine the level of nilotinib detectable in seminal fluid of men treated with this tyrosine kinase inhibitor And to form an advise if condoms are necessary to protect their sexual partners from exposure to nilotinib.
Study design
2 measure moments with 1 month in between
Intervention
Males have to collect seminal fluid at two different time points with 1 month between collection points. Blood samples will be drawn at the same intervals, within one hour of collection of semen sample.
Inclusion criteria
• male patients
• aged >18 years
• use of nilotinib for a minimal period of 1 month in chronic phase of CML
• willing and capable of donating a semen sample for pharmacological analysis
Exclusion criteria
• Refractory CML with persistent leucocytosis
• Sterilisation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6652 |
| NTR-old | NTR6886 |
| Other | METc (VUmc) : 2017.130 |