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.
ID
Bron
Verkorte titel
Aandoening
CML
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of nilotinib present in seminal fluid in relation to the plasma concentration.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
2 measure moments with 1 month in between
Onderzoeksproduct en/of interventie
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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Refractory CML with persistent leucocytosis
• Sterilisation
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6652 |
| NTR-old | NTR6886 |
| Ander register | METc (VUmc) : 2017.130 |