Distribution of NIlotinib in semen in men treated for chronic Myeloid leukaemiA

Distribution of NIlotinib in semen in men treated for chronic Myeloid leukaemiA - DANIMA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47098

Enrollment

Registered

2017-08-09

Start date

2018-03-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer of the white bloodcells Chronic Myeloid leukaemie

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Refractory chronic myeloid leukaemia with persistent leukocytosis

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the percentage of nilotinib present in seminal fluid in relation to the plasma concentration.	—

Secondary

Measure	Time frame
The secondary endpoint is the 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.	—

Countries

Netherlands

Outcome results