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Distribution NIlotinib in semen in men treated for chronic Myeloid leukAemia

Distribution NIlotinib in semen in men treated for chronic Myeloid leukAemia

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26150
Enrollment
10
Registered
2017-11-27
Start date
2017-12-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

CML

Interventions

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 sampl

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Refractory CML with persistent leucocytosis • Sterilisation

Design outcomes

Primary

MeasureTime frame
Percentage of nilotinib present in seminal fluid in relation to the plasma concentration.

Secondary

MeasureTime frame
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.

Contacts

Public ContactM.A. Kuijvenhoven
m.kuijvenhoven@vumc.nl020-4443524

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)