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Pharmacogenetics and metabolism of cyclophosphamide in paediatric non-Hodgkin’s Lymphoma - Cyclophosphamide in NHL

Pharmacogenetics and metabolism of cyclophosphamide in paediatric non-Hodgkin’s Lymphoma - Cyclophosphamide in NHL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-003731-31-GB
Enrollment
50
Registered
2005-07-25
Start date
2005-03-09
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

non-Hodgkin's Lymphoma

Interventions

Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Pharmaceutical Form: Intravenous infusion

Sponsors

University Hospitals of Leiceter NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Age =18 years at diagnosis b) Diagnosis of B-cell non-Hodgkin's lymphoma c) Recieving cyclophosphamide as part of standard treatment d) Single or double lumen canteral venous catheter in place e) Written informed consent f) Protocol approval by national and local ethics committee Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Failure to complile with any of the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Secondary Objective: To confirm previous preliminary findings that the matabolism of cyclophosphamide differs between those patients with recurrent disease and those who remain disease free after treatment. To identify those patients who will benefit from standard therapy prior to or during early treatment as distinct from those patients who are identified as being at high risk of recurrence. To obtain pharmacokinetic/pharmacogenetic information which could be used in future studies to optimise the treatment of B-cell non-Hodgkin's lymphoma. ;Main Objective: To test the hypothesis that inital response of B-cell non-Hodkin's lymphoma is determined by metabolic and pharmacogenetic factors relating to cyclophosphamide.;Primary end point(s): To identify those patients who will benefit from standard therapy prior to or during early treatment. Those patients who are identified as being at risk of recurrence may be offered treatment modification or alternative therapy in future studies.

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026