Determination of the pharmacokinetics of rituximab and antibodies to rituximab in patients with a B-cell CD20+ malignancy who are treated with rituximab as single agent or rituximab in combination with chemotherapy or are on maintenance therapy with rituximab

Determination of the pharmacokinetics of rituximab and antibodies to rituximab in patients with a B-cell CD20+ malignancy who are treated with rituximab as single agent or rituximab in combination with chemotherapy or are on maintenance therapy with rituximab - Pharmacokinetics and antibodies rituximab during standard treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31559

Enrollment

Registered

2008-07-01

Start date

2008-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

B-cell non-Hodgkin lymphoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: · All patients with a CD20+ B-cell malignancy who are treated with rituximab are eligible for this study. · Written informed consent

Exclusion criteria

Exclusion criteria: no written informed consent

Design outcomes

Primary

Measure	Time frame
The results of the determination of the rituximab levels and development of antibodies against rituximab will be correlated to the patient data in a multivariate analysis. The parameters that will be included into the multivariate analysis are: Age of the patient, sex, type of CD20+ B-cell malignancy, tumor load, type of chemotherapy if applicable, number of cycles given to the patient, number of maintenance treatment, renal function, blood counts and presence of CD20+ cells in the peripheral blood. We wish to get answer to the following questions: · Intra-patient: correlation of the pharmacokinetics with tumor load, the number of cycles given, duration of maintenance treatment, renal function, influence of chemotherapy on the pharmacokinetics of rituximab, if the pharmacokinetics of rituximab come to a steady state situation and if so, is this correlated to tumor load, response, kind of chemotherapy, renal function · Inter patient: variation between patients with regard to the parameters mentioned in the intra patient variation and the parameters which determine this variation.	—

Measure

Time frame

The results of the determination of the rituximab levels and development of antibodies against rituximab will be correlated to the patient data in a multivariate analysis. The parameters that will be included into the multivariate analysis are: Age of the patient, sex, type of CD20+ B-cell malignancy, tumor load, type of chemotherapy if applicable, number of cycles given to the patient, number of maintenance treatment, renal function, blood counts and presence of CD20+ cells in the peripheral blood. We wish to get answer to the following questions: · Intra-patient: correlation of the pharmacokinetics with tumor load, the number of cycles given, duration of maintenance treatment, renal function, influence of chemotherapy on the pharmacokinetics of rituximab, if the pharmacokinetics of rituximab come to a steady state situation and if so, is this correlated to tumor load, response, kind of chemotherapy, renal function · Inter patient: variation between patients with regard to the parameters mentioned in the intra patient variation and the parameters which determine this variation.

—

Secondary

Measure	Time frame
None	—

Countries

Netherlands

Outcome results