Assessment of time-dependent structural alteration of rituximab in patients

Assessment of time-dependent structural alteration of rituximab in patients - Assessment of time-dependent structural alteration of rituximab in patients

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016713

Enrollment

Registered

2015-03-05

Start date

2015-05-07

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

follicular lymphoma or diffuse large B-cell lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with follicular lymphoma or diffuse large B-cell lymphoma Patients who were not treated with rituximab in the past year and will start treatment with one of three regimens containing rituximab (R-CHOP, R-CVP and RB) Patients who received an explaination of this study and consented it in written form

Exclusion criteria

Exclusion criteria: Patients who could not be took blood sampling at designated time points Patients who need legal representative

Design outcomes

Primary

Measure	Time frame
Plasma concentration of rituximab and the structural alteration of its carbohydrate chains or other flagments	—

Secondary

Measure	Time frame
In vitro assessment of pharmacological effect of isolated rituximab from patients Clinical effects (response rate, blood test values, bone marrow infiltration) Adverse events (clinical test values, presence or absence of infusion reaction)	—

Countries

Japan

Contacts

Public ContactAtsushi Yonezawa

Kyoto University Hospital Department of Clinical Pharmacology & Therapeutics

ayone@kuhp.kyoto-u.ac.jp075-751-3586

Outcome results