NIPH Clinical Trials Search

UMIN ID: UMIN000002974

Registered date:05/01/2010

Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedIndolent non Hodgkin's lymphomas
Date of first enrollment2004/11/01
Target sample size52
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)The dosage and schedule of rituximab in this study is 375 mg/m2 x eight weekly infusions.


Primary OutcomeOverall response rate (ORR) for eligible patients
Secondary Outcome1."Progression free survival" for eligible patients and "Time to progression" for responder patients 2.frequency and severity of adverse events for all treated patients 3.pharmacokinetic parameters

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria1. Prior treatment history 1)Patients who received rituximab within the past one year. 2)Previous treatment with a murine, chimeric or humanized MoAb other than rituximab 3)Patients with positive human anti-chimeric antibody (HACA) 4)Treatment with investigational new drugs under development at least six months prior to the entry into the study. 5)Previous treatment with hematopoietic growth factors such as granulocyte-colony stimulating factor (G-CSF) within one week prior to the entry. 2. Patients whose lymphoma cells in peripheral blood (PB) exceed 5,000/uL. 3. Concomitant and /or previous diseases 1)Seropositive for human immunodeficiency virus (HIV) antibody. 2)Patients with active hepatitis, ongoing infection and serious illness. 3)Patients with active concomitant malignancies. 4)Presence or history of CNS involvement, or patients with suspicion of CNS involvement. 5)Patients with serious mental disorder. 4. Pregnant or lactating women, women with positive of pregnancy test, or women of child bearing potential. 5. Patients who entered the other clinical studies.

Related Information


public contact
Name Izumi Okugaito
Address 6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650 Japan
Telephone +81-3-3946-1113
Affiliation Zenyaku Kogyo Co., Ltd. Clinical development promotion section
scientific contact
Name Kensei Tobinai, MD, PhD
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
Telephone +81-3-3542-2511
Affiliation National Cancer Center Hospital Hematology Division