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) studied | Indolent non Hodgkin's lymphomas |
| Date of first enrollment | 2004/11/01 |
| Target sample size | 52 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | The dosage and schedule of rituximab in this study is 375 mg/m2 x eight weekly infusions. |
Outcome(s)
| Primary Outcome | Overall response rate (ORR) for eligible patients |
|---|---|
| Secondary Outcome | 1."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 minimum | 20years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. 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
| Primary Sponsor | Zenyaku Kogyo Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Zenyaku Kogyo Co., Ltd. |
| Secondary ID(s) |
Contact
| 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 |