Post-marketing clinical study of rituximab monotherapy at eight weekly infusions in relapsed or refractory patients with indolent B-cell non-Hodgkin's lymphoma
- Conditions
- Indolent non Hodgkin's lymphomas
- Registration Number
- JPRN-UMIN000002974
- Lead Sponsor
- Zenyaku Kogyo Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 52
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) for eligible patients
- Secondary Outcome Measures
Name Time Method 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