Lymphoma, B-Cell, Lymphoma, Low-Grade, Non-Hodgkin's Lymphoma
Conditions
Keywords
Antigen, CD20
Brief summary
The purpose of this study is to investigate the antitumor effect and safety of the product for relapsed or refractory indolent B-cell non-Hodgkin's lymphomas.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Interventions
DRUGZevalin (SH L 749 , BAY86-5128)
0,3mCi/kg
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* Platelet counts of \>/= 100,000/mm3 * Absolute neutrophil counts of \>/= 1,200/mm3 * Bone marrow involvement \< 25%
Exclusion criteria
* Patients who received hematopoietic stem cell transplantation, including bone marrow transplantation, peripheral blood stem cell transplantation, etc. * Patients presenting with marked bone marrow hypocellularity (any suspected bone marrow hypocellularity should be confirmed by bone marrow biopsy) * Patients with previous myocardial infarction within the past 1 year, with heart disease that requires treatment or with pulmonary dysfunction * Patients with serious concomitant diseases (cardiac failure, renal failure, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best overall response rates (the percentage of patients who achieved PR or better response) | After 9 weeks or 13 weeks |
| The incidence of critical toxicity | During treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation | During treatment period |
| Complete response (CR or CRu) rates | After 9 weeks or 13 weeks |
| Progression-free survival (PFS) | After end of study |
Countries
Japan
Outcome results
None listed