A Multicenter Phase I Clinical Trial to Assess the Safety of Two Consecutive Days of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma
Aggressive B-cell non-Hodgkin's lymphoma patients with prior therapy who satisfy the
conditions listed below. No restrictions regarding gender.
- Patients with the following histologically confirmed CD20(+) B-cell non-Hodgkin's
1. Diffuse large B-cell lymphoma
2. Mantle cell lymphoma
3. Transformed lymphoma
4. Follicular lymphoma (Grade 3)
- Fail to CR in prior chemotherapy, or relapse following CR or recurrence following PR.
- Patients who are judged to carry no effect from the prior therapy (cancer
chemotherapy, antibody therapy and radiation/ radiotherapy.
- Patients aged from 20 to 75 years at the time informed consent is obtained
- Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung,
liver, and kidney functions)
- Patients who can be hospitalized during the first cycle
- Patients capable of personally giving voluntary informed consent in writing to
participate in the study
Patients who meet any of the following criteria will be excluded.
- Patients with serious complications (hepatic or renal failure)
- Patients with complications or medical history of serious cardiac disease (e.g.,
myocardial infarction, ischemic heart disease)
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or
- Patients positive for HBs antigen, HCV antibody, or HIV antibody
- Patients who received other investigational drug or unapproved medication within 3
months before registration in this study
- Patients who had history of hematopoietic stem cell transplantation or
- Patients who are pregnant, of childbearing potential, or lactating
- Patients, whether male or female, who do not agree to contraception
- Patients otherwise judged by investigator or sub investigator to be unsuitable