Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma
The purpose of this study is to assess the antitumor effects and safety of bendamustine
 hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle
 cell lymphoma.
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy
 using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide,
 doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent
 Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride
 has a unique structure compared with the marketed agents, and has an innovative mechanism of
 action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives
 for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.
Inclusion Criteria:

 Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below.
 No restrictions regarding gender.

 -  Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's
 lymphoma or mantle cell lymphoma.

 -  Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in
 the case of antibody therapy) after completion of prior therapy and who are judged to
 carry no effect from the prior therapy.

 -  Patients aged from 20 to less than 75 years.

 -  Performance Status (P.S.): 0 or 1.

 -  Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung,
 liver, and kidney functions).

 -  Patients from whom written consent to participate in this study has been obtained.

 Exclusion Criteria:

 Patients who meet any of the following criteria will be excluded.

 -  Patients with apparent infections.

 -  Patients with serious complications (hepatic failure or renal failure).

 -  Patients with complication or history of serious heart failure (e.g. cardiac
 infarction, ischemic heart disease).

 -  Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).

 -  Patients who are known to be positive for HBV, HCV or HIC.

 -  Patients receiving other investigational drugs within 3 months before registration in
 the study.

 -  Patients with allogenic bone-marrow transplant.

 -  Women who are pregnant, of childbearing potential, or lactating.

 -  Patients who do not agree to contraception.

 -  Otherwise, patients who are judged by the investigator as being unsuitable for
 inclusion in the study.