Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma

Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)

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.