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

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Treatments: Bendamustine Hydrochloride

Criteria

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.