A Phase I Study of Bendamustine Hydrochloride in Patients With Indolent B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2007-10-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's Lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Treatments: Bendamustine Hydrochloride

Criteria

Inclusion Criteria:

Indolent B cell 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.

• Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.

• Patients aged from 20 to less than 75 years.

• Patients who had agreed in-patient during first course therapy.

• 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 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.