A Phase I Clinical Trial of SyB L-0501 in Combination With Rituximab to Patients With Aggressive B-cell Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety of SyB L-0501 in combination with Rituximab to patients with aggressive B-cell non-Hodgkin's lymphoma, and to explore the recommended dose for the Phase II clinical trial.

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

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Treatments: Bendamustine Hydrochloride; Rituximab

Criteria

Inclusion Criteria:

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 lymphoma:

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

Exclusion Criteria:

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 diarrhea)

• 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 radioimmunotherapy

• 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