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

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.

• Non-Hodgkin's Lymphoma
• Diffuse Large B-cell Lymphoma
• Mantle Cell Lymphoma
• Follicular Lymphoma

• Drug: SyB L-0501
  The administration of SyB L-0501 90 mg/m2 or 120 mg/m2/day on Day 2 and Day 3 will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).
  Other Name: Bendamustine hydrochloride
• Drug: Rituximab
  The administration of rituximab 375 mg/m2 on Day 1 of each cycle will be followed by 18 days of observation. In the absence of adverse events or progressive disease, treatment will be repeated up to a maximum of 6 cycles, where 1 cycle is the 21-day treatment period (3 days of administration and 18 days of observation).

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