Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle cell Lymphoma, Transformed lymphoma, transformed to diffuse large B-cell lymphoma, Follicular Lymphoma
Brief 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.
Interventions
DRUGSyB 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).
DRUGRituximab
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).
Sponsors
SymBio Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity | Treatment period |
Secondary
| Measure | Time frame |
|---|---|
| CR rate and the overall response rate, determination by Independent Review Committee | Treatment period |
Countries
Japan
Outcome results
None listed