Non-Hodgkin's Lymphoma
Conditions
Keywords
Non-Hodgkin's Lymphoma, Malignant lymphoma
Brief 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.
Detailed description
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with indolent B-cell Non-hodgkin's lymphoma.
Interventions
DRUGbendamustine hydrochloride
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days) | — |
Secondary
| Measure | Time frame |
|---|---|
| All adverse events or adverse reactions, during the treatment cycle (twenty one days) | — |
| Pharmacokinetics profile | — |
Countries
Japan
Outcome results
None listed