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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
1 cycle; 120 mg/m2/day,2 days concecutively, followed by 19days of oveservation period. (3 to 6 cycles)
Unnamed facility
Kanagawa, Japan
Unnamed facility
Kyoto, Japan
Unnamed facility
Nagoya, Japan
Unnamed facility
Tokyo, Japan
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
All adverse events or adverse reactions, during the treatment cycle (twenty one days)
Pharmacokinetics profile
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