The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell 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 refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
bendamustine hydrochloride is administered by 60-min drip infusion at 120 mg/m2/day for 2 consecutive days, and the course is then observed for 19 days. This is one cycle and administration is repeated for 3 - 6 cycles. From the second cycle, the dose is reduced or administration is discontinued as required based on adverse events observed in the previous cycle or observation of the course.
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time frame: [Treatment period]
CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
Time frame: [Treatment Period]
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Unnamed facility
Sapporo, Hokkaido, Japan
Unnamed facility
Kagoshima, Kagoshima-ken, Japan
Unnamed facility
Isehara, Kanagawa, Japan
Unnamed facility
Kumamoto, Kumamoto, Japan
Unnamed facility
Kyoto, Kyoto, Japan
Unnamed facility
Sendai, Miyagi, Japan
Unnamed facility
Nagoya, Nagoya, Japan
...and 7 more locations