Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
[Treatment period]
No
Kensei Tobinai, MD, PhD
Study Chair
National Cancer Center Hospital
Japan: Ministry of Health, Labor and Welfare
2007002
NCT00612183
December 2007
September 2009
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